EudraCT Protocol Related Data Dictionary

Neil Cordwell:
For EudraCT Form

V4 to V7
Section
Ref (V2)
Form
Ref (V3)
Field Name
Kuljit Kandhari:
FieldScreen
names as
shown in
EU Trial
text
XML Schema
A. Trial Identification
A.1
A.1
Application MS
Neil Cordwell:
Was: Title
of the
Full title
of
Neil
Cordwell:
the trial
trial
for
lay people
Was: Abbreviated
title of trial
Neil Cordwell:
Was: Sponsor
protocol number
A.1
A.1
Application NCA
National Competent
Authority
A.2
A.2
EudraCT number
EudraCT number
A.3
A.3
Full title
Full title of the trial
A.3.1
A.3.1
Lay person title
Title of the trial for lay

people, in easily
understood, i.e. nontechnical, language
A.3
A.3.2
Abbreviated title
Name or abbreviated
title of the trial where
available
A.4
A.4.1
Sponsor protocol code
Sponsors protocol code

number
A.4
A.4.2
Sponsor protocol
version
Sponsor's protocol
version
A.4
A.4.3
Sponsor protocol
version date
Sponsor's protocol date
New
A.4.4
Sponsor protocol
change date
Date of latest change of

the protocol
yyyy-mm-dd
A.6
A.5.1
ISRCTN number
ISRCTN number
A.5.2
A.5.2
US NCT number
US NCT number
R
a
l
f
H
e
r
o
l
d
:
W
o
r
d
i
n
g
t
o
A.5.3
A.5.3
WHO UTRN
c
WHO
Universal Trial
h
Reference
Number
a
(UTRN)
n
g
e
f
A.5.4
A.5.4
Other Identifier Name
o
Other
Identifier - Name
r
3
r
d
C
o
u
n
t
r
y
A.5.4
A.5.4
Other Identifier
Other Identifier Identifier
A.7
A.6
Is resubmission
Is this a resubmission?
Ralf Herold:
If captured in database
A.7
A.6
Resubmission letter
Indicate the
Neil Cordwell:
3rd Country:Competent Authority Decision
resubmission
letter or
else select 'First
submission'
A.7
A.7
Trial part of a PIP
Is the trial part of a

Paediatric Investigation
Plan?
A.8
A.8
PIP Decision number
EMEA Decision number

of Paediatric
Investigation Plan
B. Sponsor
Identificati
on
B.1 and B.3
B.1.1
B.1 and B.3
Sponsor Identification
Details
B.1.1
Sponsor Organisation
B.1.2
Sponsor Contact
N
e
Name
i
l
C
o
r
d
w
e
l
l
:
W
h
a
t
Name of person to
i Z
contact:
o
s
e
T
s
e
k
a
s
:
M name
Given
o
d
i
f
e
Middle
d name
t
o
b
e
a
C
Family
name
T
Zoe
li
Tseka
s
s:
t
The
user
Address:
may
Street
choosAddress
e
multipl
e
countr
ies
t
h
i
s
?
B.1.2
B.1.2.1
Sponsor Contact Given

name
B.1.2
B.1.2.2
Sponsor Contact Middle

name
B.1.2
B.1.2.3
Sponsor Contact Family

Name
B
B
B.1.3
B.1.3
B.1.3.1
Sponsor Address
Sponsor Street Address
of organisation
s
s:
t
The
user
may
choos
e
multipl
e
Town/
city
countr
ies
B.1.3
B.1.3.2
Sponsor Town/City
B.1.3
B.1.3.3
Sponsor Post Code
Post code
B.1.3
B.1.3.4
Sponsor Country
Country
Zoe
Tseka
s:
Telephone
number
user
may
Zoe
enter
Tseka
more
s:
than
TODO
one
ATC
code,
the
restric
Fax
number
tion is
up to
4
B.1.4
B.1.4
Sponsor Telephone
B.1.5
B.1.5
Sponsor Fax
B.1.6
B.1.6
Sponsor Email
E-mail
B.3.1 and B.3.2
B.3.1 and
B.3.2
Sponsor Status
Status of the sponsor

Zoe
Tseka
s:
User
may
choos
e
multipl
e ROA
B.2
B.2
Legal Representative
Identification Details
Zoe
Tseka
s:
User
may
choos
e
For
section B.2, first
multipl
complete
e ROA B.3 below
then select 'Continue'

and then add a legal
representative if
required by Article 19 of
Directive 2001/20/EC.
B.2.1
B.2.1
Legal Rep Organisation Name of organisation
B.2.2
Legal Rep Contact
B.2.2
B.2.2.1
Name of person to
contact:
Legal Rep Given Name Given name
B.2.2
B.2.2.2
Legal Rep Middle name Middle name
B.2.2
B.2.2.3
Legal Rep Family Name Family name
B
B
B.2.3
B.2.3
B.2.3.1
Legal Rep Address

Legal Rep Street
Address
Address:
Street Address
B.2.3
B.2.3.2
Legal Rep Town/City
Town/ city
B.2.3
B.2.3.3
Legal Rep Post Code
Post code
B.2.3
B.2.3.4
Legal Rep Country
Country
B.2.4
B.2.4
Legal Rep Telephone
Telephone number
B.2.5
B.2.5
Legal Rep Fax
Fax number
B.2.5
B.2.6
Legal Rep Email
E-mail
New
B.4
Source of Monetary or Source(s) of Monetary

Material Support
or Material Support for
the clinical trial (repeat
as necessary):
B.4.1
B.4.1
Source of Monetary or
Material Support
organisation name
Name of organisation
B.4.2
B.4.2
Source of Monetary or
Material Support
country
Country
B.5
B.5
Further information
contact
Contact point
designated by the
sponsor for further
information on the trial
New
B.5.1
Further information
contact Organisation
New
B.5.2
Further information
contact name
Functional name of
contact point
B.5.3
B.5.3
B.5.3.1
B.5.3.1
Further information
Address:
contact Address
Contact point for further Street Address
Street Address
B.5.3.2
B.5.3.2
Further information
contact Town/City
Town/ city
B.5.3.3
B.5.3.3
Further information
contact Post Code
Post code
B.5.3.4
B.5.3.4
Further information
contact Country
Country
B.5.4
B.5.4
Further information
contact Telephone
Telephone number
B.5.5
B.5.5
Further information
contact Fax
Fax number
B.5.6
B.5.6
Further information
contact E-mail
E-mail
New
B.5.7
SUSAR Reporting
SUSAR Reporting
indicate the process to
be used for SUSAR
reporting:
Kuljit Kandhari:
New
B.5.7.1
SUSAR Reporting to
NCAs
To National
Competent
V8
Authorities:
New
B.5.7.2
SUSAR Reporting to
EVCTM
To EudraVigilance
Clinical Trial Module:
New
B.5.8
EV Sender Identifier
EV Sender ID
New
B.5.8.1
EV Sender ID
organisation
Organisation name
New
B.5.8.2
EV Sender ID
Identifier
B
C
C
C
Field removed EudraCT
End of Sponsor repeating group Rows
C.
Applicant
Identificati
on
C.1
Request for Authorisation to Competent Authority
C.1.1, C.1.2 and C.1.1, C.1.2 CA Applicant Type

C.1.3
and C.1.3
C.1.1 and C.1.2 and

C.1.3
C.1.4
C.1.4
CA Applicant
Complete the details of

the applicant below
even if they are
provided elsewhere on
the form:
C.1.4.1
C.1.4.1
CA Applicant
Organisation
Name of Organisation
C.1.4.2
C.1.4.2
CA Applicant Contact
Name of contact person
C.1.4.2
C.1.4.2.1
CA Applicant Given
Name
Given name
C.1.4.2
C.1.4.2.2
CA Applicant Middle
name
Middle name
C.1.4.2
C.1.4.2.3
CA Applicant Family
Name
Family name
C
C
C.1.4.3
C.1.4.3
C.1.4.3
C.1.4.3.1
CA Applicant Address
CA Applicant Street
Address
Address:
Street address
C.1.4.3
C.1.4.3.2
CA Applicant Town/City
Town/ city
C.1.4.3
C.1.4.3.3
CA Applicant Post Code Post code
C.1.4.3
C.1.4.3.4
CA Applicant Country
Country
CA Applicant Country
ISO Code
C.1.4.4
C.1.4.4
CA Applicant Telephone Telephone number
C.1.4.5
C.1.4.5
CA Applicant Fax
Fax number
Kuljit K
To be im
EudraCT
C.1.4.6
C.1.4.6
CA Applicant Email
E-mail
C.1.5
C.1.5
C.1.5.1
C.1.5.1
Send XML copy
Do you want a copy of

this data saved on
EudraCT as an XML
File
C.1.5.1.1
C.1.5.1.1
XML copy email x5
E-mail
C.1.5.1.2
C.1.5.1.2
XML copy is secure
Secure E-mail
(EudraLink account)?
C.2
C.2
Request for Opinion of the Ethics Committee
C.2.1, C.2.2,
C.2.1, C.2.2, IEC Applicant Type
C.2.3 and C.2.4 C.2.3 and
C.2.4
Request to receive a
copy of this data as
XML
C.2.1 and C.2.2 and

C.2.3 and C.2.4
C.2.5
C.2.5
IEC Applicant
Organisation
Complete the details of

the applicant below
even if they are
provided elsewhere on
the form:
C.2.5.1
C.2.5.1
IEC Applicant
Organisation
Organisation
C.2.5.2
C.2.5.2
IEC Applicant Contact
C.2.5.2
C.2.5.2.1
IEC Applicant Given

Name
Given name
C.2.5.2
C.2.5.2.2
IEC Applicant Middle

name
Middle name
C.2.5.2
C.2.5.2.3
IEC Applicant Family

Name
Family name
C
C
C
C.2.5.3
C.2.5.3
C.2.5.3
C.2.5.3
C.2.5.3.1
C.2.5.3.2
IEC Applicant Address Address:

IEC Applicant Street
Street address
Address
IEC Applicant Town/City Town/city
C.2.5.3
C.2.5.3.3
IEC Applicant Post

Code
Post code
C.2.5.3
C.2.5.3.4
IEC Applicant Country
Country
C.2.5.4
C.2.5.4
IEC Applicant
Telephone
Telephone number
C.2.5.5
C.2.5.5
IEC Applicant Fax
Fax number
C.2.5.6
D. IMP
Identificati
on
C.2.5.6
IEC Applicant Email
E-mail
Ralf Herold:
Possibly using ATC as a basis, but build the list and
feed to EUTCT
D
D
D.1/D.2
D.1/D.2
Description of the Investigational Medicinal Product Repeating group

Gastro-enterology
- Hepatology
IMP Identification and Status
Details
D.1.1
D.1.1
IMP sequence number
D.1.2 and D.1.3 D.1.2 and

D.1.3
IMP Category
D.2
D.2
IMP Status
D.2.1
D.2.1
IMP has MA
Neurology
Psychiatry
Haematology - Hemostaseology
Oncology
Immunology - Rheumatology - Transplantation
Dermatology
Ophthalmology
Cardio-vascular Diseases
Pneumology - Allergology
Infectious Diseases - Parasitology
Category
Oto-rhino-laryngology
Uro-nephrology
Endocrinology - Gynaecology - Fertility - Metabolism
Neonatology - Paediatric Intensive Care
Status
Pain of the IMP to be
used
in the clinical trial
Anaesthesiology
Vaccines
Diagnostics
Or use MeSH section 3 or ICD10

Has
the IMP to be used
Needs to be multi-select
in the trial a marketing
Kuljit Kandhari:
authorisation?
Not Displayed on the
UI. EV Code in V7 was only used to search for an AS, but n
directly by the user. It is flled automatically by the system and it should be part
sure it is flled in the database.
D.2.1.1
D.2.1.1
If 'Yes', specify the

product to be used in
the trial
D.2.1.1.1
D.2.1.1.1
IMP Trade name
Not displayed
EV Product Index Code
Not displayed
Not
displayed
D.2.1.1.1.1
EV Identifiable Product
Code
EV Product Code
D.2.1.1.2
D.2.1.1.2
MA holder
Name of the Marketing

Authorisation holder
Trade name
Neil Co
3rd Cou
Neil Co
3rd Cou
D.2.1.1.3
D.2.1.1.3
MA number
Marketing Authorisation
number (if Marketing
Authorisation granted
by a Member State)
D.2.1.1.4
D.2.1.1.4
IMP modified
Is the IMP modified in

relation to its Marketing
Authorisation?
D.2.1.1.4.1
D.2.1.1.4.1
IMP modified
specification
If 'Yes', please specify
D.2.1.2
D.2.1.2
Country granting MA
The country which

granted the Marketing
Authorisation
D.2.1.2.1
D.2.1.2.1
Country granting MA is
concerned MS
Is this the Member

State concerned with
this application?
Kuljit Kandhari:
was G.5.1.13
Kuljit Kandhari:
was G.5.1.12
D.2.1.2.2
D.2.2
D.2.1.2.2
D.2.2
Country granting MA is
another MS
Kuljit Kandhari:
was G.5.1.18
Kuljit Kandhari:
Kuljit
Kandhari:
was G.5.1.11
was G.5.1.17
Kuljit Kandhari:
was G.5.1.18.1
Kuljit Kandhari:
Kuljit
Kandhari:
was G.5.1.10
was G.5.1.16
Kuljit Kandhari:
was
G.5.1.15
Kuljit
Kandhari:
was G.5.1.9
Kuljit Kandhari:
was
G.5.1.14
Kuljit
Kandhari:
was G.5.1.8
Is this another Member

State?
For situations where the
IMP to be used in the
CT has a Marketing
Authorisation in the
Member State
concerned but the
protocol allows that any
brand of the IMP with a
in that Member State be
administered to the trial
subjects and it is not
possible to clearly
identify the IMP(s) in
advance of the trial start
Kuljit Kandhari:
G.5.1.7
D.2.2.1
D.2.2.1
Treatment defined only

by AS
In the protocol, is
treatment defined only
by active substance?
Kuljit Kandhari:
was G.5.1.6
Kuljit Kandhari:
was G.5.1.5
D.2.2.1.1
D.2.2.1.1
Kuljit Kandhari:
was G.5.1.1
Kuljit
Kandhari:
G.5.1.3.2
Kuljit Kandhari:
Kuljit Kandhari:
was G.5.1.3.3
was G.5.1.3.1
If 'Yes', give active

substance in D.3.8 or
D.3.9
Kuljit Kandhari:
was:If 'not accepted
give the eventual
anticipated date of
resubmission
Kuljit Kandhari:
was G.5.1.5
D.2.2.2
D.2.2.2
Kuljit Kandhari:
was
G.5.1.1
Kuljit
Kandhari:
G.5.1.3.2
Kuljit Kandhari:
Kuljit Kandhari:
Combinations
of
was G.5.1.3.3
was
G.5.1.3.1
Kuljit
Kandhari:
Kuljit
Kandhari:
marketed
products
was
was G.5.1.4
G.5.1.3
In the protocol, do
treatment regimens
allow different
combinations of
marketed products used
Kuljit
Kandhari:
To appear
only as a according
text
to local
Kuljit
Kandhari:
was
G.5.1.3.4
on
the Kandhari:
UI
Kuljit
clinical
practice
at some
G.5.1.2.3
was G.5.1.2
or all investigator sites
in the MS?
Kuljit Kandhari:
Kuljit
Kandhari:
was G.5.1.2.2
was G.5.1.2.1
D.2.2.2.1
D.2.2.2.1
If 'Yes', give active

substance in D.3.8 or
D.3.9
D.2.2.3
D.2.2.3
D.2.2.3.1
D.2.2.3.1
D.2.2.4
D.2.2.4
IMP identification other
Other:
D.2.2.4.1
D.2.2.4.1
IMP identification other

specification
If 'Yes', then please

specify
D
D
D.2.3
D.2.3.1
D.2.3
D.2.3.1
IMPD Submitted
Full IMPD submitted
IMPD Submitted:
Full IMPD:
D.2.3.2
D.2.3.2
Simplified IMPD
submitted
Simplified IMPD:
D.2.3.3
D.2.3.3
Only SmPC submitted
Summary of product
characteristics (SmPC)
only:
IMP defined by ATC

Group
The products to be
administered as IMPs
are defined as
belonging to an ATC
group
If 'Yes', give the ATC
group of the applicable
authorised codes in the
ATC code field (level 3
or the level that can be
defined) in D.3.3
Kuljit
Kuljit Kandhari:
Kandhari:
was
was G.3.7.11.1
G.3.7.11
Kuljit Kandhari:
was G.3.7.10
Kuljit
Kuljit Kandhari:
Kandhari:
was
was G.3.7.11.1
G.3.7.11
D.2.4
D.2.4.1
D.2.4
D.2.4.1
Kuljit Kandhari:
IMP previously
used for Has the use of the IMP
was G.3.7.10
CT in community
been previously
authorised in a clinical
trial conducted by the
Kuljit Kandhari: sponsor in the
was G.3.7.9
Community?
Kuljit Kandhari:
was G.3.7.8
IMP previously used for If 'Yes', specify which

CT in community MS
Member States:
Kuljit Kandhari:
was G.3.7.7
Kuljit Kandhari:
was G.3.7.6
D.2.5
D.2.5
Kuljit Kandhari:
IMP is orphan
drug
Has the IMP been
was G.3.7.5
designated in this
indication as an orphan
Kuljit Kandhari: drug in the Community?
was G.3.7.4
D.2.5.1
D.2.5.1
Kandhari: If 'Yes', give the orphan

OrphanKuljit
drug number
was G.3.7.3
drug designation
Kuljit Kandhari:
Kuljit Kandhari: number
was G.3.7.1
was G.3.7.2
Kuljit Kandhari:
was G.3.7
D.2.6
D.2.6
IMP subject of scientific Has the IMP been the

advice
subject of scientific
advice related to this
Kuljit Kandhari: clinical trial?
was G.3.6
Kuljit Kandhari:
Kuljit
Kandhari:
was G.3.5
Kuljit
Kandhari:
was G.3.3.4
was
G.3.4
Kuljit
Kandhari:
was G.3.3.3
Kuljit Kandhari:
was G.3.3.2
D.2.6.1
D.2.6.1
D.2.6.1.1
D.2.6.1.1
D.2.6.1.2
D.2.6.1.2
Kuljit Kandhari:
Kuljit Kandhari:
Was G.3.2.3
was
G.3.3.1
Kuljit
Kandhari:
was G.3.3
Kuljit Kandhari:
Was G.3.2.2
Kuljit Kandhari:
Was G.3.2.1
SA fromKuljit
CHMP
Kandhari:
Was G.3.2
If 'Yes' to D.2.6., Please

indicate the source of
advice and provide a
copy in the CTA
request:
From the CHMP?
SA fromKuljit
NCAKandhari: From a National
Was G.3.1
Competent Authority?
Kuljit Kandhari:
Was G.3.2.1
Kuljit Kandhari:
Was G.3.2
Kuljit Kandhari:
Was G.3.1
D
D
D.3
D.3.1
D.3
D.3.1
IMP Description
IMP Name
Description of the IMP

Product name where
applicable
Kuljit
Kuljit K
K
This
is G
Is G.1.5
Annex
CTA ForC
D.3.2
D.3.2
IMP Code
Product code where

applicable
D.3.3
D.3.3
IMP ATC Code
ATC codes if officially

registered (enter up to
5):
D.3.4
D.3.4
IMP Pharmaceutical
Form
Pharmaceutical form
N/A
N/A
Sponsor generated ATC

code
New
D.3.4.1
Specific paediatric
formulation
Is this a specific
paediatric formulation?
D.3.5
New
D.3.5
Maximum duration of
treatment
Maximum duration of
treatment of a subject
according to the
protocol
D.3.6
Dose allowed
Dose allowed
D.3.6.1
First dose in FIH dose

allowed
First dose for first-inhuman clinical trial
Kuljit Kandhari:
Previous feld was
EUTCT ID which is not
required.
Neil Cordwell:
Was: Population specifc
vunerable populations
New
D.3.6.1
First dose in FIH Dose

per Day or Total
Specify per day or total
New
D.3.6.1
First dose in FIH Total

Dose Number
Specify total dose

(number):
New
D.3.6.1
New
D.3.6.1
First dose in FIH Total

Dose Unit
First dose in FIH RoA
Specify total dose (unit):
D.3.6
D.3.6.2
Maximum dose allowed Maximum dose allowed
D.3.6
D.3.6.2
Maximum dose per Day Specify per day or total

or Total
D.3.6
D.3.6.2
Maximum dose Total

Dose Number
Specify total dose

(number and unit):
D.3.6
D.3.6.2
Maximum dose Total

Dose Unit
Specify total dose

(number and unit):
D.3.6
D.3.6.2
Maximum dose RoA
Route of administration
(relevant to the
maximum dose):
(relevant to the first
dose):
D.3.7
D.3.7
D.3.8 to D.3.10
D.3.8 to
D.3.10
IMP Routes of
Administration
Routes of administration
for this IMP
IMP Identification
Details (Active
Substances)
D.3.8
D.3.8
AS INN
INN - Proposed INN
D.3.9
D.3.9.1
AS CAS number
CAS number
D.3.9
D.3.9.2
AS current sponsor
code
Current sponsor code
D.3.9
D.3.9.3
AS other descriptive
name
Other descriptive name
Not displayed
D3.9.4
EV Substance Code
EV Substance Code
New
D.3.9.5
AS molecular formula
Full Molecular formula
New
D.3.9.6
AS description
Chemical/biological
description of the Active
Substance
D.3.10
D.3.10
Strength
Strength
D.3.10.1
D.3.10.1
AS Concentration unit
Concentration unit
D.3.10.2
D.3.10.2
AS Concentration type
Concentration type
D.3.10.3
D.3.10.3
AS Conc num 1
Concentration number
(only use both fields for
range)
D.3.10.3
D.3.10.3
AS Conc num 2
(only use both fields for
range)
D
D
D
D.3.11
D.3.11
D.3.11
D.3.11
D.3.11.1
D.3.11.1
End of active substances within the product Repeating Group

Type of IMP
Does the IMP contain
an active substance of:
Chemical origin AS
Of chemical origin?
D.3.11.2
D.3.11.2
Biological origin AS
Of biological/
biotechnological origin
(other than Advanced
Therapy IMP (ATIMP)?
Is this IMP a:
New
D.3.11.3
Advanced Therapy MP
Advanced Therapy IMP

(ATIMP)
D.3.11.3
D.3.11.3.1
Somatic cell therapy MP Somatic cell therapy

medicinal product?
D.3.11.4
D.3.11.3.2
Gene therapy MP
gene therapy medical

product?
New
D.3.11.3.3
Tissue Engineered MP
New
D.3.11.3.4
Combination ATIMP
Tissue Engineered
Product?
Combination ATIMP (i.e.
one involving a medical
device)?
New
D.3.11.3.5
CAT Classification
issued
New
D.3.11.3.5.1 CAT Classification
If yes, please provide

that classification and
its reference number
New
D.3.11.4
Combination product
including device
Combination product
that includes a device,
but does not involve an
Advanced Therapy
D.3.11.5
D.3.11.5
Radiopharmaceutical
MP
radiopharmaceutical
medicinal product?
D.3.11.6
D.3.11.6
Immunological MP
immunological
medicinal product (such
as vaccine, allergen,
immune serum)?
D.3.11.7
D.3.11.7
Plasma derived MP
plasma derived
medicinal product?
D.3.11.8
D.3.11.8
Extractive MP
Extractive medicinal
product?
Has the Committee on

Advanced therapies
issued a classification
for this product?
New
D.3.11.9
Recombinant MP
Recombinant medicinal
product?
D.3.11.11
D.3.11.10
GMO MP
medicinal product
containing genetically
modified organisms?
If 'Yes', has the

authorisation for
contained use or
release been granted?
D.3.11.11.1
D.3.11.10.1
GMO MP Auth granted
granted?
D.3.11.11.2
D.3.11.10.2
GMO MP Auth pending or is it pending?
D.3.11.9
D.3.11.11
Herbal MP
Herbal medicinal
product?
D.3.11.10
D.3.11.12
Homeopathic MP
Homeopathic medicinal
product?
D.3.11.12
D.3.11.13
Other MP
Another type of
medicinal product?
D.3.11.12.1
D.3.11.13.1
Other MP Specification
If 'another type of
medicinal product'
specify the type of
medicinal product
New
D.3.12
Mode of action
Specify the mode of

action for the active
substance in this
medicinal product
New
D.3.13
First in Human
Is it an IMP to be used
in a first-in-human
clinical trial?
New
D.3.13.1
First in Human Risk

Factors
If yes, are there risk

factors identified,
according to the
guidance FIH
D.4.1
D.4.1
Type of product
D.4.1.1
Replaced by Extractive IMP

D.3.11.8
Extractive
D.4.1.2
Replaced by Recombinant IMP

D.3.11.9
Recombinant
D.4.1.3
Replaced by Vaccine IMP

D.3.11.6
Vaccine
D.4.1.4
Replaced by GMO IMP

D.3.11.12
GMO
D.4.1.5
Replaced by Plasma Derived IMP

D.3.11.7
Plasma derived
products
D.4.1.6
Replaced by Other IMP

D.3.11.13
Others
D.4.1.6.1
Removed
Other IMP Specification If others, specify:
D.5
D.4
Somatic Cell Therapy

IMP

Investigational
Medicinal Product (No
Genetic Modification)
D.5.1
D.4.1
Origin of cells
D.5.1.1
D.4.1.1

Origin
origin autologous
D.5.1.2
D.4.1.2

origin allogeneic
Allogeneic
D.5.1.3
D.4.1.3

origin xenogeneic
Xenogeneic
Autologous
D.5.1.3.1
D.4.1.3.1

xenogeneic species
If 'xenogeneic', specify
the species of origin
D.5.2
D.4.2
Type of cells
D.5.2.1
D.4.2.1

Type
type stem
D.5.2.2
D.4.2.2

type differentiated
Differentiated cells
D.5.2.2.1
D.4.2.2.1
Type of differentiated
cells
If 'differentiated', specify
the type of cells (e.g.
keratinocytes,
fibroblasts,
chondrocytes...)
D.5.2.3
D.4.2.3

type other
Others
D.5.2.3.1
D.4.2.3.1

type other specification
If 'others', specify the

type of cells
D.6
D.5
Gene Therapy IMP
Gene Therapy
Investigational
Medicinal Product
D.6.1
D.5.1
Gene therapy gene(s)

of interest
Gene(s) of interest
D.6.2
D.5.2
Gene therapy in-vivo
D.6.3
D.5.3
Gene therapy ex-vivo
Is this 'in vivo' gene

therapy?
Is this 'ex vivo' gene
therapy?
D.6.4
D.5.4
D.6.4.1
D.5.4.1
Gene therapy nucleic

acid
Stem cells
Type of gene transfer

product
Nucleic acid (e.g.
plasmid)
D.6.4.1.1
D.5.4.1.1
Gene therapy naked
naked
D.6.4.1.2
D.5.4.1.2
Gene therapy
complexed
complexed
D.6.4.2
D.5.4.2
Gene therapy viral

vector
Viral vector
D.6.4.2.1
D.5.4.2.1
Gene therapy viral

vector type
If yes, specify the type

(adenovirus, retrovirus,
AAV...)
D.6.4.3
D.5.4.3
Gene Therapy other
Others
D.6.4.3.1
D.5.4.3.1
Gene therapy other

specification

type of gene transfer
product
D.6.5
D.5.5
GM cells
Does the IMP contain

genetically modified
cells?
GM cells origin
If yes, specify the origin

of the cells:
Autologous
D
D
D.6.5.1
D.5.5.1
GM cells origin
autologous
D.6.5.2
D.5.5.2
GM cells origin
allogeneic
Allogeneic
D.6.5.3
D.5.5.3
GM cells origin
xenogeneic
Xenogeneic
D.6.5.3.1
D.5.5.3.1
GM cells xenogeneic
species
If yes, specify the

species of origin
D.6.5.4
Removed in GM cells Other

V8
Other type of cells
D.6.5.4
D.5.5.4
Specify type of cells

(hematopoietic stem
cells)
D.6.6
Removed in Novel Gene comments

V8
GM cells Other
specification
New
D.6
Tissue Engineered
Product
Tissue Engineered
Product
New
D.6.1
Origin of cells
New
D.6.1.1
Tissue Engineered
origin
Tissue Engineered
origin autologous
New
D.6.1.2
Allogeneic
New
D.6.1.3
New
D.6.1.3.1
Tissue Engineered
origin allogeneic
Tissue Engineered
origin xenogeneic
Tissue Engineered
xenogeneic species
D
D
New
New
D.6.2
D.6.2.1
New
D.6.2.2
New
D.6.2.2.1
Tissue Engineered
differentiated
specification
If 'differentiated', specify
the type of cells (e.g.
keratinocytes,
fibroblasts,
chondrocytes...)
New
D.6.2.3
Tissue Engineered
Other
Others
New
D.6.2.3.1
New
D.7
Tissue Engineered
Other specification
Products containing
devices

type of cells
Products containing
devices (i.e. Medical
Devices, scaffolds, etc.)
New
D.7.1
Device description
Give a brief description

of the device
New
D.7.2
Device name
What is the name of the

device?
New
D.7.3
Device implantable
New
D.7.4
New
D.7.4.1
Is the device
implantable?
Does this product
contain:
A medical device?
Autologous
Xenogeneic
If yes, specify the
species of origin
Type of cells
Tissue Engineered type Stem cells
stem
Tissue Engineered type Differentiated cells
differentiated
Contains medical
device
New
D.7.4.1.1
Device has CE mark
Does this medical

device have a CE
mark?
New
D.7.4.1.1.1
Device notified body
The notified body is:
New
D.7.4.2
Contains Bio-materials
Bio-materials?
New
D.7.4.3
Contains Scaffolds
Scaffolds?
New
D.7.4.4
Contains Matrices
Matrices?
New
D.7.4.5
Device Other
Other?
New
D.7.4.5.1
Device Other
specification
If 'other', specify:
D.8
D.8
D.7
D.8
Placebo Repeating group rows

Information on Placebo
D.8
D.7.1
D.8.1
Trial has placebo
D.8
D.7
D.8
D.8
D.7.2
D.8.2
D.8
D.7.3
D.8.3
D.8
D.7.4
D.8.4
D.8
D.8
D.7.5
D.8.5
D.8
D.7.5
D.8.5
Which IMP(s) is it a
placebo for? Specify
IMP number(s) from
D.1.1
D.8
D.7.5.1
D.8.5.1
Composition, apart from

the active substance(s):
Is there a placebo?
Placebo sequence
number
Placebo Pharmaceutical Pharmaceutical form
form
Placebo Route of
administration
Repeating group of products for which this is the placebo rows

Related IMP sequence
number
D.8
D.7.5.2
D.8.5.2
Placebo identical to IMP Is it otherwise identical

to the IMP?
D.8
D.7.5.2.1
D.8.5.2.1
Placebo major
ingredients
D.9
D.8
D.9
D.9
D.9
D.8.1
D.9.1
D.9.1
IMPs and Placebos for which no Responsible Site needs to be identified

Conditions Met?
If all the conditions
above are met, then tick
this box and select
below the IMPs and
placebos to which this
applies.
D.9
D.9.3
IMP sequence number
Finished IMP {Product

seq no.}
D.9
D.9.4
Placebo sequence
number
Finished IMP {Product

seq no.}
D.9
D.9
D.9
D.8.2
D.9.2
D.8.2.1 and
D.8.2.2
D.9.2.1 and
D.9.2.2
If composition is not
otherwise identical,
specify the major
ingredients
Site(s) where the
qualified person
certifies batch release
Responsible sites Repeating group

Responsible site
Who is responsible in
the Community for the
certification of the
finished IMPs?
Responsible Site Role
As a manufacturer,
importer or both?
D.9
D.8.2.3
D.9.2.3
Responsible Site
Organisation
D.9
D.8.2
D.9.2.4
D.9
D.8.2.3.1
D.9.2.4.1
Responsible Site
Address
Address
Responsible Site Street Street address
Address
D.9
D.8.2.3.1
D.9.2.4.2
Responsible Site
Town/City
Town/ city
D.9
D.8.2.3.1
D.9.2.4.3
Responsible Site Post

Code
Post code
D.9
D.8.2.3.1
D.9.2.4.4
Responsible Site
Country
Country
D.9
D.8.2.4
D.9.2.5
Manufacturer
authorisation number
Manufacturer
authorisation number
D.9
D.8.2.4.1
D.9.2.5.1
Reason for no
authorisation
If no authorisation, give
the reasons
D.9
D.9
D.8.2
D.9.2
D.9
D.8.2
D.9.2
D.9
D.9
Site organisation name
Repeating group of products for which this is the responsible site

Product sequence
number
Placebo sequence
number
End of repeating group of products for which this is the responsible site
End of responsible sites Repeating group
E. General
Informatio
n on the
Trial
E.1
E.1
E.1.1
E.1.1
Medical condition
New
E.1.1.1
Medical condition in lay Medical condition in

language
easily understood
language
New
E.1.1.2
Therapeutic area
Medical condition or
disease under
investigation.
Repeating group for

MedDRA codes
Specify the medical

condition(s) to be
investigated (free text)
Identify the therapeutic

area
E.1.2
E.1.2
E.1.2
E.1.2
MedDRA Version
Version
E.1.2
E.1.2
MedDRA Level
Level
E.1.2
E.1.2
MedDRA Code
Classification code
E.1.2
E.1.2
MedDRA Term
Term
E.1.2
E.1.2
MedDRA System Organ SOC

Class
End Repeating group
for MedDRA codes rows
E.1.3
E.1.3
Condition a rare
disease
MedDRA information
Is any of the conditions

being studied a rare
disease?
E
E
E.2
E.2.1
E.2
E.2.1
Trial Objective
Trial main objective
Objective of the trial

Main objective of the
trial
E.2.2
E.2.2
Trial secondary
objective
Secondary objectives of
the trial
E.2.3
E.2.3
Has a sub-study
Is there a sub-study?:
E.2.3.1
E.2.3.1
Sub-study details
If Yes give the full title,

date and version of
each sub-study and
their related objectives
E
E.3 Principal Inclusion
Criteria, E.4 Principal
Exclusion Criteria and
E.5 End point(s)
E.3
E.3
Principal inclusion
criteria
Principal inclusion
criteria (list the most
important, max 5000
characters)
E.4
E.4
Principal exclusion
criteria
Principal exclusion
criteria (list the most
important, max 5000
characters)
E
E
E.5
E.5.1
E.5
E.5.1
End points
Primary end points
End points
Administrator:
Primary
end "Note:
point(s)
Alert Flag:
for Trials loaded in the system before
(max
characters)
the 5000
10th March
2011 this question read: Women of
childbearing potential and did not include the words no

using contraception. The answer should therefore be
understood in that context, depending on when the
information was entered in the system (see start date)
that appears on the query returned page."
New
E.5.1.1
Primary end point

timepoint
Timepoint(s) of
evaluation of this end
point
New
E.5.2
Secondary end point
Secondary end point(s)

(max 5000 characters)
New
E.5.2.1
Secondary end point

timepoint
Timepoint(s) of
evaluation of this end
point
E.6 and E.7
E.6 and E.7
Scope of the Trial, Trial

Type and Phase
E.6
E.6
Trial scope
Scope of the trial
E.6.1
E.6.1
Trial scope Diagnosis
Diagnosis
E.6.2
E.6.2
Trial scope Prophylaxis Prophylaxis
E.6.3
E.6.3
Trial scope Therapy
Therapy
E.6.4
E.6.4
Trial scope Safety
Safety
E.6.5
E.6.5
Trial scope Efficacy
Efficacy
E.6.6
E.6.6
Pharmacokinetic
E.6.7
E.6.7
Trial scope
Pharmacokinetic
Trial scope
Pharmacodynamic
E.6.8
E.6.8
Trial scope
Bioequivalence
Bioequivalence
E.6.9
E.6.9
Dose response
E.6.10
E.6.10
E.6.11
E.6.11
Trial scope Dose

response
Trial scope
Pharmacogenetic
Trial scope
Pharmacogenomic
E.6.12
E.6.12
Trial scope
Pharmacoeconomic
Pharmacoeconomic
E.6.13
E.6.13
Trial scope Other
Others
E.6.13.1
E.6.13.1
Trial scope Other

specification
If 'others', specify scope

of the trial
Pharmacodynamic
Pharmacogenetic
Pharmacogenomic
E.7
E.7
Trial Type
Trial type and phase
E.7.1
E.7.1
Trial type Human

Human pharmacology
pharmacology (Phase I) (Phase I)
E.7.1.1
E.7.1.1
Trial type First

administration to
humans
First administration to
humans
E.7.1.2
E.7.1.2
Trial type
Bioequivalence Study
Bioequivalence study
E.7.1.3
E.7.1.3
Trial type Other
Other
E.7.1.3.1
E.7.1.3.1
Trial type Other

specification
If 'other', specify trial

type
E.7.2
E.7.2
Trial type Therapeutic

Exploratory (Phase II)
Therapeutic exploratory
(Phase II)
E.7.3
E.7.3

Therapeutic
Confirmatory (Phase III) confirmatory (Phase III)
E.7.4
E.7.4

Use (Phase IV)
Therapeutic use (Phase

IV)
E.8
E.8
Trial Design
Design of the trial
E.8.1
E.8.1
Trial design controlled
Controlled
E.8.1.1
E.8.1.1
Trial design randomised Randomised
E.8.1.2
E.8.1.2
Trial design Open
E.8.1.3
E.8.1.3
Trial design Single blind Single blind
E.8.1.4
E.8.1.4
Trial design Double

blind
Double blind
E.8.1.5
E.8.1.5
Trial design Parallel

group
Parallel group
E.8.1.6
E.8.1.6
Trial design Cross-over Cross over
Open
E.8.1.7
E.8.1.7
Trial design Other
Other
E.8.1.7.1
E.8.1.7.1
Trial design Other

specification
If 'other', specify the

design of the trial
E.8.2
E.8.2
Comparator
If controlled, specify the

comparator:
E.8.2.1
E.8.2.1
Comparator another MP Other medicinal

product(s)
E.8.2.2
E.8.2.2
Comparator a placebo
Placebo
E.8.2.3
E.8.2.3
Other comparator
Other
E.8.2.3.1
E.8.2.3.1
Other comparator
specification
If 'other', specify the

comparator
New
E.8.2.4
Number Treatment
Arms
Number of treatment
arms in the trial
E.8.3
E.8.3
Single site trial
Single site in the

Member State
concerned (see also
Section G)
E.8.4
E.8.4
Multiple site trial
Multiple sites in the

Member State
concerned (see also
Section G)
E.8.4.1
E.8.4.1
Number of sites in MS
Number of sites
anticipated in Member
State concerned
E.8.5
E.8.5
E.8.5.1
E.8.5.1
Trial involving multiple Multiple Member States

MS
Number of sites in EEA Number of sites
anticipated in the EEA
New
E.8.6
E.8.6
E.8.6.1
Trial involves 3rd

countries
New
E.8.6.2
Trial conducted
Trial being conducted
completely outside EEA completely outside of
the EEA
New
E.8.6.3
Planned countries
If E.8.6.1 or E.8.6.2 are

yes, specify the
countries in which trial
sites are planned
New
E.8.6.4
Number of sites worldwide
If E.8.6.1 or E.8.6.2 are

yes, specify the number
of sites anticipated
outside of the EEA
E.8.7
E.8.7
Trial has independent

data monitoring
committee
Trial having a data

monitoring committee?
E.8.8
E.8.8
End of trial definition
Definition of the end of

the trial and justification
in the case where it is
not the last visit of the
last subject undergoing
the trial
Trial involving sites

outside the EEA
both within and outside
the EEA
E.8.9
E.8.9
Estimated trial duration
Initial estimate of the

duration of the trial
(years, months and
days)
E.8.9.1
E.8.9.1

in MS years
In the Member State

concerned
years
E.8.9.1
E.8.9.1

in MS months
In the Member State

concerned
months
E.8.9.1
E.8.9.1

in MS days
In the Member State

concerned
days
E.8.9.2
E.8.9.2

worldwide years
In all countries
concerned by the trial
years
E.8.9.2
E.8.9.2

worldwide months
In all countries
months
E.8.9.2
E.8.9.2

worldwide days
In all countries
days
New
E.8.10
Recruitment start date
Proposed date of start of
New
E.8.10.1

in MS
In the Member State

concerned
New
E.8.10.2

in any country
In any country
F.
Population
of Trial
Subjects
Population of trial
subject
F.1
F.1
Age Range
Age Range
F.1.1
F.1.1
Population under
eighteen
Are the trial subjects

under 18?
New
F.1.1
Population number
under eighteen
Number of subjects for

this age range:
F.1.1.1
F.1.1.1
Population in utero
In Utero
New
F.1.1.1.1
Population number in
utero

this age range:
F.1.1.2
F.1.1.2
Population preterm
newborn infants
Preterm newborn
infants (up to
gestational age < 37
weeks)
New
F.1.1.2.1
Population number
preterm newborn infants this age range:
F.1.1.3
F.1.1.3
Population newborns
Newborns (0-27 days)
New
F.1.1.3.1
Population number
newborns

this age range:
F.1.1.4
F.1.1.4
Population infants and

toddlers
Infants and toddlers (28

days-23 months)
New
F.1.1.4.1
Population number
infants and toddlers

this age range:
F.1.1.5
F.1.1.5
Population children
Children (2-11years)
New
F.1.1.5.1
Population number
children

this age range:
F.1.1.6
F.1.1.6
Population adolescents Adolescents (12-17

years)
New
F.1.1.6.1
Population number
adolescents

this age range:
F.1.2
F.1.2
Population adults
Adults (18-64 years)
New
F.1.2.1
Population number
adults

this age range:
F.1.3
F.1.3
Population elderly
Elderly (>=65 years)
New
F.1.3.1
Population number
elderly

this age range:
F
F
F.2
F.2.1
F.2
F.2.1
Gender
Population female
Gender
Female
F.2.2
F.2.2
Population male
Male
F
F
F.3
F.3.1
F.3
F.3.1
Group of trial subjects

Population healthy
volunteers

Healthy volunteers
F.3.2
F.3.2
Population patients
Patients
F.3.3
F.3.3
Population specific
vulnerable populations
Specific vulnerable
populations
F.3.3.1
F.3.3.1
Population women of
child bearing potential
no contraception
women of childbearing
potential not using
contraception
F.3.3.2
F.3.3.2
Population women of
child bearing potential
contraception
women of child-bearing
potential using
contraception
F.3.3.3
F.3.3.3
Population pregnant
women
pregnant women
F.3.3.4
F.3.3.4
Population nursing
women
nursing women
F.3.3.5
F.3.3.5
Population emergency
situation
emergency situation
F.3.3.6
F.3.3.6
Population subjects
incapable of giving
consent
subjects incapable of
giving consent
personally?
F.3.3.6.1
F.3.3.6.1
Population subjects
incapable of giving
consent details
If 'Yes', specify
F.3.3.7
F.3.3.7
Population other
subjects
others
F.3.3.7.1
F.3.3.7.1
Population other
subjects details

specific vulnerable
populations
F.4
F.4
Population planned
numbers
Planned number of
subjects to be included
F.4.1
F.4.1
Population planned
numbers in MS
In the member state
F.4.2
F.4.2
F.4.2.1
F.4.2.1
Population planned
numbers in EEA
In the EEA
F.4.2.2
F.4.2.2
Population planned
numbers in whole trial
In the whole clinical trial
F.5
F.5
Population post trial

treatment details
Plans for treatment or

care after the subject
has ended the
participation in the trial
(if it is different from the
expected normal
treatment of that
condition)
For a multinational trial
Investigator information. Repeat group
G. Clinical
Trial
Sites/Inves
tigators in
G.1
the/ G.2
Member
State
G.1 / G.2
Investigator details
Investigator sequence
number
Investigator role
G
G
G.1 / G.2
G.1 / G.2
G.1.1 / G.2.1
G.1.1 / G.2.1 Investigator Given

Name
G.1 and G.2

Investigator Details
What is the role of this

investigator?
Given name
G.1.2 / G.2.2
G.1.2 / G.2.2 Investigator Middle

name
Middle name
G.1.3 / G.2.3
G.1.3 / G.2.3 Investigator Family

Name
Family name
G.1.4 / G.2.4
G.1.4 / G.2.4 Investigator

qualifications
Qualification (MD...)
G.1.5 / G.2.5
G.1.5 / G.2.5 Institution details
Professional address
G.1.5 / G.2.5
Institution name
G.1.5 / G.2.5
G.1.5 / G.2.5
G.1.5 / G.2.5
G.1.5 / G.2.5
G.1.5 / G.2.5
G.1.5 / G.2.5 Investigator Institution

Name
G.1.5 / G.2.5 Investigator Institution
Department
G.1.5.1 /
Investigator Street
G.2.5.1
Address
G.1.5.2 /
Investigator Town/City
G.2.5.2
G.1.5.3 /
Investigator Post Code
G.2.5.3
G.1.5.4 /
Investigator Country
G.2.5.4
G.1.7 / G.2.7
G.1.6 / G.2.6 Investigator Telephone
Telephone number
New
G.1.7 / G.2.7 Investigator Fax
Fax number
G.1.6 / G.2.6
G.1.8 / G.2.8 Investigator Email
E-mail
G.3
G.3
CTF Organisation
Details
G.3 Central Technical

Facility Details
G.3.1
G.3.1
CTF Organisation
Institution department
name
Street address
Town/city
Post code
Country
G.3.1
G.3.2
CTF Department
Central technical facility

organisation department
G.3.2
G.3.3
CTF Contact Details
G.3.2
G.3.3.1
CTF Given Name
Given name
G.3.2
G.3.3.2
CTF Middle name
Middle name
G.3.2
G.3.3.3
CTF Family Name
Family name
G
G
G.3.3
G.3.3
G.3.4
G.3.4.1
CTF Address
CTF Street Address
Address
Street address
G.3.3
G.3.4.2
CTF Town/City
Town/ city
G.3.3
G.3.4.3
CTF Post Code
Post code
G.3.3
G.3.4.4
CTF Country
Country
G.3.4
G.3.5
CTF Telephone
Telephone number
New
G.3.6
CTF Fax
Fax number
New
G.3.7
CTF Email
E-mail
G.3.5
G.3.8
CTF duties
Enter the details of any

duties subcontracted to
this central technical
facility in this trial
G.3.5
G.3.8.1
CTF duties routine

clinical pathology
Routine clinical
pathology testing
G.3.5
G.3.8.2
CTF duties clinical

chemistry
Clinical chemistry
G.3.5
G.3.8.3
CTF duties clinical

haematology
Clinical haematology
G.3.5
G.3.8.4
CTF duties clinical

microbiology
Clinical microbiology
G.3.5
G.3.8.5
CTF duties
histopathology
Histopathology
G.3.5
G.3.8.6
CTF duties serology

endocrinology
Serology/ endocrinology
G.3.5
G.3.8.7
CTF duties analytical

chemistry
Analytical chemistry
G.3.5
G.3.8.8
CTF duties ECG

analysis
ECG analysis/ review
G.3.5
G.3.8.9
CTF duties medical

image analysis
Medical image analysis/

review - X-ray, MRI,
ultrasound, etc.
G.3.5
G.3.8.10
CTF duties endpoint

test
Primary/ surrogate
endpoint test
G.3.5
G.3.8.11
CTF duties others
Other Duties
subcontracted?
G.3.5
G.3.8.11.1
CTF duties others

description
If 'Yes', specify the other

duties
G
G
New
G.4
Technical Facility information End repeating group

Network organisation
Networks to be involved
details
in the Trial
New
G.4.1
Network Organisation
New
G.4.2
Network contact details Name of contact person
New
G.4.2.1
Network Given Name
Given name
New
G.4.2.2
Network Middle Name
Middle name
New
G.4.2.3
Network Family Name
Family name
G
G
New
New
G.4.3
G.4.3.1
Network Address
Address
Network Street Address Street address
New
G.4.3.2
Network Town/City
Town/ city
New
G.4.3.3
Network Post Code
Post code
New
G.4.3.4
Network Country
Country
New
G.4.4
Network Telephone
Telephone number
New
G.4.5
Network Fax
Fax number
New
G.4.6
Network Email
E-mail
New
G.4.7
Network Activities
Activities carried out by

the network
G
G
G.4
G.5
Sponsors duties and functions subcontracted facility information Repeatin

Trial Monitoring Facility Organisations to whom
details
the sponsor has
transferred trial related
duties and functions
G.5.1
Enter the details if the

sponsor has transferred
any major or all the
sponsors trial related
duties and functions to
another organisation or
third party.
Enter the details if the

sponsor has transferred
any major or all the
sponsors trial related
duties and functions to
another organisation or
third party.
G.4.1.1
G.5.1.1
Subcontractor
Organisation Name
Organisation name
G.4.1.1
G.5.1.2
Subcontractor
Department Name
Organisation
department
G.4.1
G.5.1.3
G.4.1.2
G.5.1.3.1
Trial Monitoring Facility

contact details
Subcontractor Given
Name
G.4.1.2
G.5.1.3.2
Subcontractor Middle
name
Middle name
G.4.1.2
G.5.1.3.3
Subcontractor Family
Name
Family name
G
G
G.4.1.3
G.4.1.3
G.5.1.4
G.5.1.4.1
Subcontractor Address
Subcontractor Street
Address
Address
Street address
G.4.1.3
G.5.1.4.2
Subcontractor Town/City Town/ city
G.4.1.3
G.5.1.4.3
Subcontractor Post
Code
Post code
G.4.1.3
G.5.1.4.4
Subcontractor Country
Country
G.4.1.4
G.5.1.5
Subcontractor
Telephone
Telephone number
Given name
New
G.5.1.6
Subcontractor Fax
Fax number
New
G.5.1.7
Subcontractor Email
E-mail
Enter the details of any

duties/ functions
subcontracted to this
sponsor's subcontractor
facility in this trial
G.4.1.5
G.5.1.8
Subcontractor duties all All tasks of the sponsor

sponsor tasks
G.4.1.6
G.5.1.9
Subcontractor duties
monitoring
Monitoring
G.4.1.7
G.5.1.10
regulatory
Regulatory (e.g.
preparation of
applications to CA and
Ethics Committee)
G.4.1.8
G.5.1.11
Investigator recruitment
investigator recruitment
G.4.1.9
G.5.1.12
IVRS treatment
IVRS - treatment
randomisation
G.4.1.10
G.5.1.13
data management
Data Management
G.4.1.11
G.5.1.14
edata capture
E-data capture
G.4.1.12
G.5.1.15
SUSAR reporting
SUSAR reporting
G.4.1.13
G.5.1.16
quality assurance
auditing
Quality assurance
auditing
G.4.1.14
G.5.1.17
statistical analysis
Statistical analysis
G.4.1.15
G.5.1.18
medical writing
Medical writing
G.4.1.16
G.5.1.19
others
Other Duties
subcontracted?
G.4.1.16.1
G.5.1.19.1
others description
If 'Yes', specify the other

duties
H.
Competent
Authority/E
thics
Committee
This section records

the Competent
Authority Information
for transmission to the
Competent Authority
H.2.1
H.2.1
NCA Organisation
National Competent
authority name
H
H
H.2.1
H.2.1
H.2.2
H.2.2.1
NCA Address
NCA Street Address
Address
Street address
H.2.1
H.2.2.2
NCA Town/City
Town/ city
H.2.1
H.2.2.3
NCA Post Code
Post code
H.2.1
H.2.2.4
NCA Country
Country
H.2.2
H.2.3
NCA Submission date
Date of submission
H
H
H.3
H.3.1 / H.3.2 /
H.3.3
H.3
H.3.1 / H.3.2 NCA Authorisation
/ H.3.3
status
H.3.3.1
H.3.3.1
H
H
H.3.3.2 / H.3.3.3 H.3.3.2 /

H.3.3.3
Authorisation/Opinion
What is the status of the
National Competent
Authority's
authorisation?
If 'Given' specify:
NCA Authorisation date Date of authorisation
NCA Authorisation
Acceptance
Indicate whether
accepted or not
H.3.3.3.1
H.3.3.3.1
NCA Authorisation not

accepted reasons
If 'not accepted', give

the reasons
H.3.3.3.2
H.3.3.3.2
NCA Anticipated
resubmission date
If 'not accepted', give

the eventual anticipated
date of resubmission
H
H
H.2.1
H.2.1
This section records the Ethics Committee Information for transmission to

IEC Organisation
Ethics committee name
H
H
H.2.1
H.2.1
H.2.2
H.2.2.1
IEC Address
IEC Street Address
Address
Street address
H.2.1
H.2.2.2
IEC Town/City
Town/ city
H.2.1
H.2.2.3
IEC Post Code
Post code
H.2.1
H.2.2.4
IEC Country
Country
H.2.2
H.2.3
IEC Submission date
Date of submission
H
H
H.3
H.3.1 / H.3.2 /
H.3.3
H.3
H.3.1 / H.3.2 IEC Opinion Status
/ H.3.3
H
H
H.3.3.1
H.3.3.1
IEC Opinion date
Authorisation/Opinion
What is the status of the
Ethics Committee's
opinion?
If 'Given' specify:
Specify the date of
opinion
H.3.3.2 / H.3.3.3 H.3.3.2 /

H.3.3.3
IEC Opinion Given
Indicate whether
favourable or not
H.3.3.3.1
H.3.3.3.1
IEC Opinion not

favourable reasons
If 'not favourable', give

the reasons
H.3.3.3.2
H.3.3.3.2
IEC Anticipated
resubmission date
If 'not favourable', give

the eventual anticipated
date of resubmission
H.4
Third Country in which

the trial was first
authorised:
First Authorised 3rd
Country
Third Country in which

the trial was first
authorised:
New
H.4.1
I
I
I
I
I
I
I.1
I.1
I.2
I.2
I.2.1
I.2.2
I.2.3
I.2.1
I.2.2
I.2.3
I.3
I.3
Applicant of the
request for the Ethics
Committee (as stated
in Section C.2):
I
I
I
I
I
I
I
J
L
L
L
I.3.1
I.3.2
I.3.3
I.3.1
I.3.2
I.3.3
New
New
New
New
J
L
L/C1
L/C1
I.4
L/C1
L/C1
Date
Signature
Print Name
PIP Addressee
Date
Signature
Print Name
The form Section J is a checklist of information to be appended to the pape
The form Section L is the applicant declaration page.
Applicant Organisation
Applicant contact
person Given Name
Applicant contact
person first name
N: This section records the information added to the database to Review t
N/A
(n_comment NCA comments

s)
Free text comments

field
N.
National clinical trial
(n_clinical_tri number
al_no)
National Clinical Trial

Number
I
I
N
N
I.4.1
I.4.2
I.4.3
J
L
L/C1
L/C1
Clinical trial has been

reviewed and given the
necessary approval(s)
by the Regulatory
Authority (where
required) and by the
The form Section I is theEthics
applicant
declaration page.
Committee(s).
Text relating to the declaration for signature below
Applicant of the request for the Competent Authority (as stated in Section C
Date
Signature
Print Name
N.
Application received
(n_date_rec date
eivedInputD
ate)
Date CT Application
Received
N.
Process start date
(n_date_star
tedInputDate
)
Date CT Process
Started
(n_review_g Request modified for

na)
GNA
Was the request to the

CA revised/modified
during the review
procedure in order to
respond to Grounds for
Non-Acceptance
(GNA)?
N.
GNA Reasons
(reasonstlco
ntentBox)
If Grounds for NonAcceptance (GNA), give

reasons
N.
GNA Reasons
(n_gna_addit Additional explanation
ional)
Additional explanation
regarding the reasons
N.
Sponsor protocol
(n_sp_amen amendment code
dment_code number
)
Sponsor's protocol
amendment code
number
N.
Sponsor protocol
(n_sp_amen amendment date
d_dateInput
Date)
Date of amendment
N.
Sponsor request
(sp_req_am amendment code
end_code)
number
Sponsor's request
amendment code
number
N.
Sponsor request
(n_sp_req_a amendment date
mend_dateI
nputDate)
Date of amendment
N.
NCA Decision
(n_auth_stat
us)
CA Authorisation/
Refusal/ Withdrawal of
the application
N.
NCA Decision Reasons If refused or withdrawn
(n_ca_revie
give reasons for CA
w_detailstlco
refusal / withdrawal
ntentBox)
N.
NCA Decision Reasons
(n_ca_revie Additional explanation
w_additional
)
If refused or withdrawn
provide additional
explanation regarding
the reasons
N.
NCA Decision date
(n_ca_dateI
nputDate)
Date of CA
Authorisation/ Refusal
or withdrawal of the
application
N.
IEC Opinion of
(n_iec_opini application
on_status)
IEC Opinion of the trial

application
N.
IEC Opinion Reasons
(n_iec_revie
w_detailstlco
ntentBox)
If an unfavourable
opinion or withdrawal,
give reasons for the
unfavourable opinion /
withdrawal
N.
IEC Opinion Reasons
(iec_review_ Additional explanation
additional)
If an unfavourable
opinion is given or there
is a withdrawal, provide
additional explanation
regarding the reason
N.
IEC Opinion date
(n_iec_dateI
nputDate)
Date of IEC Opinion or

withdrawal of the trial
application
N.
Separate IEC opinion
(n_iec_opini for GNA
on_separate
)
Was a separate IEC

opinion, on the
modification in response
to the CA's Grounds for
Non-Acceptance (GNA)
referred to above,
required due to the
relative timing of the CA
and IEC reviews?
If 'Yes' indicate the
opinion
N.
IEC opinion of
(n_iec_opini amendment
on_separate
_status)
IEC Opinion of
amendment referred
to ?
N.
IEC opinion of
(n_iec_opini amendment date
on_separate
_dateInputD
ate)
Date of IEC Opinion on

the modification referred
to above
This table lists the

data to be held in the
EudraCT database
that relates to
amendments.
(Detailed guidance on
the European clinical
trials database
Section O and part of
section N). The table
does not include the
information entered
on the Amendment
form but not added to
EudraCT.
The menu option
"Amendments" has a
red by it which
signifies core data set
information, but none
of the individual fields
are marked as such.
O.
Amendment type
(o_amendm
entType)
Type of amendment(*)
O.
Amendment code
(o_amendm number
entCodeNo)
Amendment code
number(*)
O.
Amendment Date
(o_amendm
entDateInput
Date)
Amendment Date
O.
Amendment received
(o_amendm date
entReceived
DateInputDa
te)
Date amendment
application received
O.
Amendment
(o_amendm assessment start date
entDateAsse
ssmentStart
edInputDate)
Date assessment
started
O.
Amendment IEC
(o_amendm opinion
entIECOpini
onStatus)
O.
Amendment IEC
(o_amendm opinion date
entIECOpini
onDateInput
Date)
O.
Amendment NCA
(o_amendm decision
entCaAuthSt
atus)
O.
Amendment NCA
(o_amendm decision date
entCaAuthSt
atusDateInp
utDate)
Date of IEC Opinion
Date of CA
Authorisation/ Refusal
Sponsor and contact

details of the E-O-T
Declaration are only
entered on the paper
form and are NOT
entered into EudraCT
or stored in the
database
The menu option "End
of Trial Data" has a
red by it which
signifies core data set
information, but none
of the individual fields
are marked as such.
P.
(trialSelect)
Trial Status
End of Trial Status
P.
Member State Trial End Is this the end of the

trial in this Member
State?
P. (N/A)
MS Trial End Date
If Yes enter the date of

the completion
P.
Global Trial End
(pX_trialAdd
EOTGlobal)
P.
Is this the end of the

trial globally?
Trial halt reason
P.
Other reason
(pX_trialAdd specification
SpecifyOther
Reason)
If Yes then please

specify the other
reason:
P.
Additional reasons
(pX_trialAdd
SponsorJusti
fication)
Briefly describe the

justification in the case
of a premature ending
of the trial
P.
Anticipated final clinical Anticipated date of final
(pX_trialAdd study report date
clinical study report
CSReportDa
teInputDate)
v8.1
Implementation
P.
Anticipated date of
results yyyy-mm-dd.
P.
Actual final clinical
(pX_trialAdd study report date
NCACSRep
ortDateInput
Date)
P.
NCA Comments
(pX_trialAdd
NCAComme
nts)
P.
Global Trial End date
(pX_trialAdd
EOTGlobalD
ateInputDate
)
Q
Q
Anticipated date of
results
Date of receipt of final

clinical study report by
the Competent Authority
If yes enter the date of

the global end of the
trial
Clinical Trial Site Inspection Data

Inspectorate
Q.
Member State carrying

out inspection
Q. (ins_id)
EudraCT Inspection ID
Q
Q
Q.
Inspection reference
(q_ref_no)
number
Q.
Inspection comments
(q_comment
s)
Inspection reference
number (*)
Inspection comments
Q. (q_status) Inspection status
Inspection status
Q.
Onsite inspection
(q_planned_ planned date
dateInputDat
e)
Planned date of on-site

inspection
Q.
Onsite inspection first
(q_first_dateI date
nputDate)
First date of on-site

inspection
Q.
Onsite inspection last
(q_last_dateI date
nputDate)
Last date of on-site

inspection
Q.
(q_site_org)
Q.
Site street address
(q_street_ad
dress)
Site street address
Q.
Site Town/City
Site Town/City
Q.
Site Postcode
(q_postcode)
Site Postcode
Q.
Site Country
Q.
Inspection Site Type
(q_site_type)
Site Country
EudraCT Inspection ID
Type of Site
Q.
Other type of site
(q_other_site
_type)
If 'other', specify type of

site
Inspection trial specific
Was this a trial specific

inspection?
Inspection system or
facility specific
Was this a system/

facility inspection?
If 'Yes' to either of the
previous two questions
provide additional
information below
Q.
Hospital
Hospital
Q.
Outpatient Clinic or GP
site
Outpatient clinic/ GP
site
Q.
Phase 1
(#q_is_phas
e_i)
Phase I
Q.
(#q_is_phas
e_i_beba)
Q.
(#q_is_analy
tical_lab_be
Q.
ba)
Phase 1 BE/BA
Phase I BE/ BA
Analytical Laboratory
BE/BA
Analytical laboratory BE/ BA
Analytical Lab
Analytical laboratory
Q.
Clinical Pathology Lab
Clinical pathology
laboratory
Q.
Technical Facility
Technical facility (ECG,

X-ray etc. analysis)
Q.
Data management
Data management,
analysis and reporting
Q.
Monitoring
Monitoring
Q.
SUSAR
(q_is_susar) Reporting/product
safety
Q.
e-CRF, patient diary,
(#q_is_ecrf) IVRS
SUSAR reporting/
product safety
Q.
Other
Q.
Other specification
(q_is_other_f
ac)
If 'other', specify type of

system/ facility
Q.
Was the inspection

triggered?
Q
Q
Other
Inspection triggered
e-CRF, patient diary,

IVRS
Q
Q
Q.
Inspection outcome
Inspection outcome
The EudraCT numbers and Sponsor Protocol Code Numbers may repeat.
Inspection EudraCT
EudraCT Number
number
Inspection Sponsor
Sponsor's protocol code
protocol code number
number
Q.
(eudract_no)
Q.
(sp_code_no
)
Q.
Inspection Sponsor
Organisation Name
Q.
Inspection Sponsor
(street_addr Street Address
ess)
Sponsor's Organisation
Name
Sponsor's Street
Address
Q.
Sponsor's Town/City
Q
Q
Inspection Sponsor
Town/City
Q.
Inspection Sponsor
(postcode)
Postcode
Q. (country) Inspection Sponsor
Country
Sponsor Postcode
Sponsor Country
End of repeating rows
Q
Q
Q
Repeating group to enter product affected by this inspection

NB. This product information is only shown in the guidance as required for
Q.
Inspection IMP trade
Trade name
(#trade_nam name
e)
Q.
Inspection IMP product
(#product_n name
ame)
End of products
repeating rows
Product name
Kandhari:
ames as shown in
chema
Comments
EU Help text
These are the details for section A. Trial

Identification. Enter details, then click 'Done'.
You can Copy/ Paste items of free text (e.g.
Protocol Title) from a word processing file of the
Protocol.
Calculated fields
Enter the name of the Member State (MS)
derived from Application concerned by the Application.
NCA country. Not stored
in the database.
The NCA organisation Select the concerned regulatory authority in the

that will be responsible Member State.
for entering the data to
the EudraCT database.
This information will be
used by the user access
security system to
ensure that NCAs can
only enter and edit
Applications for which
they have responsibility.
yyyy-nnnnnn-cc. yyyy =
year. nnnnnn is
sequential within year.
cc are check digits.
[AA and A1 are the
concatenated table key]
Obtained by the applicant through the EudraCT

public web site, this number should be the
same as the one mentioned on the receipt of
confirmation of EudraCT number. Note: In the
case of a resubmission (see section A.76), this
field should contain the same EudraCT number
as in the first submission.
Click in the free text field and enter the full title
of the clinical trial (up to 2000 characters). The
title should be identical to the one specified in
the study protocol and other documents
submitted as part of the Clinical Trial
Application dossier.
3rd country Help text
Title of the trial for lay

people, in easily
understood, i.e. nontechnical, language
Click in the free text field and enter the title of

the clinical trial in non-technical terms, suitable
for comprehension by individuals without
medical/pharmaceutical training (up to 2000
characters).
Name or abbreviated
title of the trial where
available
Click in the free text field and enter a shortened

title of the clinical trial, if one is available (up to
100 characters). This abbreviated title should
be identical to the one mentioned in the
protocol.
Sponsors protocol code Click in the free text field and enter the sponsor
number
protocol number, which is assigned by the
sponsor (up to 35 characters). This should be
identical to the protocol number provided when
the EudraCT number was obtained and which
appears on the receipt of confirmation of the
EudraCT number and should remain
unchanged throughout the study.The protocol
number should not contain any date or blanks
and should remain identical throughout the
duration of the clinical trial.
Sponsor's protocol
version
Click in the free text field and enter the sponsor

protocol version is assigned by the sponsor (up
to 10 characters). This should be identical to
that appearing in the protocol, though may
change according to any updates and
amendments to the final protocol. If none is
available, please leave blank.
Sponsor's protocol date Click the calendar to select the date of the
yyyy-mm-dd
protocol in the following format: YYYY-MM-DD.
The sponsor protocol date is assigned by the
sponsor and should be identical to that
appearing in the protocol. Any translation of the
protocol should be assigned the same date as
in the original document. This date may change
according to any updates and amendments to
the final protocol. However, the date included in
this form should always be the date of the
protocol which received the initial authorisation.
Any other updates on the protocol date should
only be provided in the corresponding
significant amendment form when applicable.
(reference: footnote 3 on page 16 of the
Commission Guidance on CT dossier for
competent authorities published 30th March
2010).
James Lenol:
This text duplicates that
already detailed in the
same named feld above
and cannot be included
due to feld id
implemantation. Nonissue in my estimation.
Incorrectly porposed for Enter the date of the last changed versions of
V8
the Sponsor's protocol in the following format:
YYYY-MM-DD. Alternatively, click the calendar
and select the start date.
Format
ISRCTN99999999
If the trial is registered on the Current

Controlled Trials web site
(http://www.controlled-trials.com/isrctn/ ),
please type the International Standard
Randomised Controlled Trial Number here.
James Lenol:
This text duplicates that
already detailed in the
same named feld above
and cannot be included
due to feld id
implemantation. Nonissue in my estimation.
Roughly, NCT numbers If the trial is registered on 'ClinicalTrials.gov',

are 8 digits, ascending please type the ClinicalTrials.gov identifier
and correlated with
(NCT number) here.
registration date.
More specifically,
NCT00000100 NCT00006520 are
sequential with
occasional random
gaps (caused by
deletions, errors, etc...)
then we got a little
smarter and started
incrementing by 13, so
NCT00006526 and after
are divisible by 13 which
means a one digit error
is noticed.
If the trial is registered on the WHO Clinical

Trials Portal, please type here the WHO
International Clinical Trials Registry Platform's
(ICTRP) registry number
(http://www.who.int/ictrp/unambiguous_identific
ation/utn/en/) where available.
Other Identifier - Name
If other identifiers are available click in the left

hand field and enter the name of the identifier,
then enter the identification number for this trial
in the right hand field. Click <img
title="Add New" alt="Add New" src="/eudractweb/img/add.png"> button to add additional
fields and click the <img
title="Remove" alt="Delete row" src="/eudractweb/img/delete.png"> button to delete fields
added in error.
Other Identifier Identifier
Click in the free text field and enter the

additional identification number of this trial.
James Lenoel:
To be added to the
B.Sponsors feld before
'Add Sponsor' is clicked.
Is this a resubmission?
d:
in database
Indicate the
resubmission letter or
else select 'First
submission'
Select 'Yes' for any resubmission after the initial

application has been withdrawn by the
applicant or refused by the competent authority
and 'No' for initial application. If this is simply an
update of the CTA form prior to the final
decision on the clinical trial by the competent
authority or Ethics Committee the submission
number should not be modified. If the
application received a negative opinion from
the Ethics Committee (or was withdrawn by the
applicant from the Ethics Committee) and this
is a resubmission to the Ethics Committee then
select Yes when completing this form for the
Ethics Committee.
James Lenol:
I would suggest NOT
adding 'Alternatively' as
the feld can be used for
both and should
certainly include
Surname. PLEASE
CONFIRM. I have made
the change as specifed,
nonetheless.
Click the drop-down list to select relevant

option. For a first submission select 'First
submission'. If the application is a
resubmission, select 'A' for the first
resubmission, 'B' for the second resubmission,
etc.
Is the trial part of a

Select 'Yes' for a trial part of a paediatric
Paediatric Investigation investigation plan (PIP) or otherwise, should
Plan?
mark 'No'. A paediatric investigation plan is a
development plan aimed at ensuring that the
necessary data are obtained through studies in
children, when it is safe to do so, to support the
authorisation of the medicine for children. For
more information, refer to European Medicines
Agency Paediatrics guidance pages
(http://www.ema.europa.eu/htms/human/paedia
trics/pips.htm).
EMEA Decision number Enter the European Medicines Agency's

of Paediatric
decision number for the Paediatric Investigation
Investigation Plan
Plan (PIP) where available. The value entered
should have the format: P/xxx/yyyy where 'xxx'
is 1,2 or 3 digits and 'yyyy' represents years.
The system currently allows entry of only one
decision number per clinical trial. If this trial is
included in more than one agreed PIPs please
provide one PIP decision number in field A.8
"EMA Decision number of Paediatric
Investigation Plan" and enter all other PIP
decision numbers in field A.3 "Full title of the
trial" behind the trial title.
Note: The EMA PIP decision number appears
on the title page of the Agency's decision on a
PIP in the format P/xxx/yyyy underneath the
title "European Medicines Agency decision" (In
decisions issued in the old Agency style and
format it is printed in the top right corner of the
title page.). The EMA PIP decision number is
not the same as the EMA PIP procedure
number which is formatted EMEA-xxxxxxPIPxx-yy and which appears on summary
reports, opinions, etc.
James Lenol:
Due to the possible
implementation of the id
position in the
applicaton code, within
the expanded accordian
menu, I have amended
the text in red, as it was
irrelevant in this context
and perhaps confusing.
Now reflects
functionality. PLEASE
CONFIRM OKAY BEFORE
I IMPLEMENT. As it
stands, the original
comment, which is
incorrect, is removed
'Click the blue bar to
open the section'.
Click 'Add sponsor' to add a Sponsor. Once you

have entered the Sponsor details (including
Legal Representative'), click the 'Done' button
at the bottom of the page. Later, you may edit
or delete them. Note: You can also add details
of the 'Legal Representative' (as required by
Article 19 of Directive 2001/ 20/ EC). Deleting a
Sponsor also deletes any associated Legal
Representative.
These are the details for section B.1 and B.3
Sponsor Identification Details. Enter details,
and click on other blue heading to open other
uncompleted sections. Click 'Done' when the
section is completed and you return to the
section overview level, where additional
sponsors may be added, or existing sponsor
details edited or deleted.
managing this trial. EV
Simple DB mahname
has 100 use the same
as EV. See row 10dd
Click in the free text field and enter the name of

the sponsor of the trial (see article 2 (e) of
Directive 2001/20/EC) [Insert hyperlink to
EudraLex]
James Lenol:
The sponsor contact should be a person who

works within the company/organisation
mentioned in section B.1.1. (it should not be a
person working in an applicant company
appointed by the sponsor (or by its legal
representative) to submit the application to the
National Competent Authority applicant
information is in section C).
Field lengths are as per Also known as first name or forename.
ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier
Field lengths are as per
ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier
The middle name is not mandatory. Middle

name refers to the second given name and
does not refer to any part of the family name.
For example, enter Elizabeth for Ana
Elizabeth
Field lengths are as per Also known as Surname. Alternatively use this
ICH A.3.1.3c, A.3.1.3d field to record a functional role (e.g. Head of
and A.3.1.3e Sender
regulatory affairs etc.).
Identifier
ICH A.3.1.4a (Sender
Address)
Please provide the full postal address to be

used in case NCA/EC needs to contact sponsor
by post.
Due to the possible

implementation of the id
position in the
Now reflects
CONFIRM OKAY BEFORE
I IMPLEMENT. As it
comment,
which is
James
Lenol:
incorrect,
is removed
Suggest original
text should stand as
'Click
thetoblue
to drop-down:
it refers
the bar
country
open thetext:
section'.
Original
Click the
drop-down list to select relevant
option. Note: If an
option is too long for the drop-down
box, move your mouse over it and
the entire option appears in a tooltip.
Town/city only in
database. As EV city
field in DD_MAH.

by post.
ICH A.3.1.4d (Sender

Address)

by pos
EUTCT ID of the
country
May be from any
country in the world.
ICH ICSR DTD Version
2.1 separates Tel No.
(10AN), extension
(5AN) Telephone
country code (3AN)(ICH
A.3.1.4f,g,h
respectively)
The contact details (phone number, fax, e-mail)

are those of the sponsor contact mentioned in
section B.1.2. Please include the international
or applicable area codes.

2.1 separates Fax No.
(10AN), extension
(5AN) and Fax country
code (3AN).(ICH
A.3.1.4i,j,k respectively).

ICH A.3.1.4l

or applicable area codes. Functional emails are
preferred to personal ones(e.g. like
regulatory@corporate.com or renalcancer.ctunit@hospital.org).
Reference table.
Commercial or
Non-commercial

option. A commercial sponsor is a person or
organisation that takes responsibility for a trial
which is part of the development programme
for a marketing authorisation of a medicinal
product at the time of the application
Click another blue bar to contract the section.

According to Article 19 of Directive 2001/20/EC,
"the sponsor or a legal representative of the
sponsor must be established in the
Community". If the sponsor is not established in
the EEA, they should appoint a legal
representative established in the EEA. Like the
sponsor, the legal representative can be an
individual, company, institution or organisation.
Enter details in this section if required to
comply with Article 19 of Directive 2001/20/EC
and complete any other fields. Click 'Done'
when the section is completed and you return
to the section overview level. Please note that
only one legal representative in the EEA can
act on behalf of one sponsor for the purpose of
a given clinical trial.
There can be one and

only one legal
representative for a
sponsor.
The legal representative may be a person or an

organisation.

ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.
ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.

Elizabeth
Field lengths are as per Also known as Surname.

ICH A.3.1.3c, A.3.1.3d Use this field to record a functional role (e.g.
and A.3.1.3e Sender
Head of regulatory affairs etc.).
Identifier.
Address)

used in case NCA/EC needs to contact the
legal representative by post.
Town/city only. No
detailed address held in used in case NCA/EC needs to contact the
the database. As EV
legal representative by post.
city field in DD_MAH.
James Lenol:

Address)
EUTCT ID of the
country.
Must be from the EEA
list only
Due to the possible
Please provide the full postal

address to beof the id
implementation
used in case NCA/EC needsposition
to contact
in thethe
legal representative by post.applicaton code, within
Now reflects
CONFIRM OKAY BEFORE
I IMPLEMENT. As it
comment, which is
open the section'.

(10AN), extension
(5AN) Telephone
A.3.1.4f,g,h
respectively)
position in the
Now reflects
functionality.
The contact details (phone number,
fax, PLEASE
e-mail)
CONFIRM OKAY BEFORE
are those of the legal representative
mentioned
I IMPLEMENT. As it
in section B.2.2. Please include
thethe original
stands,
international or applicable area
codes.which is
comment,
open the section'.

(10AN), extension
code (3AN).(ICH

are those of the legal representative mentioned
in section B.2.2. Please include the
international or applicable area codes.
ICH A.3.1.4l

are those of the legal representative mentioned
in section B.2.2. Please include the
b_4=Click <img title="Add New"

alt="Add New" src="/eudractweb/img/add.png"> to add other organisations.
Click 'Done' when the section is
completed and you return to the section
overview level, where additional sponsors may
Repeating with B.4.2
Include
theorname
of the
Organisation
(or
be added,
existing
sponsor
details edited
or
individual)
is providing the
finance
deleted.<brwho
/>Note:
This
sectionorshould
resources
the clinical
trial. providing
identify thefor
major
organisations
monetary
materialname
support
for Organisation
the conduct of
EUTCT ID of the
Include
theorcountry
of the
the individual)
trial. In many
this willthe
be finance
the same
country.
(or
whocases
is providing
or as
the sponsor.
theretrial.
are other
May be from any
resources
forWhere
the clinical
organisations providing significant funding or
material support these should be identified (e.g.
Click another blue bar to contract the section.
where a funding organisation or pharmaceutical
Click 'Done' when the section is completed and
company provide support for a non-commercial
you return to the section overview level.
trial ( including (but not limited to) funding,
design, implementation, data analysis and
reporting)).
The
contact point will be made publicly
Click another
to contract
section.of
available
and blue
is thebar
place
to whichthe
members
the public should address requests for
additional information about the trial. The
contact point may be at the sponsor, a trial site
or another organisation, and there may be one
per concerned Member State or one in the
Field lengths are as per The
contact
point will be made
publically
<acronym
title="European
Economic
ICH A.3.1.3c, A.3.1.3d available
and
is
the
place
to
which
members of
Area">EEA</acronym>.
and A.3.1.3e Sender
the public should address requests for
Identifier.
additional information about the trial.
Please provide a functional contact point rather
than the name of a person (e.g. Clinical Trials
Information).
Address)
Please provide a full postal address.
Town/city only. No
detailed address held in
the database. As EV
city field in DD_MAH.
The contact point will be made

publicly available and is the
place to which members of the
public should address requests
for additional information about
the trial. The contact point
may be at the sponsor, a trial
site or another organisation,
and there may be one per
concerned country or one in the
<acronym title="European
Economic
Area">EEA</acronym>.

Address)
EUTCT ID of the
country.
list only

(10AN), extension
(5AN) Telephone
ICH
ICSR DTD Version
A.3.1.4f,g,h
2.1
separates Fax No.
respectively)
(10AN), extension
code (3AN).(ICH
A.3.1.4i,j,k
ICH A.3.1.4lrespectively).

are those of the further information contact in
section B.5. Please include the international or
applicable area codes.
Kandhari:
emoved EudraCT
Complete the details of the Applicants to both

the National Competent Authority (C.1) and the
Ethics Committee (C.2). Click each of the
options to open the sections, then click 'Done'
button when the sub-section is complete.
etent Authority
Identification of the CA
applicant for this CT in
this MS. Selection by
drop down list :
Sponsor or
Legal representative of
the Sponsor or
Person or organisation
authorised by the
Sponsor
Enter details for section C.1 Applicant

Identification - Request for the National
Competent Authority then click 'Done' button
when the sub-section is complete.
option, dependent upon whether the applicant
is the sponsor, the legal representative of the
sponsor or the individual or organisation
appointed by the sponsor to submit the
application.
James Lenol:
No id available for this
section, since it's not
been implemented in
the application. I have
included this text in the
properties fle so it will
only be displayed if an
id is added which is
equal to 'd_2_1_1'.
Please confrm if the
inclusion is IMPERATIVE
via JIRA to the team in
Greece.
This is the Applicant to the National Competent

Authority (NCA) and is the party with whom the
NCA will routinely correspond. Enter the details
of the legal applicant (who will sign the form).
The legal applicant may be the sponsor, the
legal representative if the sponsor is
established outside the EEA, or an individual or
company appointed by the sponsor (or by its
The
Applicant Contact
(or the
contact
person)
legalNCA
representative)
to submit
application
should
be
a
practical
contact
and
might
notinbe
to the NCA. The applicant must be based
the
the
signatory
of
the
application,
but
may
be the
European Union. The NCA Applicant Contact
same
person
as the
one mentioned
in section
may be
a different
individual
at the same
B.1.2
if
the
sponsor
is
the
applicant
(or
in
Location/Organisation, if necessary.
section B.2.2 if the legal representative is the
The
full, official
name of
the Applicant
applicant).
The family
name,
at least, should be
Organisation.
provided in C.1.4.2, or be completed with a
function (e.g. Head of regulatory affairs). All
the fields should be completed even when this
repeats the sponsor or legal representative
information from B.1 and B.2.
Also known as first name or forename.
Kuljit Kandhari:
To be implemented in
The middle name
EudraCT V9
is not mandatory. Middle

Also
known as Surname.
Elizabeth
Use this field to record a functional role (e.g.
Head of regulatory affairs etc.).

Address)
The building name and/or number and street

name.
Town/city only. No
detailed address. As
EV city field in
DD_MAH.
Address)
The address' post code (where applicable).
EUTCT ID of the
country.
Full worldwide list from
Version 4.0.0

option.

(10AN), extension
(5AN) Telephone
A.3.1.4f,g,h
respectively)

are those of the National Competent Authority
in section C.1.4.2. Please include the

(10AN), extension
code (3AN).(ICH

James Lenol:
No id available for this
section, since it's not
been implemented in
the application. I have
included this text in the
properties fle so it will
only be displayed if an
id is added which is
equal to 'd_2_1_1'.
Please confrm if the
inclusion is IMPERATIVE
via JIRA to the team in
Greece.
James Lenol:
Added URL hyperlink, to
EVMPD front page:
http://eudravigilance.em
ea.europa.eu/human/ev
Mpd01.asp
ICH A.3.1.4l
Feedback xml file

request

C.1.5.1 is a MANDATORY FIELD and if the

answer is 'Yes' then C.1.5.1.1 should contain at
least one email address.
Up to 5 email addresses If you answered 'Yes' to C.1.5.1 then you may

for xml file feedback
provide up to 5 email addresses below to which
copies of the CT Application XML file will be
sent via EudraLink. These email addresses
must have Eudralink accounts for secure
password protected delivery unless you answer
'No' to C.1.5.1.2 for delivery without password
protection.
Recipient must have a

EudraLink account
James Lenoel:
For search: Use the drop-down
flter to search for exact matches
(equals) or partial Ids (starts with).
Select 'Yes' if you require secure email delivery

of the XML.
For validation guidance, please note that
C.1.5.1.2 is a MANDATORY FIELD: If C.1.5.1 is
answered 'No' C.1.5.1.2 answer should also be
'No'. If C.1.5.1 is 'Yes', C.1.5.1.2 may be either
'Yes' or 'No'.C1.5.1.2. by default should be
blank.
This section is not mandatory. It should be

completed for applications to ethics committees
in those Member States where the Ethics
Committee requests this form as part of the
Identification of the IEC Click the drop-down list to select relevant
application to them. Once complete, click
applicant for this CT in option.
'Done' button when the sub-section is
this MS. Selection by
complete.
radio button or dropdown list.
If you answered 'Yes' to C.1.5.1

then you may provide up to 5
email addresses below to which
copies of the CT Information
XML will be sent via EudraLink.
These email addresses must
have Eudralink accounts for
secure password protected
delivery unless you answer 'No'
to C.1.5.1.2 for delivery without
password protection. Note: Ensure that this field
does not contain any spaces
within or outside the body of the
email address, or rubbish data
(e.g. XXXX). Failure to do so,
may cause issues with the
validity of the XML.
This is the Applicant to the Ethics Committee.

Enter the details of the legal Applicant (who will
sign the form). The Contact Name may be a
different individual at the same Location/
Organisation. The Phone, Fax and E-mail
should be those of the Contact person.
Also known as first name or forename.

Elizabeth
James Lenoel:
For search: Use the drop-down flter
to search for exact matches (equals)
or partial Ids (starts with).
Also known as Surname.

Use this field to record a functional role.

Address) only. No
Town/city
EV city field in
DD_MAH.

name.

Address)
EUTCT ID of the
country.
list only

option.

(10AN), extension
(5AN) Telephone
A.3.1.4f,g,h
respectively)

are those of the IEC in section C.2.5.2. Please
include the international or applicable area
codes.

(10AN), extension
code (3AN).(ICH

codes.
James Lenol:
Will display only if the id
for this feld is equal to
'q_27'.
James Lenol:
Will display only if the id
for this feld is equal to
'q_21'.
ICH A.3.1.4l

codes.
To Add an IMP:
Click 'add IMP' to start the first IMP or create
another one. Once an IMP is added, it appears
d:
in the IMP details table. Options for 'edit IMP',
ng ATC as a basis, but build the list and
'delete IMP', 'copy IMP', 'search active
CT
edicinal Product Repeating group substances' and 'add active substance' are
then displayed for that IMP.
erology - Hepatology
Once
is complete
clickIMP:
the
To Addthe
ansub-section
Active Substance(s)
to this
'Next'
button
at
the
bottom
of
the
page
to
As a first preference use 'search active move
to
theIMP
nexthas
sub-section..
gy - Hemostaseology
If
the
Marketing
in the
substances'
to afind
and addAuthorisation
an active
Use
'Next'
at
the
footlist
ofof
each
screen
to ensure
Member
State
concerned
by this
application
but
substance
from
the
available
active
y - Rheumatology
Unique
- Transplantation
sequence
Unique
sequence
number
for
the
repeating
completion
of
all
questions
in
Section
D.
the
trade
name
and
marketing
authorisation
substances
in the Medical
Product Dictionary
y
number for the
products.
Format:
NOTE:
If there
is noPRnn.
'Test IMP'go
or to
holder
are
not fixed
inclear
the protocol,
ogy
(MPD).
repeating products.
'Comparator'
in
your
study
design,
indicate
all
section
D.2.2.
ular Diseases
If your active substance is not available from
IMPs
as
'Test
IMP'.
Each
strength
and
y - Allergology Format: PRnn
third_d_2=If
IMP
has substance'
a Marketingand
the MPD usethe
'add
active
Diseases - Parasitology
pharmaceutical
should
be recorded
a
Authorisation
in form
the
country
concerned
byas
this
Field
to
describe
the
Choose
the
IMP
Category
from
the drop-down
complete
the
fields
provided.
aryngology
separate
Investigational
Medicinal
Product
(use
application
but
the
trade
name
and
marketing
role of the product in the list.
Complete all questions in Section D for each
logy
'copy
IMP'
andholder
edit
the
strength
ofineach
active
are
not fixed
thesame
trial.- Fertility - Metabolism authorisation
gy - Gynaecology
IMP, but
if most
of the
answers
are
the
substance
and/or
pharmaceutical
form
of
protocol,
go
to
section
D.2.2.If
the
IMP
has
a
y - Paediatric Intensive Care
for any additional IMP(s) (e.g. 3 tablets of the
IMP).
Marketing
Authorisation
in
the
Member
State
different strength), then enter one IMP, use the
ology
concerned
by this application
but the
trade
'copy IMP' function
on this screen,
then
edit the
name
and
marketing
authorisation
holder
relevant
fields
in the copy
and update
the are
not
fixed in the
go to section D.2.2.
information
(e.g.protocol,
Strength).
H section 3 or ICD10
e multi-select
If 'No' then go to D.3.

If 'Yes'
complete section D.2.1.1.1 to
in V7 was only used to search for an AS, but
not tothen
be entered
D.2.1.1.4
UNLESS
the IMP has a Marketing
omatically by the system and it should be part
of testing
to make
Authorisation in the Member State concerned
by this application but the trade name and
marketing authorisation holder are not fixed in
If
the
IMP hasInasuch
Marketing
Authorisation
in the
the
protocol.
a case,
complete D.2.1.2
country
is sourced
for use
in this
with the from
namewhich
of theit Member
State
to which
Clinical
Trial, please
complete
this section
the application
is submitted,
answer
'Yes' towith
the
information
relevant
to thethe
country
from
D.2.1.2.1,
and then
complete
section
D.2.2.
If the IMP
has a Marketing
in the
which
the product
has beenAuthorisation
sourced.
country from which it is sourced for use in this
clinical trial, specify the Product Name as
Product Tradename
registered by the Marketing Authorisation
Holder (MAH). It is available from the Summary
of Product Characteristics (SmPC), or product
labelling.
EV additional field for
future use
Specify the EudraVigilance Product Code here
when available (obtained from Eudravigilance
Medicinal Product Dictionary EVMPD).
MA holder
Available from the Summary of Product

Characteristics (SmPC), or Product Labelling.
For more information, see details in
Neil Cordwell:
3rd EudraPharm
Country only [insert a link].
If the IMP has a Marketing

Authorisation in the country
concerned by this application
but the trade name and
marketing authorisation holder
are not fixed in the protocol, go
to section D.2.2.
If 'No' then go to D.3. If
'Yes' then complete section
D.2.1.1.1 to D.2.1.1.4. UNLESS the IMP has a
Marketing Authorisation in the
country concerned by this
application, but the trade name
and marketing authorisation
holder are not fixed in the
protocol. In such a case,
complete D.2.1.2 with the name
of the country to which the
application is submitted, answer
'Yes' to D.2.1.2.1, and then go
to section D.2.2.
Neil Cordwell:
3rd Country only
MA number
Available from the Summary of Product

Characteristics (SmPC) or Product Labelling.
Answer 'Yes' if there are any trial-specific

operations that could affect the product quality,
such as modification of the pharmaceutical
form (e.g. over-encapsulation, colour, dilution,
re-tabletting for blinding etc.) or removal from
the primary packaging and repacking (e.g.
removal from a blister and putting in a bottle). If
the blinding consists in over encapsulating
tablets, trial specific coating (modified colour, or
debossing), this information should be reported
here. Answer 'No' If the product has only
been relabelled or repackaged.
If Y to D.2.1.1.4 this is
the text describing the
modification
If question D.2.1.1.4 is answered 'Yes' then

question D.2.1.1.4.1 should be answered,
providing details of the modification.
EUTCT ID of the
country that granted the
MA.
May be from any
Specify the name of the country where the

holder was granted the Marketing Authorisation
of the actual IMP to be used in the clinical trial
in the Member State concerned by the
application.
If the IMP has a MA in several countries, enter
the name of the country (or of one of the
countries, if one of them is a Member State,
choose this one) that granted the MA for the
actual IMP to be used in the trial in accordance
with section D.2.1.1.2.
Where the product is a Centrally Authorised
Product, give the Member State in which the
product was intended to be marketed (i.e. the
one for which it is labelled) or, if bulk product is
used, choose one of the Member States.
Specify the name of the country

where the holder was granted
the Marketing Authorisation of
the actual IMP to be used in the
clinical trial in the country
concerned by the
application. If the IMP has
a Marketing Authorisation in
several countries, enter the
name Neil
of theCordwell:
country (or of one
of the Implement
countries, link
if one of them
is a Member State, choose this
one) that granted the MA for the
actual IMP to be used in the trial
in accordance with section
D.2.1.1.2. Where the
product is a Centrally
Authorised Product, give the
Member State in which the
product was intended to be
marketed (i.e. the one for which
it is labelled) or, if bulk product
is used, choose one of the
Member States.
The country at D.2.1.2

Answer 'Yes' if the Marketing Authorisation of
is this Member
State
the IMP to be used in the clinical trial in the
Kuljit
Kandhari:
was:If 'not accepted',
Member State concerned by the application
give the eventual
was granted by the same Member State.
anticipated date of
Answer 'No' if the Marketing Authorisation was
resubmission
granted by another country.
Answer 'Yes' if the Marketing

Authorisation of the IMP to be
used in the clinical trial in the
country concerned by the
application was granted by the
same country. Answer 'No'
if the Marketing Authorisation
was granted by another country.
The country at D.2.1.2

is another Member
State
Complete this section when the IMP has a
Marketing Authorisation in the Member State
concerned by this application, but the trade
name and marketing authorisation holder are
not fixed in the protocol. You should also have
answered 'Yes' to D.2.1 and have completed
D.2.1.2 with the name of the Member State to
which the application is submitted, and 'Yes' to
D.2.1.2.1.
Complete this section when the

IMP has a Marketing
Authorisation in the country
concerned by this application,
but the trade name and
marketing authorisation holder
are not fixed in the protocol. You
shouldJames
also have
answered
Lenol:
'Yes' toATIMP
D.2.1replaced
and have
with
completed
D.2.1.2
with the
Advanced
Therapy
IMP,
to country
statement
name due
of the
tofrom
which
Fergus at is
oursubmitted,
review
the application
about shying away from
and 'Yes'
to D.2.1.2.1.
acronyms
that might be
unfamiliar. PLEASE
CONFIRM OKAY.
If yes then the Active

This should be answered 'Yes' when the
substance section must protocol only identifies the INN and the
be completed.
investigator can use whichever brand is locally
available. The protocol of the clinical trial
may specify only the INN of the product used in
the trial (for example paracetamol) when, for
the same active substance there are several
different trade names available in the Member
state concerned and no one of them is
specified by the protocol.
If yes then ensure that

the Active substance
section must be
completed.
If D.2.2.1 (above) is answered 'Yes' then

D.2.2.2 may be 'Yes' or 'No'. The
applicant should tick the 'Yes' box if, in the
protocol, treatment regimens for the
Investigational Medicinal Product allow different
combinations of marketed products (only
defined by their INN) used according to local
practice at some or all investigator site in the
concerned Member State (this case is
frequently observed in oncology or HIV clinical
trials). In this case each site might have a
different combination compared to other sites.
If yes then ensure that

the ATC field of the
form is completed.

D.2.2.3 must be 'No'. However, if the answer to
this field is 'Yes' then D.2.2.1, D.2.2.2 and
D.2.2.4 should be 'No'.
This should only be answered when the parent
question (D.2.2.3) is answered 'Yes'.
Radio buttons

D.2.2.4 must be 'No'.
To be completed only if
the question above
(D.2.2.4) is set to Y

specification of the IMP identification (up to 500
characters). This should only be answered
when the parent question (D.2.2.4) is answered
'Yes'.
If 'Yes' please provide justification for using

simplified dossier in the covering letter. Refer to
the detail guideline CT1 Section 2.7.3 and
Table 1
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?
uri=OJ:C:2010:082:0001:0019:EN:PDF
When the IMP has a marketing authorisation in
the EEA or in an ICH country and it is used
within the conditions of the SmPC, the
applicant may submit the current version of the
SmPC (or, as regards ICH countries, the
documentation equivalent to the SmPC) as the
IMPD.
James Lenol:
Unlikely to display. An id
with 'l_2_3' will allow it
to display within the
application, if
applicable.
James Lenol:
This text will not appear
in the application as
there is no id for this
element, since the
implementation doesn't
automatically include
feld ids for headings,
sub-headings etc. As a
result, I have added the
text to the following two
sections as a
workaround. PLEASE
CONFIRM
Has this product been

authorised for use by
this sponsor in a CT in
the Community before?
No further details of
such previous use are
captured
In this section, the term "authorised" should be

understood in the context of Directive
2001/20/EC (that is to say an authorisation,
according to Directive 2001/20/EC, has been
given for a trial using this IMP).
To select one country, click the country and

then click 'Copy'.
To select more than one country, hold CTRL
then click the countries and then click 'Copy'.
To select all countries, click Copy All button.
Has this IMP been

designated in this
indication as an orphan
product in the
Community ?
According to the Community register on orphan

medicinal products (Regulation (EC) n
141/2000):
http://pharmacos.eudra.org/F2/register/orphreg.
htm
If row 48 = Y then this is The orphan drug designation number is available on the following web site: http://pharmacos.eud
the orphan product
designation number for
this product and
indication. Community
register on orphan
medicinal products
format EU/n/nn/nnn.
Has this IMP been the
subject of scientific
advice ?
D.2.6 should be answered 'Yes' if scientific

advice in relation to the clinical trial concerned
by this application has been given by a
European regulator. This scientific advice may
be given by a National Competent Authority or
by the CHMP (European Medicines Agency) or
both.
Was Scientific Advice (SA) from Committee for

Medicinal Products for Human Use (CHMP)
received?
Was Scientific Advice (SA) from a National
Competent Authority received?
James Lenol:
element, since the
In the absence of a
To be provided only when there is no
Tradename this is the
tradename. This is the name routinely used by
name routinely used by a sponsor to identify the IMP in the CT
the sponsor in the
documentation (protocol, IB...) Note: It is
clinical trial
Mandatory to complete D.3.1.and/or D.3.2 if
documentation e.g.
question D.2.1 was answered 'No' if question
patient information
D.2.1 was answered 'No'.
leaflet, protocol, IB.
If the sponsor does not
Kuljit
have a specific product
Kuljit Kandhari:
Kandhari:
is G.1.5.6
onAnnex
the
Is G.1.5.5
on the
name, and only the This
Annex
CTA Form
CTA
Form
active substance name
or code is available the
product name is a
concatenation of
Substance code or
name/concentration
Code defined by the
sponsor, potentially
used in case of
combination of drugs
and devices but not
routinely anticipated.
This field is not required
if the Tradename of an
authorised product (in
the EEA) has been
provided. This field may
be blank if no product
code has been
assigned by the
sponsor.
To be provided only when there is no

tradename. This is a code designated by the
sponsor which represents the name routinely
used by the sponsor to identify the product in
the CT documentation. For example, a code
may be used for combinations of drugs or
drugs and devices. Note: It is Mandatory to
complete D.3.1.and/or D.3.2 if question D.2.1
was answered 'No' if question D.2.1 was
answered 'No'.
7-character
alphanumeric at level 4.
this should only be
entered when the
product is used in the
clinical trial within the
terms of the marketing
authorisation.
If the product has a Marketing Authorisation in

the concerned Member State, the applicant
should include the Anatomical, Therapeutic,
Chemical (ATC) code for this product. This is
available from the Summary of Product
Characteristics (SmPC). Click 'Add ATC code'
button if you wish to include an additional ATC
code.
Note: It is mandatory to include at least one
ATC code
this field if question
is
Select
the in
pharmaceutical
form ofD.2.2.3
the actual
answered
'Yes'. in the clinical trial from the
IMP
to be used
drop-down menu. Note: Mandatory field unless
D.2.2 is 'Yes'.
Originally for the

Sponsor-generated
ATC code for this
product. No longer on
screen from 3.0.1
Answer 'Yes' if the formulation is specifically for
paediatric usage.
James Lenol:
element, since the
sub-headings etc.
Suggest it is flagged as
an enhancement for the
next release. The id in
the properties fle
should equal 'd_5_4' so
that the text specifed is
correctly displayed.
Neil Cordwell:
James
Lenol:
Automatic
feld. If you
Business
enter a placebo the
logic/functionality
system ticks the radio
question:
button.
James Lenol:
in the application v8.0
as there is no id for this
element, since the
sub-headings etc.
Suggest it is flagged as
an enhancement for the
next release. The id in
the properties fle
should equal 'd_6_1' so
If the product
Marketing
that the has
text a
specifed
is
Authorisation
the concerned
correctlyindisplayed.
country, the applicant should

include the Anatomical,
Therapeutic, Chemical (ATC)
code. This is available from the
Summary of Product
Characteristics (SmPC).
Click 'Add ATC code'
button if you wish to include an
additional ATC code. Note: It is mandatory
to include at least one ATC
code in this field if question
D.2.2.3 is answered 'Yes'.
Pre-3.0.1 max duration

and dose was in
Section G and general
to the whole trial. From
3.0.1 these fields are for
each specific IMP
Kandhari:
us feld was
ID which is not
ed.
This field should NOT be completed by simply

indicating 'See protocol'. Include the duration of
administration of the IMP to a subject. (e.g. If it
is intended, in accordance with the protocol, to
treat a subject during 3 weeks, specify 'three
weeks'.
If the IMP is not administered on a continued
basis, specify the rhythm of the product
administration. For example, regarding a
clinical trial in oncology, if the treatment is
administered at day 1 and day 2 every four
weeks, specify 'D1 and D2 every four weeks',
mentioning the maximum number of cycles
foreseen. Warning: The treatment duration
(period of time during which the patient is
administered with the IMP) is not the same as
the period of participation of a patient (period of
time during which the subject is followed up
within the context of the clinical trial). Note:
Mandatory field unless D.2.2 is 'Yes'.
James Lenol:
Changed as per JL
correction.
James Lenoel:
Proposed text waiting
for confrmation from
Stephen Fletcher.
D.3.6 are MANDATORY FIELDS. Choose the

most appropriate answers in each sub-section
by checking the appropriate box (dose per day
or total dose), and by specifying the maximum
dose administered (concentration and
concentration unit, and the route of
administration related to the maximum dose). It
is evident that the maximum dose may relate to
one of the other strengths or routes of
administration for this IMP so the same answer
may apply to several of the related copies of
this IMP data in this CTA.. The route of
administration should be one of those checked
at D.3.7.
If the IMP is administered in this trial for the first
time in humans (FIH), click in the free text field
and enter the details of the first dose (up to 250
characters). This is a read only field and
displays data entered prior to the EudraCT v8.1
release. For any updates or new entries, please
use subsequent D.3.6.1 radio buttons.
Choose the most appropriate answer from
'Dose per day' or 'Total dose'.
Note: 'Dose per day' is the max. dose per day
and 'Total dose' refers to the total dose in the
trial.
Click in the free text field and specify the
amount of IMP (numeric quantity) administered
per dose. Use drop-down list at the next field to
specify units.
James Lenoel:
Proposed text in green
awaiting System Analyst
approval.
James Lenoel:
Insertion of hyperlink to MeSH:
http://www.nlm.nih.gov/mesh/
Specify the units of the dose being described.

Click the drop-down list to select relevant option
- specify the route of administration related to
the first dose.
maximum single dose allowed in numbers and
units. This is a read only field and displays data
entered prior to the EudraCT v8.1 release. For
any updates or new entries, please use
subsequent D.3.6.1 radio buttons.
Choose the most appropriate answer from
'Dose per day' or 'Total dose'.
Note: 'Dose per day' is the max. dose per day
and 'Total dose' refers to the total dose in the
trial.

amount of IMP (numeric quantity) administered
per dose. Use drop-down list at the next field to
specify units.
Use EV
Specify the units of the dose being described.
LK_CONCENTRATION
UNIT lookup table
drop down list (ICH
measureunit +
additional values).
Longest unit name is 38
chrs: IU/mg
international
unit(s)/milligram
Click the drop-down list to select the Route of
Administration which the maximum dose refers
to.
James Lenoel:
Include a hyperlink to MedDRA website:
For more information see:
http://www.meddramsso.com/
aemps: the defnition as published by EMA at

http://www.emea.europa.eu/htms/human/orph
s/intro.htm is 5 / 10,000 (mathematically is
same but 5 / 10,000 is the "legal" defnition)
Multi select
To select one Route of Administration, click the

appropriate option and then click 'Copy'.
To select more than one Route of
Administration hold CTRL then click the Routes
of Administration and then click 'Copy'.
To select all Routes of Administration click
Copy All button. Click the 'Continue' button at
the bottom of the page to move to the next subsection.
Note that selecting 'Continue' will take you to
section D.3.11 Type of IMP and from there, if
applicable, to sections D.4, D.5 and D.6. Only
then can sections D.3.8 to D.3.10 for active
substances be accessed by selecting 'add
active substance' for this IMP at the IMP
Identification Index screen.
You are encouraged to use terms that are not
'non-current'. Note: This is a Mandatory field if
your precise term is not available use the free
text field and include it in your cover letter.
Complete all fields that currently apply to this

Active Substance in this IMP. If you have IMPs
with different concentrations of the Active
Substance please complete a new IMP entry
for each concentration of the active substance.
To do this you can complete one full section D
IMP and Active Substance then copy the IMP
and edit the concentration in the copy(ies).
CAS=Chemical Abstract Services Number.
Other Descriptive Name may be used for
biological/ biotechnological Products that do not
have an INN or Proposed INN.
James Lenoel:
*Ref: ICH GCP defnition of Vulnerable
Subjects: http://ichgcp.net/?page_id=432
The International Nonproprietary name for

this active substance.
ICH B.4.k.2.2
activesubstancename is
100AN.
Pre 3.0.1 there were
two fields for an INN
and a Proposed INN.
These two fields were
combined into one at
3.0.1
Specify the International Nonproprietary Name

(proposed or final) (up to 150 characters).
If the product is a combination product, specify
the name of all active substances, by adding
each active substance separately to the IMP.
For marketed products, the INN is available in
the SmPC. For EU marketed products, the INN
is available in section 2 of the EU SmPC
entitled "Qualitative and quantitative
composition".
Another descriptive name may be used in
specific situations, for example for products of
biological or biotechnological origin that have
no INN or proposed INN, or where it is an
alternative name which is not registered as INN
or proposed INN. Note: It is not necessary to
answer D.3.8 if D.2.2.3, D.2.2.4 are answered
'Yes'.
If available, specify this active substance's CAS

number (a unique numeric identifier for
chemical entities). CAS' format is nnnnnn-nnn-c
where c is a check digit and leading zeros may
be suppressed (up to 12 characters). For more
information, please check http://www.cas.org
The current code in use Click in the free text field and specify the active
by the sponsor for this substance's (AS) current sponsor code (up to
active substance.
100 characters).
Any other descriptive
name for this active
substance.
Size increased to 500
chars in V8
Click in the free text field and specify another

descriptive name for biological/
biotechnological Products that do not have an
INN or Proposed INN (up to 500 characters).
EV code of substance - Click in the free text field and specify the active
field in use from 3.0.1
substance's EudraVigilance Substance Code
(up to 15 characters).
Include the full molecular formula for the active
substance.
James Lenoel:
Include hyperlink to referenced PDF in
tooltip implementation.
JL confrms that the following appears on
the cover page of the document: DATE FOR
COMING INTO OPERATION March 1998
JL confrms that the following appears on

the cover page of the document: DATE FOR
COMING INTO OPERATION March 1998
Please note that in this section the strength /

concentration should be given for each different
pharmaceutical form and/or strength of the
Investigational Medicinal Product being used in
the trial (for example amount of active
substance per tablet) and not the dose
administered to the subject. D.3.10, D.3.10.1,
D.3.10.2, D.3.10.3 are Mandatory fields except
where D.2.2 is 'Yes'.
D.3.10.3 should be a single numeric value in
the first field (can be a decimal) or in both fields
only where D.3.10.2 is set to 'Range'.
Use EV
LK_CONCENTRATION
UNIT lookup table
drop down list (ICH
measureunit +
additional values).
Longest unit name is 38
chrs: IU/mg
international
unit(s)/milligram
The unit of measurement used for the

concentration of the active substance may be
selected from the drop-down list. If a unit for
your product is not available in the list, please
provide an explanation regarding the unit value
in section D.3.9.6.
Use EV
Select the active substance's concentration
LK_CONCENTRATION type from the drop-down list.
TYPE lookup table
drop down list
See EV
Use this field only if D.3.10.2 is NOT set to
DD_DRUGSUBSTANC 'Range'.
E concentration
See EV
Use this field only if D.3.10.2 is set to 'Range'.
DD_DRUGSUBSTANC
E concentration 2
e product Repeating Group
Does the product

contain an active
substance of chemical
origin ?
Does the product

contain an active
substance of biological
or biotechnological
origin ?
D.3.11.1 and D.3.11.2 are MANDATORY fields at least one should be marked 'Yes'.
Select 'Yes' if the IMP is obtained by chemical
synthesis. Note: In some cases, where there
are two or more active substances in one IMP,
it is possible that both D.3.11.1 and D.3.11.2
would be marked 'Yes'.
Select 'Yes' for IMPs where the active
ingredient(s) are biological product(s) of human
or animal origin, or contain biological
components of human or animal origin, or the
manufacturing of which requires such
components. If the IMP is an advanced therapy
medicinal product select 'No' and instead select
'Yes' to D.3.11.3.
James Lenoel:
? Business Analyst to
confrm in DD.
aemps: reference to
marketed medicinal
product may be
misleading here and it is
irrelevant from the
methodology point of
view
James Lenoel:
Business to provide an agreed
defnition for each phase of Clinical
James Lenoel:
Trials.
Business to provide an agreed defnition for
each
phase
of Clinical Trials.
James
Lenoel:
Business to provide an
agreed defnition for
each phase of Clinical
Trials.
Select 'Yes' if the IMP is considered an

Advanced Therapy IMP.
Note: If this field is marked 'Yes', ensure that
the following subquestions below, as well as
section D.5 are completed.
Does the proposed
clinical trial entail a
somatic cell therapy
medicinal product ?
Select 'Yes' if this Advanced Therapy IMP is a

somatic cell therapy medicinal product?
Does the proposed

gene therapy medicinal product?
gene therapy medicinal
product ?
tissue engineered medicinal product?
Select 'Yes' if the Advanced Therapy IMP is a
combined product involving a medical device?
If the Committee on Advanced Therapies (CAT)
has issued a recommendation for classification
for this IMP, select 'Yes'.
For more information on the Committee on
Advanced Therapies, see CAT Overview
[http://www.ema.europa.eu/htms/general/contac
ts/CAT/CAT.html]
Click in the free text field and specify the CAT
classification and reference number. See
<insert CAT site hyperlink> for more details.
Select 'Yes' if this IMP includes a medical
device but does not involve an advance therapy
medicinal product.
Does the proposed
radiopharmaceutical
medicinal product ?
Select 'Yes' if this IMP is a radiopharmaceutical

medicinal product.
Does the proposed

clinical trial entail an
immunological
medicinal product (such
as a vaccine, allergen,
immune serum, etc) ?
Select 'Yes' if this IMP is an immunological

medicinal product (such as a vaccine, allergen,
immune serum, etc.), whether it is for
prophylactic or therapeutic use.
Plasma derived
medicinal product
Select 'Yes' if the IMP is a medicinal product

derived from human blood or plasma.
Note: if you answered yes here, D.3.11.2
should also have been answered Yes.
Other extractive
medicinal product
Select 'Yes' if the IMP is of biological or

biotechnological origin but does not fit any of
the categories listed above and is obtained by
extraction from biological material.
Note: If this question is answered 'Yes',
D.3.11.2 should also have been answered 'Yes'.
http://www.e
general/con
Select 'Yes' if the IMP was produced using

recombinant technology.
Note: If this question is answered 'Yes',
D.3.11.2, should also have been answered
'Yes'.
Does the proposed
medicinal product
containing GMOs?
Select 'Yes' if this IMP contains Genetically

Modified Organisms.
Note: If 'this question is answered 'Yes',
D.3.11.2, should also have been answered
'Yes'.
This section should be completed only if the
IMP is a medicinal product containing
genetically modified organisms.
Is this authorised for

contained use ?
This question should be answered only if the

Is authorisation pending This question should be answered only if the

?
Does the proposed
herbal medicinal
product?
Select 'Yes' if this IMP contains an active

substance of herbal origin.
Does the proposed

Select 'Yes' if this IMP is a homeopathic
medicinal product.
homeopathic medicinal
product?
Select 'Yes' if the IMP is a medicinal product of
a type not detailed above. E.g medicinal gas.
If this is 'Other' type of IMP, specify the type of
IMP (up to 200 characters).
How the active

substance works
Free text
(To respond to HMA's
requests)
Enter the mode of action of the active

substance of this medicinal product (up to 500
characters). Abbreviation should be avoided if
possible.

requests)
Select 'Yes' if the active substance contained in

this IMP is to be administered for the first time
in a clinical trial (first-in-human (FIH) clinical
trial).
Note: If you answer 'Yes' here, you should also
answer 'Yes' in E.7.1.1. and also complete
question D.3.6.1.

requests)
Click in the free text field and enter any risk

factors identified in accordance with first-inhuman guidance (up to 500 characters).
This section is not applicable therefore
removed text.
http://www.e
N/A
N/A
N/A
If D.3.11.2 = Y then is
N/A
the
biological/biotechnologi
cal active substance
GMO (genetically
modified origin) ? Note
that the guidance for the
form has further fields
regarding the
authorisation for
contained use but the
guidance for the
database does not.
N/A
N/A
N/A
The questions on this part of the form relate to

IMPs containing cell therapy medicinal
products. These questions are MANDATORY if
you have answered 'Yes' at D.3.11.3.1 and
should be completed only if the IMP is a cell
therapy medicinal product. All of D.4.1 and
D.4.2 should be answered. Click the 'Continue'
button at the bottom of the page to move to the
next sub-section.
If D.3.11.3 = Y is the
origin of the cells
autologous ?
Select 'Yes' if cells to be used in the therapy

derive from the trial subject himself.
origin of the cells
allogeneic ?

derive from a human donor other than the trial
subject.
origin of the cells
xenogeneic ?

derive from a species other than human.
If D.5.1.3 = Y then enter Click in the free text field and enter the species
here the species of
origin (up to 200 characters).
origin of xenogeneic
cells
the type of cells stem ?
Select 'Yes' if the cells come from an

undifferentiated (stem) line.
the type of cells
differentiated ?
Select 'Yes' if the cells come from an

differentiated cell line (non-stem). Also you
should specify the type of cells in D.4.2.2.1.
If D.5.2.2 = Y then this Click in the free text field and enter the
holds the description of differentiated type of cells (up to 200
the differentiated cell
characters).
type (eg keratinocytes,
fibroblasts,
chondrocytes, etc).
A cell therapy type not
identified in D.5.1.1 to
D.5.2.2.1

derive from a type other than the options
available above.
If D.5.2.3 = Y then this Click in the free text field and enter the type of
holds a description for cells, if not available in the above options (up to
cell types other than
200 characters).
stem and differentiated..
IMPs containing gene therapy medicinal
products. These questions are asked if you
have answered 'Yes' at D.3.11.3.2.Note: If
D.3.11.4 is 'Yes' then section D.5 is
MANDATORY. All questions D.5.1 to D.5.5
should be answered. The free text boxes
should only be completed when the related
parent question is ticked 'Yes'. Click the
'Continue' button at the bottom of the page to
move to the next sub-section.
Free text list of the
genes of interest
Click in the free text field and enter the genes

of interest (up to 500 characters).
Select 'Yes' if the gene therapy medicinal
product is administered to the trial subject.
Select 'Yes' if the gene therapy medicinal
product is used in order to modify cells outside
the trial subjects body and that these modified
cells are administered to the trial subject.
The sub-questions D.5.4.1., D.5.4.2. and
D.5.4.3 should be completed.
Select 'Yes' if the gene transfer product is a
nuclelic acid. Note: If section D.5.4.1. is
answered 'Yes', sub-sections D.5.4.1.1. and
D.5.4.1.2 should be completed.
Select 'Yes' if the gene therapy entails

operations with naked nuclelic acid.
Select 'Yes' if the gene therapy entails
operations with nuclelic acid, other than naked.
Select 'Yes' if the gene therapy entails the use
of a viral particle as a vehicle for the nuclelic
acid.
Enter the type of virus used as vector, for
instance, adenovirus, retrovirus, AAV, etc (up to
100 characters).
Gene therapy other
than Nucleic or Viral
If D.6.4.3 = Y then enter Enter the gene transfer product type (up to 100
here free text for any
characters).
other gene transfer
product.
If D.3.11.4 = Y does this Select 'Yes' if the IMP contain genetically
gene therapy involve
modified cells.
genetically modified
cells ?
If D.6.5 =Y is the origin

of the genetically
modified cells
autologous ?
Select 'Yes' if cells derive from the trial subject

himself.

of the genetically
modified cells
allogeneic ?
Select 'Yes' if cells derive from a donor other

than the trial subject.

of the genetically
modified cells
xenogeneic ?
Select 'Yes' if cells derive from a species other

than human.
If D.6.5.3 = Y then enter Click in the free text field and enter the species
here the species of
origin of xenogeneic
cells
Are the cells of a type
other than differentiated
and / or stem.
Enter here free text for
the type of genetically
modified cells (eg
haematopoietic stem
cells, etc)
Click in the free text field and specify the type

of cells involved in the IMP (up to 200
characters). If D.6.5 is 'Yes', this field must be
completed.

IMPs containing Tissue Engineered medicinal
products. Note: If you have answered 'Yes' at
D.3.11.3.3, section D.6. should be completed. If
D.3.11.3.3, is answered No, section D.6.should
be left blank.
Indicate the origin of cells in the tissue
engineered product.
Select 'Yes' if cells derive from the trial subject
himself.
Select 'Yes' if cells derive from a donor other
than the trial subject.
Select 'Yes' if cells derive from a species other
than human.
Click in the free text field and enter the species
Select 'Yes' if the tissue has been grown or is

made of non-differentiated cells.
Select 'Yes' if the tissue has been grown or is
made of differentiated cells.
Enter the differentiated type of cells (up to 200
characters).
Select 'Yes' if the tissue is of other type than

those mentioned in previous items. Please
specify the type in D.6.2.3.1.

IMPs containing devices. Note: If you have
answered 'Yes' at D.3.11.3.4 or D.3.11.4 section
D.7 should be completed.
Click in the free text field and enter a short
description of the device (up to 200 characters).
tradename of the device (up to 200 characters).
Select 'Yes' if the device is to be located within
the subject's body.
Select 'Yes' if the IMP contains a medical

device, otherwise select 'No'.
For more information on the CE Mark: http://en.ce-isareti.com/default.asp
Click in the free text field and enter the name

and address of the notified body (up to 200
characters).
Select 'Yes' if the device contains material of
Biological Origin.
Select 'Yes' if the device contains a Scaffold.
Does the device contain extracellular matrices
(ECM)?
Is it another type of Device?
Click in the free text field and enter the type of
device, if it does not fall under D.7.4.2-D.7.4.4
If you are using one or more Placebo IMPs use
'add placebo'. Complete for each different
Placebo used.
This is a calculated field
and is not entered by
the user.
The following applies for one Placebo. Click
'Done' button then click 'add placebo' for each
different Placebo.
Format: PLnn
Click the drop-down list, then select the
pharmaceutical form of the placebo to be used
in the Clinical Trial.
NOTE: This field
Click the drop-down list, then select the Route
repeats. There may be of Administration of the placebo to be used in
more than one Route of the Clinical Trial.
Administration for one
placebo
hich this is the placebo rows

Product sequence
number (row 31) for the
products (IMPs) for
which this is a placebo.
Tick box by each listed
product to select those
for which this placebo is
a replacement. These
were radio buttons
before 3.0.1
Tick box by each listed product to select those

for which this placebo is a replacement. Note:
This is a MANDATORY FIELD if D.8.1 is
answered 'Yes'.
Tick box by each listed product to select those
for which this placebo is a replacement. Note:
This is a MANDATORY FIELD if D.8.1 is
answered 'Yes'.
James Lenoel:
Reference to
Community valid for 3rd
Country? Or need
tailored text?
Note: This is a MANDATORY FIELD and if it is

'Yes', D.8.5.2.1 should be completed.
composition of the placebo, including all major
ingredients (up to 200 characters).
This section records the Sites responsible for
final Qualified Person (QP) Release of the
IMPs prior to distribution to Investigators. Click
'add responsible site'.
Or answer D.9.1 in cases where the IMP has a
marketing authorisation in EU and is sourced
from the EU market and is used in the trial
without modification (e.g. not overencapsulated) and the packaging and labelling
are carried out for local use only as per article
9.2 of Directive 2005/28/EC.
sponsible Site needs to be identified

Click the tick box if ALL the conditions above
are met.
Product sequence
number for the products
(IMPs) for which no
responsible site is
required
Click the associated tick box if ALL the

conditions for not requiring a responsible site in
the Community for the certification of the
finished IMP (qualified person) are met.
Product sequence
number for the products
(IMPs) for which no
responsible site is
required
Click the associated tick box if ALL the

conditions for not requiring a responsible site in
the Community for the certification of the
finished IMP (qualified person) are met.
Where products are to be identified under

D.9.2, all sub-questions (D.9.2.1 to D.9.2.4) are
MANDATORY, except post code when none
exists for that address.
Click the drop-down list, then select the
Responsible Site Role from the list of options.
Name of the
organisation within the
Community responsible
for the release of the
IMP. Each IMP in turn
needs to be referred to
and identified for ID
F.1.3
ICH A.3.1.2 Sender
Identifier has 60 and EV
Simple DB mahname
has 100 use the same
as EV.

the organisation responsible of the product
release for its use in the concerned clinical trial

Address)
Enter the street name and building name

and/or number, of the site responsible for
product release. (up to 120 characters).
As EV city field in
DD_MAH.

the town or city where the responsible site is
located (up to 50 characters).

Address)
Click in the free text field and enter the post

code of the responsible site location (up to 15
characters).
EUTCT ID of the
country.
Must be from the
EEA/MS list only
Click the drop-down list to select the country in

which the responsible site is located.
Change of meaning of
this field from 3.0.1

manufacturer's authorisation number (up to 100
characters). If there is no manufacturing
authorisation number but the site is authorised
enter 'Site authorised' this is applicable in
Click in the free text field and enter the reasons
some Member States (e.g. Germany) where no
why an authorisation was not given (up to 500
manufacturing authorisation number is issued.
characters).
hich this is the responsible site

Product sequence
number (row 31) for the
products (IMPs) for
which this is the
responsible site.
for which this is the responsible site
Click in the free text

field and enter the
manufacturer's authorisation
number (up to 100 characters).
If there is no manufacturing
authorisation number but the
site is authorised —
enter 'Site authorised' —
this is applicable in some
countries (e.g. Germany) where
no manufacturing authorisation
number is issued.
Scope, Type and Design of the Trial are on the

next screen.
Free text can be copy/pasted from a wordprocessed copy of the Protocol, but be brief as
long copies of protocol text are not required.
Click the 'Next' button at the bottom of the page
to move to the next sub-section..
Free text entry
Click in the free text field and enter: 1) In the

case of healthy volunteer trials, state 'healthy
volunteers' as well as the intended indication
for the product under development, which
should be provided in parentheses. 2) If the trial
is to be conducted on patients, only the name
of the disease, which is the indication for which
the IMP is administered, is required (up to 500
characters). Click the <Add Other Languages
icon/eudract-web/img/add.png> to add text in
another language than English.
Click in the free text field and include a

description of the medical condition in nonmedical language - e.g. Avian Influenza Virus A
(H5N1) might be described as Bird Flu (up to
500 characters). Click the <Add Other
Languages icon/eudract-web/img/add.png> to
add text in another language than English.
Should be a coded list, Click the drop-down list, then select the
if possible from EUTCT Therapeutic Area from the list of options. Note:
This list is based upon on one taken from the
Medical Subject Headings list (MeSH).
MeSH is the National Library of Medicine's
controlled vocabulary thesaurus. It consists of
sets of terms naming descriptors in a
hierarchical structure that permits searching at
various levels of specificity.
To add new MedDRA data, enter search details

for the MedDRA term and/or level. Alternatively
enter the classification code you wish to add.
Then click 'Search' button.
You should routinely use the level "LLT" (Lower
Level Term).
Click the adjacent check box to select found
terms from the Results list, then click 'Add
Selected' button to add them to the CTA.
Note: MedDRA is a registered trademark of
the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA)
MedDRA dictionary
version.
The version of MedDRA the term is from. It is

recommended, of course, that applicants use
terms from the latest version of MedDRA
wherever possible. For more information on
MedDRA see: http://www.meddramsso.com/
MedDRA level
Key to MedDRA hierarchical levels (highest
One of
to lowest): SOC (System Organ Class); HLGT
HLGT;HLT;LLT;PT;SOC (High Level Group Term); HLT (High Level
Term); PT (Preferred Term); LLT (Lowest Level
Term). For more information on MedDRA see:
http://www.meddramsso.com/
MedDRA code
Specify here the 8-digit numeric code of the

MedDRA term. For more information on
MedDRA see: http://www.meddramsso.com/
MedDRA term
Click in the free text field (on the right) and

enter the MedDRA term (or part of a term). You
may use the filter drop-down options to narrow
or widen your search look-up. (up to 120
characters). For more information on MedDRA
see: http://www.meddramsso.com/
SOC
A rare disease concerns a restricted number of

patients in the general population and shows
evidence of gravity (because it is lifethreatening, invalidating or serious and
chronic). The limit accepted in Europe is 1 /
2000 person affected by the disease.
If, in the view of the sponsor, the indication
investigated in the trial answers this definition,
KK. The previous
'Yes'. If not, the applicant should select
value wasselect
Y.
'No'.
Biz decision
- Do not
Display Note: Points to consider on the calculation and
reporting of the prevalence of a condition for
Orphan drug designation: COM/436/01.
Biz decision -Not to

display in EU-CTR.
Previously it was Y
Administrator:
display in EU-CTR.
Previously it was Y
value was Y.
Biz decision - Do not
Display

display in EU-CTR.
Previously it was Y
Administrator:
display in EU-CTR.
Previously it was Y

description of the main objectives of the trial, if
applicable (up to 1000 characters). The main
(primary) objectives of the trial should be
described in this section. The wording used
here should be consistent with the wording in
the protocol. Click the <add button icon> to add
text in another language than English.
Note: This is a MANDATORY FIELD.
Included within a single

text string (form
guidance). (DB
Guidance says repeat
as necessary)

description of the secondary objectives of the
trial, if applicable (up to 1000 characters). The
wording of the objective(s) mentioned here
should be consistent with the wording in the
protocol. Click the <add button icon> to add
Note: This is a MANDATORY FIELD.
Field added at 3.0.1
If a sub-study is planned and if this sub-study is

taking place in the Member State concerned by
the application, select 'Yes'. If not, select 'No'.
Note: A sub-study, or ancillary study, is a study
performed on a sub-group of the subjects
included in the clinical trial. For example, a
pharmacokinetics or pharmacogenetic substudy may include a sample of the patients
participating in the clinical trial.
Field added at 3.0.1
Click in the free text field and include the details

of each sub-study (up to 4000 characters). If a
sub-study does not have a title, the nature of
the sub-study should be entered here instead
of a title (for example: pharmacogenomic
study).
Note: This is a mandatory field if there is a substudy planned.
If a sub-study is planned and if

this sub-study is taking place in
the country concerned by the
application, select 'Yes'. If not,
select 'No'. Note:
A sub-study, or ancillary study,
is a study performed on a subgroup of the subjects included
in the clinical trial. For example,
a pharmacokinetics or
pharmacogenetic sub-study
may include a sample of the
patients participating in the
clinical trial.

text string (form
guidance). (DB
as necessary)
Click in the free text field and list the details of

the most important reasons for the inclusion of
subjects in the clinical trial (up to 5000
characters). Click the <add button icon> to add
Note: This is a mandatory field.

text string (form
guidance). (DB
as necessary)
Click in the free text field and list the details of

the most important reasons for exclusion of
subjects from the clinical trial from among the
exclusion criteria described in the protocol (up
to 5000 characters). Click the <add button
icon> to add text in another language than
English.
Warning: Exclusion criteria should not be
described as the contrary of the inclusion
criteria listed in the free text field E.3.
Warning: The principal exclusion criteria should
not be mistaken for the criteria of study
termination or treatment halt.
Note: This is a mandatory field.
ator:
a single
Click in the free text field and list the primary
"Note: for TrialsIncluded
loaded inwithin
the system
before
stringread:
(form
arch 2011 this text
question
Women of end points of the clinical trial (up to 5000
g potential and
did not include the words characters).
not
guidance).
aception. TheRepeating
answer should therefore beWarning: The primary end point(s) should not
in that context, depending on when the be mixed with the objectives described in the
n was entered in the system (see start date)
section E.2.1. For example, for a trial which
rs on the query returned page."
objective is to evaluate the efficacy of a

treatment for hypercholesterolemia, the primary
end point could be a 20% decrease of the
cholesterol level. Click the <add button icon> to
Linked to each endpoint Click in the free text field and include a time
point for each of the primary end points detailed
in the section above (up to 800 characters).
Click the <add button icon> to add text in
another language than English.
Included within a single Click in the free text field and list the secondary
text string (form
end points of the clinical trial (up to 5000
guidance). Repeating
Warning: The secondary end point(s) should
not be mixed with the objectives described in
the section E.2.1.
Linked to each endpoint Click in the free text field and include a
timepoint for each of the secondary end points
detailed in the section above (up to 800
characters).
This is a MANDATORY section and each sub

question should be answered. Take into
account all the objectives of the clinical trial (not
only the primary objectives) and all the
assessments conducted during the clinical trial.
Tick more than one answer where applicable.
Select 'Yes' if the assessment of the IMP

efficacy as a diagnostic tool is within the clinical
trial objectives.
efficacy as a prophylactic pr preventive
intervention is within the clinical trial objectives.
efficacy as a therapeutic intervention is within
the clinical trial objectives.
Select 'Yes' if the study includes the
assessment of the safety of use of the IMP(s).
Select 'Yes' if the study assesses efficacy of the
IMP(s).
Select 'Yes' if the study will determine
pharmacokinetic parameter of the IMP(s).
pharmacodynamics of the IMP(s).
New field at 3.0.1

bioequivalence of two or more IMP(s).
Note: You should also mark 'Yes' in E.7.1.2.
Select 'Yes' if the study will determine doseresponse patterns of the IMP(s).
Select 'Yes' if the study will involve
pharmacogenetic research of the IMP(s).
pharmacogenomic research of the IMP(s).
pharmacoeconomic research of the IMP(s).
A trial scope other than those options available
above. If applicable then complete the free text
field E.6.13.1, below.
If line E.6.13 =Y then

specify here.
Click in the free text field and include details of

the trial scope, if E.6.13 is 'Yes' (up to 500

question should be answered. Identify the trial
type and phase (Phase I, II, III or IV). Emphasis
is placed on the ICH terms, human
pharmacology, and therapeutic exploratory,
therapeutic confirmatory and therapeutic use.
Please refer to the ICH E8 Note for Guidance
on general Considerations for Clinical Trials
(CHMP/ICH/291/95)
http://www.ema.europa.eu/pdfs/human/ich/029
15en.pdf in particular Table 1 and section 3.1.3
of that guidance. Note: If the trial is a
combination of more than one phase, select the
item most applicable to this trial. Explanation of
more than one phase trials should be given in
the covering letter.
Human pharmacology (Phase I) trials are the
first stage of testing in human subjects,
generally comprising a small group of healthy
volunteers. This phase includes trials designed
to assess the safety, tolerability,
pharmacokinetics, and pharmacodynamics of a
drug.
Note: If 'Yes' is selected, one item from E.7.1.1.
to E.7.1.3. should be marked 'Yes' too.
Select 'Yes if this trial is the first time the IMP

will be administered to humans. All the following
trials will not be considered as a first
administration to humans, in any country.
Select 'No' in the case of new generics or new
formulations of a medicinal product.
Warning: If the medicinal product has been
administered to humans in a previous trial, the
trial in the present application cannot be
considered a first administration to humans,
even if this trial is the first administration to a
new population or in a new indication. For
example, if previous trials have been conducted
on adults, and if the new trial is conducted on
children, this new trial (concerned by the
present application) cannot be considered the
first administration to humans.
Select 'Yes' for bioequivalence studies.

Note: You should also mark 'Yes' in E.6.8
James Lenoel:
Kuljit, note that there is
now divergence
between the 'feld help
text' in F.3.3.1 and
F.3.3.2.
Suggest that they may
need to be aligned.
On the basis of the feld
name, I would propose
'give birth'in the help
text for both since
conception is not
mutually inclusive of
having 'child bearing
potential' (i.e. some
female humans may be
able to conceive but not
be able to bear children
for a variety of reasons).
On this basis, I've
aligned with 'give birth'
rather than 'conceive'.
Please advise if this is
NOT OKAY. If not okay, I
assume that the feld
name will also need to
change to reflect that
the ability to conceive a
zygote.
Select 'Yes' if the phase 1 trial is neither a first

administration to humans nor a bioequivalence
study. Then complete the free text field 'Trial
type Other specification' below.
If line E.7.1.3 = Y then Click in the free text field and include details of
specify here
the trial type (up to 100 characters). Click the
<add button icon> to add text in another
language than English.
Therapeutic exploratory (Phase II) trials are
performed on larger groups and are designed
to assess how well an IMP works, as well as to
continue Phase I safety assessments in a
larger group of volunteers and patients.
Therapeutic confirmatory (Phase III) trials are
randomized clinical trials on large groups,
designed to be a definitive assessment of how
effective the drug is, in comparison with current
best alternative treatment.
Therapeutic use (Phase IV trials) involves
products with a marketing authorisation.
question should be answered.
If 'Yes' selected, E.8.1.1-E.8.1.7.1 applying to
the design of the trial should be completed. In a
controlled trial, the tested product is compared
to a reference treatment. The reference
treatment can be, for example, a placebo, a
product known to be effective, a surgical
procedure, or a different dose of the same
product.
If each subject in the trial is randomly assigned
to receive either the study treatment or a
placebo, select 'Yes'.
If the investigators and the subjects know which
treatment is actually given, select 'Yes'.
If the subjects (healthy volunteers or patients)
included in the trial don't know which treatment
they are given, select 'Yes'.
If the investigators and the subjects included in
the trial (healthy volunteers or patients) dont
know which treatment is given, select 'Yes'.
Select 'Yes', if the trial compares groups of
subjects concurrently, each group receiving
different dose or treatment.
Select 'Yes', if comparing two (or more)
treatments in which patients are switched to the
alternative treatment after a specified period of
time.
If there is another methodological characteristic

to the trial design, select 'Yes' and complete
free text field E.8.1.7.1 with a description.
specify here
the trial design (up to 100 characters). Click the
<add button icon> to add text in another
language than English.
Note: In a comparative trial, the investigational
product or marketed product is compared
against a standard drug (or placebo). The
standard (or reference) or placebo medication
is called the comparator drug. Ref:
("comparator drug." Pharmaceutical Medicine
Dictionary. Philadelphia: Elsevier Health
Sciences, 2001. Credo Reference. Web. 26
January 2010.). Warning: If the placebo is not
used as a comparator but is only used in the
trial in order to maintain the blind, the placebo
should not be considered as a comparator and
No should be ticked for the item E.8.2.2.
Select 'Yes' if the comparator drug is another

medicinal product.
Select 'Yes' if the comparator drug is a placebo.
Warning: If the placebo is only used in the trial
in order to maintain the blind, the placebo
should not be considered as a comparator and
'No' should be selected.
If the comparator is neither another medicinal

product nor a placebo, select 'Yes' here and
provide details in the free text field below.
specify here
comparators which are neither other medicinal
products nor placebos - e.g. A medical device,
a surgical procedure, the lack of treatment, a
different treatment schedule, different dosage
of the same product (up to 100 characters).
Click in the free text field and include the
number of treatment arms (groups) in the trial
Select 'Yes' if the trial is conducted in a single
centre (clinical trial site) in the Member State
concerned by the application.
Select 'Yes' if the trial is

conducted in a single centre
(clinical trial site) in the country
concerned by the application.
New field in 3.0.1
New field in 3.0.1
Select 'Yes' if the trial is conducted in multiple

sites in the concerned Member State. In this
case, the number of sites in the Member State
concerned should be entered in section
E.8.4.1, below.
Select 'Yes' if the trial is

conducted in multiple sites in
the concerned country. In this
case, the number of sites in the
country concerned should be
entered in section E.8.4.1,
below.

number of sites in the Member State concerned
where the trial will take place (up to 2
numbers).

field and include the number of
sites in the country concerned
where the trial will take place
(up to 2 numbers).
Select 'Yes' if the trial will be conducted in more

than one Member State of the EEA.
number of sites in the European Economic
Area where the trial is planned to take place
(up to 4 numbers). Note: Please include the
sites in the Member State concerned in your
total.
Trial involves Investigator Sites in at least one

Member State and at least one third country. A
third country means a country which is not a
Member State of the EU/EEA.
Applicant must select "Yes" or "No". Trial only
involves Investigator sites in third country. A
third country means a country which is not a
Member State of the EU/EEA.
Multi-select box with
clickable countries
sorted alphabetically
Any country in the
world.
To select one country, click the country and

then click 'Copy'.
To select more than one country, hold CTRL
then click the countries and then click 'Copy'.
To select all countries, click Copy All button.

number of sites outside the European
Economic Area where the trial is planned to
take place (up to 2 numbers).
New field in 3.0.1
Select 'Yes' if an independent data monitoring

committee will be used for this trial.
Click in the free text field and, if it is the last
visit of the last subject, enter 'LVLS'. If it is not
'LVLS', provide the definition and justification
(up to 500 characters). Click the <add button
English.

field and include the number of
sites, globally, where the trial is
planned to take place (3
numbers).
The duration should be measured from the 1st

inclusion until the last visit of the last subject
(LVLS).
Click in each field and enter relevant numbers
for years, months and days (up to 2 numbers
per field).
New field at 3.0.1
Click in each field and enter relevant numbers

for years, months and days (up to 2 numbers
per field). Note: E.8.9.2 should not be
answered in case the Clinical Trial takes place
in a single country (i.e. E.8.5 and/or E.8.6.1 are
answered 'No'.).
New field at 3.0.1
Anticipated date if recruitment not started, actual date otherwise
Anticipated date if
Enter the date on which recruitment of subjects
recruitment not started, for the trial is planned to commence in the MS
actual date otherwise
concerned in the following format: YYYY-MMDD. Alternatively, click the calendar and select
the start date.
Anticipated date if
Enter the date on which recruitment of subjects
recruitment not started, for the trial is planned to commence in all
actual date otherwise
countries in the following format: YYYY-MM-DD.
Alternatively, click the calendar and select the
start date. Note: E.8.10.2 should not be
answered if the clinical trial takes place in a
single country (i.e. E.8.5 and/or E.8.6.1 are
answered 'No'.).
If there are no subjects under 18 it is sufficient

to answer 'No' and then answer questions
relevant to adults and elderly.
If the trial population

includes subjects < 18
years:
A statement that this
clinical trial carried out
outside the EEA will be
conducted in
accordance with the
ethical requirements of
Directive 2001/20/EC
and includes measures
to minimise pain and
distress, as required in
the EEA.
If 'Yes' all fields from F.1.1.1. to F.1.1.6.should

be completed (e.g. If subjects aged 2 to 11 are
enrolled in the trial, select 'Yes' for F.1.1.5. and
'No' for F.1.1.1, F.1.1.2, F.1.1.3, F.1.1.4 and
F.1.1.6.).
.
Click in the field and enter relevant number of

subjects (up to 10 numerals).
Select 'Yes' if the subjects are unborn infants,
still in the womb.
Select 'Yes' if the subjects are not more than 37
weeks from their conception.

Select 'Yes' if the subjects are newborn babies
aged 0-27 days.
Select 'Yes' if the subjects are aged 28 days to
23 months.
Select 'Yes' if the subjects are aged 2 to 11
years.
years.

years.
Select 'Yes' if the subjects are aged 65 years or
more.
Select 'Yes' if the trial includes female subjects.

This is mandatory.
Select 'Yes' if the trial includes male subjects.
This is mandatory.
Select 'Yes' if the trial includes subjects in good

health. This is mandatory
Select 'Yes' if the trial includes subjects, who
are currently patients. This is mandatory.
New field at 3.0.1
Select 'Yes' if the trial includes subjects (healthy

volunteers or patients), who are considered to
be part of a vulnerable population (see ICH
GCP definition of 'Vulnerable Subjects' here. If
'Yes', please complete sections F.3.3.1F.3.3.7.1. This is mandatory.
The wording of the question changed from 10th
March 2011 to add the words 'not using
contraception'. Please select 'Yes' only if the
trial includes female subjects who have the
potential to conceive and are not using
contraception.
New field at 3.0.1
Select 'Yes' if the trial includes women subjects

who have the potential to give birth and are
using contraception.
Select 'Yes' if the trial includes women subjects

who are breastfeeding.
Select 'Yes' if an emergency situation, where
urgent care is needed for the patient and this
involves enrolment in the trial (for example:
myocardial infarction, or head injury).
Select 'Yes' if subjects who are incapable of

giving consent personally are to be enrolled in
the trial. For example:
Subjects incapable of giving consent for
physical or physiological reasons, or reasons
linked to their medical condition (e.g. coma,
mental disability and in accordance with
national requirements).
Subjects under age incapable of giving consent
personally.
Subjects with a condition which makes them
incapable of giving consent personally and who
need urgent care. In this last case, select 'Yes'
for F.3.3.5, above.
Note: This section is for subjects who are
vulnerable for reasons other than their age
alone. Children are already identified under
F.1.1, but institutionalised, or mentally
handicapped children should be mentioned
here.
If line F.3.3.6 = Y then

specify here

the groups of population subjects incapable of
giving consent. Click the <add button icon> to
Note: This section is for subjects who are
vulnerable for reasons other than their age
alone. Children are already identified under
F.1.1, but institutionalised, or mentally
handicapped children should be mentioned
here (up to 250 characters).
Select 'Yes' if other categories of vulnerable

subjects will be enrolled in the trial. For
example :
Subjects who are in prison
Subjects hospitalised without their consent.
If 'Yes', complete section F.3.3.7.1 by adding
details.
If line F.3.3.7 = Y then

specify here.

the other category of vulnerable populations
(up to 100 characters). Click the <add button
English.
The information entered in this section should
match the information presented in sections
E.8.3., E.8.4., E.8.5. and E.8.6.
The information entered in this

section should match the
information presented in
sections E.8.3 and E.8.4 where
applicable.

the planned number of subjects to be included
in the Member State to which the application is
submitted (up to six numerals).

field and include details of the
planned number of subjects to
be included in the country to
which the application is
submitted (up to six numerals).
Please note: F.4.2.1 and F.4.2.2 should not be

answered if the clinical trial takes places in a
single country (i.e. E.8.5 and/or E.8.6.1 are
answered 'No'.).
in the EEA (including the concerned Member
State) in total (up to six numerals).
Click in the free text field and

include details of the planned
number of subjects to be
included in the concerned
country in total (up to six
numerals).

in the entire world (up to six numerals).
post-trial treatment or care, if not already
provided in the protocol (up to 500 characters).
Complete the Investigator Sites in this Member

State only. At least one (the principal of a single
centre or coordinator of a multicentre trial)
should be added.
INnn
Selected by drop-down Click the drop-down list, then select the
list :
investigator's role from the available options.
The reporting of Other
Principal Investigators
is only for investigators
in the Member State
where the application is
made.
ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.
Complete the Investigator Sites

in this country only. At least one
(the principal of a single centre
or coordinator of a multicentre
trial) should be added.

ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.

investigator's middle name. The middle name is
not mandatory. Middle name refers to the
second given name and does not refer to any
part of the family name. For example, enter
Elizabeth for Ana Elizabeth (up to 100
characters).
Field lengths are as per Click in the free text field and include the
ICH A.3.1.3c, A.3.1.3d investigator's family name, which is also known
and A.3.1.3e Sender
as the surname.
Identifier.
investigator's qualifications (up to 50
characters).

Address)
As EV city field in
DD_MAH.
Address)
EUTCT ID of the
country.
Must be from the
EEA/MS list only

name.

are those of the Network contact mentioned in
section G.4.2.
section G.4.2.
section G.4.2.
Only central facilities should be completed who
supply services for at least this Member State.
The facility may be in this Member State,
another Member State or a 3rd Country.
Central Technical Facilities includes central
laboratories and central ECG or image
processing facilities.
Only central facilities should be

completed who supply services
for at least this country. The
facility may be in this country, a
3rd Country, or a Member State
of the EEA. Central
Technical Facilities includes
central laboratories and central
ECG or image processing
facilities.

ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.
ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.
The middle name is mandatory. Middle name

refers to the second given name and does not
refer to any part of the family name. For
example, enter Elizabeth for Ana Elizabeth

ICH A.3.1.3c, A.3.1.3d Use this field to record a functional role.
and A.3.1.3e Sender
Identifier.
Address)

name.

Address)
EUTCT ID of the
country.
This can be any country
in the world.
(10AN), extension
(5AN) Telephone
A.3.1.4f,g,h
respectively)

are those of the central technical facility contact
mentioned in section G.3.1. Please include the

Central technical facilities or Sponsors
subcontractor facilities should be detailed
where used, below.
Select 'Yes' if the CTF will provide routine

clinical pathology testing.
Select 'Yes' if the CTF will provide clinical
chemistry analysis or testing.
Select 'Yes' if the CTF will provide Clinical
haematology analysis or testing.
Select 'Yes' if the CTF will provide Clinical
microbiology analysis or testing.
Select 'Yes' if the CTF will provide
Histopathology analysis or testing.
Select 'Yes' if the CTF will provideSerology/
endocrinology analysis or testing.
Select 'Yes' if the CTF will provide Analytical
chemistry.
Select 'Yes' if the CTF will provide ECG
analysis/ review.
Select 'Yes' if the CTF will provide medical
image analysis/ review - X-ray, MRI, ultrasound,
etc.
Select 'Yes' if the CTF will provide Primary/
surrogate endpoint test.
Select 'Yes' if the services provided by a central
technical facility are not covered in the above
options. Then complete the free text field
below.
services provided by a central technical facility
epeating group
Include details of any Clinical Investigator
Network involved in the Clinical Trial (if
applicable).

ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.

ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.

Elizabeth

and A.3.1.3e Sender
Identifier.
Address)

name.

Address)
EUTCT ID of the
Select the relevant country from drop-down list.
country
in the world.
are those of the network contact mentioned in
section G.4.2. Please include the international
activities performed by the trial network (up to
2000 characters).
bcontracted facility information Repeating group

Only central CRO facilities supplying services
for at least this Member State should be
entered (not e.g. individual field-based CRAs).
The facility may be in this Member State,
another Member State or a 3rd Country
Note that the answer to question 'G.5.1 Has the
sponsor transferred any major or all the
sponsor's trial related duties and functions to
another organisation or third party'? will be filled
in automatically by the system once the details
of the first subcontractor have been entered.
Only central CRO facilities

supplying services for at least
this country should be entered
(not e.g. individual field-based
CRAs). The facility may be in
this country, another country or
a Member State of the EEA.
Note that the answer to
question 'G.5.1 Has the sponsor
transferred any major or all the
sponsor's trial related duties
and functions to another
organisation or third party?' will
be filled in automatically by the
system once the details of the
first subcontractor have been
entered.

ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.
ICH A.3.1.3c, A.3.1.3d
and A.3.1.3e Sender
Identifier.

Elizabeth

and A.3.1.3e Sender
Identifier.
Address)

name.

Address)
EUTCT ID of the
country
in the world..
(10AN), extension
(5AN) Telephone
A.3.1.4f,g,h
respectively)

are those of the subcontractor contact
mentioned in section G.5.1.2. Please include
the international or applicable area codes.

(Y/N)
There will be 10 options
with selection buttons
Select 'Yes' if the sponsor will delegate all tasks
and the option of Other of sponsor.
Select 'Yes' if the vendor will undertake

monitoring duties.
regulatory duties (e.g. preparation of
applications to CA and Ethics Committee).
investigator recruitment/selection duties.
treatment randomisation duties or duties
include the setup, maintenaince and operation
of automated Interactive Response systems,
like IVRS (voice), IWRS (internet/world wide
web based) or hybrid ones.
Select 'Yes' if the vendor will undertake Data
Management duties.
electronic data capture (EDC) duties.
Select 'Yes' if the vendor will undertake drug
safety duties that involve SUSAR reporting.
Select 'Yes' if the vendor will perform Quality
Assurance auditing.
Y/N New field at 3.0.1

statistical analysis.

Medical writing duties.
Select 'Yes' if the vendor will undertake other
duties subcontracted not mentioned above.
Click in the free text field and include other
duties performed by the subcontractor on
behalf of the sponsor, if not detailed in the
above options (up to 100 characters).
Complete the current status of the application
to this National Competent Authority at the time
of submission to the Ethics Committee.

Address)

name.
Town/city only. No
EV city field in
DD_MAH.
Address)
EUTCT ID of the
country.
Must be from the
EEA/MS list only
Enter the date on which the application was
submitted to the NCA concerned in the
following format: YYYY-MM-DD. Alternatively,
click the calendar and select the start date.
Drop-down list.
Select relevant option from drop-down list.
If line 241 = Given

Date format
YYYYMMDD

authorised by the NCA concerned in the
If line 243 = N
Click in the free text field and include reasons

for non-acceptance of NCA Authorisation (up to
1000 characters).
If line 243 = N Date

format YYYYMMDD.
Enter the date on which the application is

expected to be resubmitted to NCA in the
mmittee Information for transmission to the Ethics Committee

Address)

name.
Town/city only. No
EV city field in
DD_MAH.
Address)
EUTCT ID of the
country
Must be from the
EEA/MS list only
yyyymmdd

submitted to the Independent Ethics Committee
concerned in the following format: YYYY-MMDD. Alternatively, click the calendar and select
the start date.
Drop-down list.
yyyymmdd
Enter the date on which the Independent Ethics

Committee provided their opinion in the
If line 255 = N (not

favourable)

for non-favourable opinion from the
Independent Ethics Committee (up to 1000
characters).
If line 255 = N (not

Enter the date on which the application is
favourable) Date format expected to be resubmitted to Independent
YYYYMMDD.
Ethics Committee in the following format:
EUTCT ID of the
Select relevant third country from drop-down
country.
list.
Any country in the world
declaration page. The blank form only will be created for printing, but will be completed by hand. No information is transferred
signature below
mpetent Authority (as stated in Section C.1):
Please provide in capitals full name and

functional role of the applicant.
information to be appended to the paper application. The blank checklist will be created for printing, but will be completion by
declaration page. The blank form only will be created for printing, but will be completed by hand. No information is transferre
tion added to the database to Review the initial application.

Free text for the
Click in the free text field and include
comments of the MS in comments pertaining to the National
row 2.
Competent Authority view of this Clinical Trial
Application. Note: This data is not included on
This data is not included the CTA form and will be included with Section
on the application form N data (initial Review of Application).
and will be included with
Section N data (initial
Review of Application)
Click in the free text field and include a specific

National Clinical Trial Application number (up to
200 characters).
YYYYMMDD. Field
added although not in
database guideline

received by the National Competent Authority in
the following format: YYYY-MM-DD.
start date.
YYYYMMDD. This is
the date on which the
period specified in
article 9.4 of the
Directive 2001/20/EC,
commences. Field
agreed at Brussels
meeting 13th Feb.

received by the National Competent Authority in
the following format: YYYY-MM-DD.
start date.

for Grounds for Non-Acceptance (up to 12
numerals).
You may specify here additional explanation for
the Grounds for Non-Acceptance (up to 500
characters).
If there is an
amendment to the
protocol prior to
authorisation / no
notification of non
acceptance, then enter
the code number.
Click in the free text field and include Sponsor's

protocol amendment code number (up to 50
characters).
YYYYMMDD If there is
an amendment to the
request prior to
authorisation / no
notification of non
acceptance then enter
the date of the
amendment.
Enter the date on which the Sponsor protocol

amendment occurred in the following format:
If there is an
amendment to the
request prior to
authorisation / no
notification of non
acceptance, then enter
the code number.
Click in the free text field and include Sponsor's

request amendment code number (up to 50
characters).
YYYYMMDD
Enter the date on which the Sponsor's request

amendment occurred in the following format:
Select options from

drop-down box.
Select relevant option from drop-down box.
To select one reason, click the reason from the

list in the left hand window and then click
'Copy'.
To select more than one reason, hold CTRL
then click the reasons and then click 'Copy'.
To select all reasons, click Copy All button.
Text for additional
reasons

the reasons for the NCA Decision (up to 500
characters).
YYYYMMDD
Enter the date on which the NCA Decision was

made in the following format: YYYY-MM-DD.
start date.
The opinion can be

favourable or Notfavourable.
To select one reason, click the reason from the

list in the left hand window and then click
'Copy'.
To select more than one reason, hold CTRL
then click the reasons and then click 'Copy'.
To select all reasons, click Copy All button.
Text for additional
reasons

the reasons for the NCA Decision (up to 500
characters).
YYYYMMDD

Committee was given in the following format:
If yes indicate opinion

below.
Select the opinion from Select relevant option from drop-down box.
drop down box
YYYYMMDD

Committee opinion on the amendment was
given in the following format: YYYY-MM-DD.
start date.
Drop-down list

This field is mandatory.
amendment code number (up to 50
characters). This field is mandatory.
yyyymmdd
Enter the date on which the Amendment was

made in the following format: YYYY-MM-DD.
start date.
YYYYMMDD.
Enter the date on which the Amendment was

received in the following format: YYYY-MM-DD.
start date.
YYYYMMDD. Field
Enter the date on which the assessment related
added at meeting in
to the amendment began in the following
Brussels 13th Feb 2004 format: YYYY-MM-DD. Alternatively, click the
calendar and select the start date.
Three options dropdown list.

yyyymmdd

Committee opinion on the amendment
assessment was given in the following format:
Three option drop-down Select relevant option from drop-down box.

list
yyyymmdd
Enter the date on which the National

Competent Authority made their decision on the
amendment assessment in the following
format: YYYY-MM-DD. Alternatively, click the
Interruption or
Completion transaction This field is mandatory.
type
Completion 1
Premature End 2
Prohibition by the NCA
3
Restart 7
Suspension by the NCA
4
Temporary Halt 5
yyyymmdd.
Enter the date on which the trial ended in the

Question reworded
following Ad-hoc
working group meeting
13th Feb
Specify here the reason for trial interruption. If
there is no applicable option, you may specify it
in the next free-text field.
reasons for the trial halt if it differs from the
options in the previously completed drop-down
list (up to 2000 characters). This field is
mandatory if no reason were provided in the
drop-down list above.
Free text.

justification for the premature ending of the trial
(up to 2000 characters). This field is mandatory.
YYYYMMDD
Enter the date on which the final clinical study

report is expected in the following format:
YYYYMMDD
Enter the date on which the results are

expected in the following format: YYYY-MM-DD.
start date.
YYYYMMDD
Enter the date on which the final clinical study

report was received by the National Competent
Authority in the following format: YYYY-MM-DD.
start date.
Date on which trial is

Enter the date on which the global end of the
planned to end globally trial is expected in the following format: YYYYMM-DD. Alternatively, click the calendar and
select the start date.
Not entered but taken

by the systems as the
Inspection organisation
of the user from the
user's security record.
ISO 3166 country

description for the MS
to which the inspection
is recorded. This
information is not
entered here, but is
taken from the security
record of the user
recording the
information.
System generated
identifier for the
Inspection record.
System allocated consecutive number. Use the

drop-down filter to search for exact matches
(equals) or partial Ids (starts with).
Proprietary number created by the Inspector's

organisation.
Additional field added n Click in the free text field and include the all
addition to the
comments related to the Inspection (up to 4000
guidance.
characters).
Drop-down list with
three values
Date format YYYY-MMDD
Additional field added in
addition to the guidance

Enter the date on which the inspection of the
facility (site) is planned in the following format:
yyyy mm dd

facility (site) actually began in the following
yyyy mm dd

facility (site) actually ended in the following
whose site was
inspected.
Address)

name.
Town/city only in
database. As EV city
field in DD_MAH.
Address)
EUTCT ID of the
country.
Whole world list
Select from a dropdown Select relevant option from drop-down box.
list.
If the selection from row Click in the free text field and include details of
7 is Other, specify
the site type, if not available in the Inspection
here.
Site Type drop-down options list (up to 200
characters).
If Y then include CT
references rows 3 and 4
GP = General Practitoner
Phase I is the first stage of a clinical trial. It is to

ensure a treatment is safe for people to take,
rather than to try to treat a condition. These
trials are very small, (typically around 30
people), and usually involve healthy volunteers
or sometimes patients.
ECG = Electrocardiography
SUSAR = Suspected Unexpected Serious

Adverse Reactions
e-CRF = electronic Case Report Form
IVRS = Interactive Voice Response System

the site specification if not available in the
above list of Y/N options (up to 200 characters).
Select the outcome

form a dropdown list of
three possibilities
r Protocol Code Numbers may repeat.

yyyy-nnnnnn-cc
Case insensitive. No
Proprietary number created by the Sponsor's
spaces. Stored twice organisation.
once as lower case and
no spaces for speed of
search and check on
duplicates, once as
entered. As ICH A.2.3.2
Sponsor Study Number.
Name of sponsor
organisation.
Address)
Town/city only in
database.
Address)
EUTCT ID of the
country
Countries in the whole
world list.

name.
ffected by this inspection

y shown in the guidance as required for IMP Site inspections, however the option to add product information to a Clinical Trial
EU Clinical Trial Register UI

Text
EudraCT
Allow search
EudraCT Search
Alias
EEA Application
Third Country CT
Neil
M=Mandatory
Cordwell:
Neil Cordwell:
A=Applicant
Y=Yes
S=Substantial
If
M+=Mandatory
M=Mandatory
"Y"Clear
this
Required
feld
Is the
should
with
feld format
searchable
be cleared when
by theload
pu
Req
Req
Protocol Information
Member State Concerned
data.submissionOrg.
name
M=Minor
E=EMEA
N=Not
M/E=Mandatory
M+=Mandatory
required with
but either
formatneeds to be com
Neil Cordwell:
N=NCA
N/A=Not
O=Optional
If "Y" thisapplicable
feld should be cleared when loa
O+=Optional with format
R=Rule
Neil
N/A=Not Applicable
applicable
Cordwell:
Is the feld
available
to theCordwell:
Neil
public
for available to the public for Clinic
Is
the feld
Clinical
Trials
covered
N
by the
guideline
for
paediatric
trials
Neil Cordwell:
Can't enter decision number unless part of
Formatting P/nn/YYYY
EudraCT Number
eudract_number
Free
text.
Field
Neil
Cordwell:
size
Either
phone or email or both
changed
from
500 to
2000 at
3.0.1
Neil Cordwell:
Either phone or email or both
Title of the trial for lay people,

in easily understood, i.e. nontechnical, language
Name or abbreviated title of

the trial where available
As ICH
A.2.3.1
Study
Name.
As ICH
A.2.3.2
Sponsor
Study
Number.
The
sponsor
s
version
number
for this
protocol
YYYYM
MDD.
The
date of
the this
version
of the
sponsor
s
protocol
Sponsors protocol code

number
cta_sponsor_protoco
l_no
ISRCTN (International
Standard Randomised
Controlled Trial) Number
US NCT (ClinicalTrials.gov
registry) number
Format
ISRCTN
999999
99
O
Roughly,
NCT
number
s are 8
digits,
ascendi
ng and
correlat
ed with
registrati
on date.
WHO Universal Trial

Reference Number (UTRN)
Other Identifier - Identifier
More
specific
ally,
NCT000
00100 NCT000
06520
are
sequenti
al with
occasio
nal
random
gaps
(caused
Repeati
by
ng
as a
deletion
pair
s, with
identifier
errors,
etc...)
then we
got a
little
smarter
and
started
increme
nting
by
Repeati
13,
so
ng as a
NCT000
pair with
06526
name
and
after are
divisible
by 13
which
means a
one digit
error
is
noticed.
Trial is part of a Paediatric

Investigation Plan
EMA Decision number of

Paediatric Investigation Plan
Resubmis
First sub
cta_pip_decision_no
Format:
P/xxxx/y
yyy,
where
xxxx is a
sequenti
al
number
and
yyyy is
the year.
Sponsor Information
N/A
Name of Sponsor
l text should stand as

country drop-down:
b>Click the
o select relevant
b>Note: If an
ng for the drop-down
mouse over it and
n appears in a tooltip.
contact_organisation
_name
N/A
N/A
family_name
N/A
N/A
N/A
N/A
N/A
M
N/A
N
Country
country_name
M/E
M/E
M/E
N/A
N/A
N/A
family_name
country_name
N/A
N/A
N/A
N/A
N/A
M
N/A
N
Source(s) of Monetary or
Material Support for the clinical
trial:
M/E
M/E
M/E
N/A
N/A
N/A
providing support
Country
Contact point designated by

the sponsor for further
N/A
N/A
N/A
Functional name of contact

point
Address:
N/A
N/A
N/A
Street Address
Town/ city
Post code
Country
Telephone number
Fax number
E-mail
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
M
N/A
N/A
N
Neil Cordwell:
N
New feld for 3rd country
but only to includ
M/E
M/E
e the drop-down
or exact matches
ial Ids (starts with).
M/E
N/A
N/A
N/A
N/A
N/A
N/A
e the drop-down flter

act matches (equals)
arts with).
James Lenoel:
Note to DEV: Include a help tip for
Attachments, too.
N/A
N/A
N/A
O
O
James Lenoel:
Note to DEV: Include a help tip for Attachments, too.
N/A
N/A
N/A
N
N
James Lenoel:
Note to DEV: Include a help tip for
Attachments, too.
M+
M+
James Lenoel:
NC: Specifcation of this
feld states 12 numbers.
Is this correct, or a bug?
EUTCT ID
Category
Status of the IMP to be used in

the clinical trial
N/A
IMP to be used in the trial has

a marketing authorisation
N/A
Trade name
N/A
N/A
N/A
N/A
James Lenoel:
NC: Specifcation of this feld states 12 numbers. Is this correct, or a bug?
This is the EUTCT ID of the reasons (see line 601)
Name of the Marketing

Authorisation holder
James Lenoel:
No limit on characters defned
in DD. Review Sybase version of
EudraCT v8 in DEV.
Country which granted the

N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
M
N/A
N
The IMP has been designated

in this indication as an orphan
drug in the Community
Orphan drug designation

number
N/A
N/A
N/A

Product name
imp_name
N/A
R
Product code
imp_code
Pharmaceutical form
N/A
Specific paediatric formulation
N/A
N/A
N/A
R
N/A
erlink to MeSH:
nih.gov/mesh/
N/A
N/A
N/A
link to MedDRA website:

mation see:
ddramsso.com/
fnition as published by EMA at

a.europa.eu/htms/human/orphan
/ 10,000 (mathematically is the
0,000 is the "legal" defnition)
Kuljit Kandhari:
Change this to
Paediatric
Investigation? Check
with Fergus.
Routes of administration for

this IMP
defnition of Vulnerable
/ichgcp.net/?page_id=432
N/A
N/A
N/A
INN - Proposed INN
active_substance_in
n
CAS number
active_substance_cu
rrent_sponsor_code
active_substance_ot
her_descriptive_nam
e
EV
Substance
nk to referenced
PDF
in
ntation.
the following appears on

of the document: DATE FOR
OPERATION March 1998
Code
the following appears on

of the document: DATE FOR
OPERATION March 1998
Strength
N/A
N/A
N/A
Concentration unit
Concentration type
number
number
vide an agreedConcentration
ch phase of Clinical
vide an agreed defnition for

Clinical Trials. Concentration
The IMP contains an:
N/A
N/A
N/A
N/A
N/A
N/A
Active substance of chemical

origin
Active substance of biological/

biotechnological origin (other
than Advanced Therapy IMP
(ATIMP)
The IMP is a:
N/A
N/A
N/A
Advanced Therapy IMP

(ATIMP)
Somatic cell therapy medicinal

product
Gene therapy medical product
Tissue Engineered Product
Combination ATIMP (i.e. one

involving a medical device)
Committee on Advanced
therapies (CAT) has issued a
classification for this product
http://www.ema.europa.eu/htms/
general/contacts/CAT/CAT.html
CAT classification and

reference number
Combination product that

includes a device, but does
not involve an Advanced
Therapy
Radiopharmaceutical
medicinal product
Immunological medicinal
product (such as vaccine,
allergen, immune serum)
Plasma derived medicinal

product
Extractive medicinal product
Kuljit Kandhari:
Hima - Assume these
are combined felds if
so can we have one
feld, Years, Months,
days??
Recombinant medicinal
product
Kuljit Kandhari:
Hima - Assume these
are combined felds if
so can we have one
feld, Years, Months,
days??
Medicinal product containing

genetically modified organisms
N/A
N/A
N/A
Herbal medicinal product
Homeopathic medicinal
product
Another type of medicinal

product
Other medicinal product type
http://www.ema.europa.eu/pdfs/human/swp/2836707en.pdf
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
R
N/A
N/A
N
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
R
N/A
N/A
N
N/A
N/A
N/A
N/A
R
N/A
N/A
N
Trial has a placebo
N/A
N/A
N/A
N/A
N/A
N/A
Pharmaceutical form of the

placebo
Route of administration of the

placebo
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
E. General
Information on the
Trial
N/A
N/A
N/A
Medical condition or disease

under investigation
N/A
N/A
N/A
Medical condition(s) being

investigated
Medical condition in easily

understood language
cta_med_condition_i
n_lay_lang
Therapeutic area
controlled_term_des
cription
MedDRA Classification
cision -Not to
in EU-CTR.
usly it was Y
strator:
sion -Not to
in EU-CTR.
sly it was Y
Medical condition or disease

under investigation
N/A
N/A
N/A
Version
Level
R+
R+
Classification code
Term
System Organ Class
Condition being studied is a

rare disease
cision -Not to
in EU-CTR.
usly it was Y
strator:
sion -Not to
in EU-CTR.
sly it was Y

Main objective of the trial
N/A
M
N/A
N/A
M
Secondary objectives of the

trial
Trial contains a sub-study
Full title, date and version of

each sub-study and their
related objectives
N/A
N/A
N/A
Principal inclusion criteria
Principal exclusion criteria
End points
Primary end point(s)
N/A
M
N/A
N/A
M
Timepoint(s) of evaluation of
this end point
Timepoint(s) of evaluation of
this end point
Scope of the trial
N/A
N/A
N/A
Scope of the trial
N/A
N/A
N/A
Diagnosis
Prophylaxis
Therapy
Safety
Efficacy
Pharmacokinetic
Pharmacodynamic
Bioequivalence
Dose response
Pharmacogenetic
Pharmacogenomic
Pharmacoeconomic
Others
Other scope of the trial

description
N/A
N/A
N/A
Human pharmacology (Phase

I)
First administration to humans
James Lenoel:
? I've taken a guess.
Please confrm.
KK: We do not have a
section G.3 for third
country trials hence this
is not needed.
Other
Other trial type description
Therapeutic exploratory
(Phase II)
Therapeutic confirmatory
(Phase III)
Therapeutic use (Phase IV)
Design of the trial
N/A
N/A
N/A
Controlled
Randomised
Open
Single blind
Double blind
Parallel group
Cross over
Other
Other trial design description
Comparator of controlled trial
N/A
N/A
N/A
Other medicinal product(s)
Placebo
Other
Comparator description
Number of treatment arms in

the trial
The trial involves single site in

the Member State concerned
The trial involves multiple sites

in the Member State
concerned
Number of sites anticipated in

Member State concerned
The trial involves multiple

Member States
Number of sites anticipated in
the EEA
Trial involving sites outside the

EEA
Trial being conducted both
within and outside the EEA
N/A
M

completely outside of the EEA
The countries in which trial

sites are planned
Number of sites anticipated

outside of the EEA
Trial has a data monitoring

committee
Definition of the end of the trial

and justification where it is not
the last visit of the last subject
undergoing the trial
N/A
N/A
Initial estimate of the duration

of the trial
N/A
N/A
N/A
In the Member State

concerned
years
In the Member State

concerned
months
In the Member State

concerned
days
In all countries concerned by

the trial
years

the trial
months

the trial
days
Proposed date of start of recruitment
N/A
N/A
N/A
In the Member State

concerned
In any country
Population of Trial Subjects
N/A
N/A
N/A
Age Range
N/A
N/A
N/A
Trial has subjects under 18
Number of subjects for this

age range:
In Utero

age range:
Preterm newborn infants (up

to gestational age < 37 weeks)

age range:

age range:
Infants and toddlers (28 days23 months)

age range:

age range:
Adolescents (12-17 years)

age range:

age range:

age range:
Gender
Female
Male

Healthy volunteers
N/A
M
N/A
N/A
M
N/A
M
N/A
N/A
M
Patients
Specific vulnerable
populations
Women of childbearing
potential not using
contraception
Women of child-bearing
potential using contraception
Pregnant women
Nursing women
Emergency situation
Subjects incapable of giving

consent personally
Details of subjects
Others
Details of other specific

vulnerable populations
Planned number of subjects to

be included
In the member state
N/A
N/A
N/A
N/A
N/A
N/A
In the EEA
Plans for treatment or care

after the subject has ended
the participation in the trial (if it
is different from the expected
normal treatment of that
condition)
N/A
N/A
N/A
family_name
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
O
N/A
N/A
N
N/A
N/A
N/A
Networks to be involved in the

Trial
N/A
N/A
R
N/A
R
N/A
R
N/A
N/A
N/A
N/A
N/A
N/A
R
Network Country
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
O
N/A
N/A
N
N/A
N/A
N/A
N/A
R
N/A
N/A
N
N/A
O
N/A
N/A
N
N/A
R
N/A
N/A
N
N/A
R
N/A
N/A
N
N/A
O
N/A
N/A
N
N/A
R
N/A
N/A
N
Third Country in which the trial

was first authorised:
First Authorised 3rd Country
information is transferred from Section C1 or C2 to Section I of the pdf or in the database.
, but will be completion by hand.

o information is transferred from section C1 to section L of the pdf or in the database.
N - Review by the Competent Authority or Ethics Committee in the country concerned

O
Competent Authority Decision
Date of Competent Authority

Decision
Ethics Committee Opinion of

the trial application
Ethics Committee Opinion:

Reason(s) for unfavourable
opinion
Date of Ethics Committee

Opinion
Ethics Committee Opinion

where the application/protocol
has been revised after review
by the Competent Authority
Independent Ethics Committee

Opinion
P - End of Trial
O
Anticipated date availability of

results
yyyy-mm-dd
Date of the global end of the

trial
yyyy-mm-dd
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
N/A
N/A
N/A
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
NCA
N
N
NCA
N
N
N
N
N
ormation to a Clinical Trial Site Inspection is also included in the system.

O
NCA
NCA
Third Country CT
tory
well:
Neil Cordwell:
Kuljit:
datory
ntial
feld
tory
nt
uired
Is the
should
with
feld format
searchable
be cleared
when
by theloading
public an EEA CTA
3rdXML
country
fle for
felds
conversion to a 3rd Country CT XML fle.
Clear
datory
datory
uired with
but either
formatneeds to be completed
available in EU-CTR
well:
al
pplicable
feld
should be cleared when loading a 3rd Country CT XML fle for conversion to a EEA CTA XML fle.
nal with format
Applicable
applicable
Neil
Neil Cordwell:
Cordwell:
well:
D=
Date
Multilingual:
available to the public for Clinical Trials covered by
the Guideline
CB=Check
Box for "Article 57" trials
N=Not
required
DL=Dropdown
list
T=Text feld
T=Text
CT=Through Controlled Terms
Y/N=Yes/No
buttons
Y
UI=Through radio
User Interface
Y/N/NA=Yes/No/Not Applicable radio
buttons
well:
r decision number unless part of PIP
g P/nn/YYYY
well:
ne or email or both
well:
ne or email or both
N/A
N/A
N/A
Y
N/A
N/A
Y
N/A
Y
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Y
Kuljit Kandh
This rule doe
Removed in v
country Scre
well:
Y to include Authorised/Refused
for 3rd country but only
N/A
N/A
N/A
Y
N/A
Y
Y
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Y
Y
N/A
N/A
N/A
N/A
Y
Y
N/A
Y
Y
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Y
N/A
Y
N/A
Y
Y
N/A
Y
Y
Y
N/A
Y
N/A
N/A
Y
Y
Y
Y
N/A
Y
Y
Y
N/A
Y
N/A
Y
Y
Y
Y
Y
Y
N/A
N/A
N/A
N/A
N/A
N/A
Y
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Kuljit:
Kuljit:
Previously thisPreviously
was Y,
this was Y,
The change has
Thebeen
change has been
requested by requested
the biz so by the biz so
this feld is not
this feld is not
displayed in EU-CTR
displayed in EU-CTR
The change has

Thebeen
change has been
requested by requested
the biz so by the biz so
this feld is not
this feld is not
displayed in EU-CTR
displayed in EU-CTR
N/A
N/A
Y
Y
N/A
Y
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Y
Y
N/A
Y
Y
Y
Y
Y
Y
N/A
N/A
Y
N/A
Y
N/A
N/A
N/A
Y
N/A
Y
Y
Y
N/A
N/A
Y
N/A
Y
N/A
N/A
Y
N/A
Y
N/A
Y
N/A
Y
Y
N/A
Y
N/A
Y
N/A
Neil Cordwell:
Note repeating
Kuljit Kandhari:
This rule does not apply to 3rd country Screen. Field D.2.2.3.1
Removed in v8. The entire D.2.2. Section not needed for 3rd
country Screen (Removal of D.2.2 Section in v9).
Kuljit Kandhari:
This is a radio button
feature where user
chooses a value instead
of Y or N.
Kuljit Kandhari:
This is a radio button
feature where user
chooses a value instead
of Y or N.
Field ID
A
A.1
A.2
A.3
A.3.1
A.3.2
A.4.1
A.5.1
A.5.2
A.5.3
A.5.4
A.5.4
A.7
A.8
B
B.1.1
B.1.3.4
B.3.1/B.3.2
B.4
B.4.1
B.4.2
B.5
B.5.1
B.5.2
B.5.3
B.5.3.1
B.5.3.2
B.5.3.3
B.5.3.4
B.5.4
B.5.5
B.5.6
D.1.2./D.1.3
D.2
D.2.1
D.2.1.1.1
D.2.1.1.2
D.2.1.2
D.2.5
D.2.5.1
D.3
D.3.1
D.3.2
D.3.4
D.3.4.1
D.3.7
D.3.8
D.3.9.1
D.3.9.2
D.3.9.3
D.3.9.4
D.3.10
D.3.10.1
D.3.10.2
D.3.10.3
D.3.10.3
D.3.11
D.3.11.1
D.3.11.2
D.3.11.3
D.3.11.3.1
D.3.11.3.2
D.3.11.3.3
D.3.11.3.4
D.3.11.3.5
D.3.11.3.5.1
D.3.11.4
D.3.11.5
D.3.11.6
D.3.11.7
D.3.11.8
D.3.11.9
D.3.11.10
D.3.11.11
D.3.11.12
D.3.11.13
D.3.11.13.1
D.8
D.8.1
D.8.3
D.8.4
E
E.1
E.1.1
E.1.1.1
E.1.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.3
E.2
E.2.1
E.2.2
E.2.3
E.2.3.1
E.3
E.4
E.5
E.5.1
E.5.1.1
E.5.2
E.5.2.1
E.6
E.6.1
E.6.2
E.6.3
E.6.4
E.6.5
E.6.6
E.6.7
E.6.8
E.6.9
E.6.10
E.6.11
E.6.12
E.6.13
E.6.13.1
E.7
E.7.1
E.7.1.1
E.7.1.2
E.7.1.3
E.7.1.3.1
E.7.2
E.7.3
E.7.4
E.8
E.8.1
E.8.1
E.8.1.2
E.8.1.3
E.8.1.4
E.8.1.5
E.8.1.6
E.8.1.7
E.8.1.7.1
E.8.2
E.8.2.1
E.8.2.2
E.8.2.3
E.8.2.3.1
E.8.2.4
E.8.3
E.8.4
E.8.4.1
E.8.5
E.8.5.1
E.8.6
E.8.6.1
E.8.6.2
E.8.6.3
E.8.7
E.8.8
E.8.9
E.8.9.1
E.8.9.1
E.8.9.1
E.8.9.2
E.8.9.2
E.8.9.2
F
F.1
F.1.1
F.1.1
F.1.1.1
F.1.1.1.1
F.1.1.2
F.1.1.2.1
F.1.1.3
F.1.1.3.1
F.1.1.4
F.1.1.4.1
F.1.1.5
F.1.1.5.1
F.1.1.6
F.1.1.6.1
F.1.2
F.1.2.1
F.1.3
F.1.3.1
F.2
F.2.1
F.2.2
F.3
F.3.1
F.3.2
F.3.3
F.3.3.1
F.3.3.2
F.3.3
F.3.3.4
F.3.3.5
F.3.3.6
F.3.3.6.1
F.3.3.7
F.3.3.7.1
F.4
F.4.1
F.4.2
F.4.2.1
F.4.2.2
F.5
G.4
G.4.1
G.4.3.4
H
H.4
H.4.1
N
List of fields that appear in EU-Clinical Trials Register
EU Clinical Trial Register UI Text

Protocol Information
Member State Concerned
EudraCT Number
Title of the trial for lay people, in easily understood, i.e. non-technical, language
Name or abbreviated title of the trial where available
Sponsors protocol code number
ISRCTN (International Standard Randomised Controlled Trial) Number
US NCT (ClinicalTrials.gov registry) number
WHO Universal Trial Reference Number (UTRN)
Other Identifier - Identifier
Trial is part of a Paediatric Investigation Plan
EMA Decision number of Paediatric Investigation Plan
Sponsor Information
Name of Sponsor
Country
Source(s) of Monetary or Material Support for the clinical trial:
Name of organisation providing support
Country
Contact point designated by the sponsor for further information on the trial
Functional name of contact point
Address:
Street Address
Town/ city
Post code
Country
Telephone number
Fax number
E-mail
IMP Role
Status of the IMP to be used in the clinical trial
IMP to be used in the trial has a marketing authorisation
Trade name
Name of the Marketing Authorisation holder
Administrator:
This feld is also called
'category'
Country which granted the Marketing Authorisation

The IMP has been designated in this indication as an orphan drug in the Community
Orphan drug designation number
Product name
Product code
Pharmaceutical form
Specific paediatric formulation
Routes of administration for this IMP
INN - Proposed INN
CAS number
EV Substance Code
Strength
Concentration unit
Concentration type
The IMP contains an:
Active substance of chemical origin
Active substance of biological/ biotechnological origin (other than Advanced Therapy
IMP (ATIMP)
The IMP is a:
Advanced Therapy IMP (ATIMP)
Somatic cell therapy medicinal product
Gene therapy medical product
Tissue Engineered Product
Combination ATIMP (i.e. one involving a medical device)
Committee on Advanced therapies (CAT) has issued a classification for this product
CAT classification and reference number
Combination product that includes a device, but does not involve an Advanced
Therapy
Radiopharmaceutical medicinal product
Immunological medicinal product (such as vaccine, allergen, immune serum)
Plasma derived medicinal product
Extractive medicinal product
Recombinant medicinal product
Medicinal product containing genetically modified organisms
Herbal medicinal product
Homeopathic medicinal product
Another type of medicinal product
Other medicinal product type
Is a Placebo used in this Trial?
Pharmaceutical form of the placebo
Route of administration of the placebo
General Information on the Trial
Medical condition or disease under investigation
Medical condition(s) being investigated
Medical condition in easily understood language
Therapeutic area
MedDRA Classification
Medical condition or disease under investigation
Version
Level
Classification code
Term
System Organ Class
Condition being studied is a rare disease
Main objective of the trial
Secondary objectives of the trial
Trial contains a sub-study
Full title, date and version of each sub-study and their related objectives
Principal inclusion criteria
Principal exclusion criteria
End points
Primary end point(s)
Timepoint(s) of evaluation of this end point
Timepoint(s) of evaluation of this end point
Scope of the trial
Diagnosis
Prophylaxis
Therapy
Safety
Efficacy
Pharmacokinetic
Pharmacodynamic
Bioequivalence
Dose response
Pharmacogenetic
Pharmacogenomic
Pharmacoeconomic
Others
Other scope of the trial description
Human pharmacology (Phase I)
First administration to humans
Other
Other trial type description
Therapeutic exploratory (Phase II)
Therapeutic confirmatory (Phase III)
Therapeutic use (Phase IV)
Design of the trial
Controlled
Randomised
Open
Single blind
Double blind
Parallel group
Cross over
Other
Other trial design description
Comparator of controlled trial
Other medicinal product(s)
Placebo
Other
Comparator description
Number of treatment arms in the trial
The trial involves single site in the Member State concerned
The trial involves multiple sites in the Member State concerned
Number of sites anticipated in Member State concerned
The trial involves multiple Member States
Number of sites anticipated in the EEA
Trial involving sites outside the EEA
Trial being conducted both within and outside the EEA
Trial being conducted completely outside of the EEA
If E.8.6.1 or E.8.6.2 are yes, specify the regions in which trial sites are planned
Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last visit of the last
subject undergoing the trial
Initial estimate of the duration of the trial
In the Member State concerned
years
months
days
In all countries concerned by the trial
years
months
days
Population of Trial Subjects
Age Range
Trial has subjects under 18
Number of subjects for this age range:
In Utero
Preterm newborn infants (up to gestational age < 37 weeks)
Infants and toddlers (28 days-23 months)
Adolescents (12-17 years)
Gender
Female
Male
Healthy volunteers
Patients
Specific vulnerable populations

Women of childbearing potential not using contraception
Women of child-bearing potential using contraception
Pregnant women
Nursing women
Emergency situation
Subjects incapable of giving consent personally
Details of subjects incapable of giving consent
Others
Details of other specific vulnerable populations
Planned number of subjects to be included
In the member state
In the EEA
Plans for treatment or care after the subject has ended the participation in the trial (if
it is different from the expected normal treatment of that condition)
Investigator Networks to be involved in the Trial
Network Country
Committee Decision
Third Country in which the trial was first authorised:
First Authorised Third Country
Review by the Competent Authority or Ethics Committee in the country concerned
Competent Authority Decision
Date of Competent Authority Decision
Ethics Committee Opinion of the trial application
Ethics Committee Opinion: Reason(s) for unfavourable opinion
Date of Ethics Committee Opinion
End of Trial
End of Trial Status
Date of the global end of the trial
EU- CTR (Display fields if no data)

Is always there
Is always there
Always Display
Only if completed
Only if completed
Always Display
Only if completed
Only if completed
Only if completed
Only if completed
Only if completed
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Only if completed
Only if completed
Only if completed
Only if completed
Only if completed
Only if completed
Administrator:
Only if completed
This feld is also called
Always Display
'category'
Always Display
Only if completed
Only if completed
Only if completed
Always Display
Always Display
Only if completed
Only if completed
Always Display
Always Display
Always Display
Only
Only
Only
Only
Only
if
if
if
if
if
completed
completed
completed
completed
completed
Only if completed
Only if completed
Only if completed
Only if completed
Always Display
Always Display
Always
Always
Always
Always
Always
Display
Display
Display
Display
Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Only if completed
Always Display
Only if completed
Only if completed
Always Display
Only if completed
Only if completed
Only if completed
Only if completed
Only if completed
Only if completed
Only if completed
Always Display
Always Display
Always Display
Always Display
Only if completed
Always Display
Always Display
Always Display
Only if completed
Only if completed
Only if completed
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Only if completed
Always
Always
Always
Always
Always
Always
Always
Always
Display
Display
Display
Display
Display
Display
Display
Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Only if completed
Always Display
Always Display
Always Display
Only if completed
Only if completed
Always Display
Always Display
Only if completed
Always Display
Only if completed
Always Display
Always Display
Conditional (see comment on this cell)
Always Display
Always Display
Always Display
Always Display
Always Display
Only if completed
Only if completed
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Always Display
Always Display
Always Display
Always Display
Conditional Rule:
E.8.6.3 always displays
for 3rd Country. For EEA
Only displays if E.8.6.2
or E.8.6.1 is Yes.
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Always Display
Only if completed
Always Display
Only if completed
Always Display
Only if completed
Only if completed
Only if completed
Only if completed
Only if completed
Always Display
Always Display
Always
Always
Always
Always
Always
Display
Display
Display
Display
Display
Always Display
Only if completed
Notes: How the information needs to be displayed in EU-CTR.

There may be instances where we have complete data set or fields where no data is available.
The following explains the display of fields for detailed CTA View.
Is Always there = (Mandatory fields). This applies to fields that are mandatory hence should always be di
Always Display = Display if data is available or not available. If data is not available the field should still b
'Information not present in EudraCT' with the exception to Boolean Fields e.g. Radio button as this will alwa
Only if completed = Display if data is available, If no data, then the field shall not be displayed.
Conditional = See comment on the relevant cell.
Conditional Rule:
E.8.6.3 always displays
for 3rd Country. For EEA
Only displays if E.8.6.2
or E.8.6.1 is Yes.
European Medicines Agency

Networking and Communications
Revision History
DIR 2001-20-EC
Consignit Doc id: ED20xx
Revision History
Version
Who
When
v3.10
KK
2/17/2010
v3.11
v3.12
KK
KK
3/1/2010
3/17/2010
v3.13
KK
4/7/2010
v3.14
JL
4/13/2010
v3.15
KK
4/20/2010
v3.16
KK
5/3/2010
v3.17
JL
5/27/2010
KK
6/7/2010
6/18/2010
7/5/2010
v3.18
KK
JL
7/12/2010
v3.19
v3.20
KK
8/18/2010
7/30/2010
9/6/2010
9/17/2010
10/1/2010
v3.21
KK
11/11/2010
v3.22
KK
4/4/2011
KK
5/23/2011
6/17/2011
21st June 2011
v3.23
KK
27th June 2011

29th June 2011
04th July 2011
302309274.xls Revision History
409 of 412

Revision History
04th
04th
06th
14th
14th
18th
25th
v3.23
JL
July
July
July
July
July
July
July
DIR 2001-20-EC
2011
2011
2011
2011
2011
2011
2011
8/8/2011
8/8/2011
9/22/2011
v3.24
v3.25
KK
10/5/2011
10/27/2011
KO
12/19/2011
JL
1/4/2012
410 of 412

Revision History
DIR 2001-20-EC
What
Updated field D.2.1.1.1.1 EV Product code to (Field Type= alphanumeric and field length = 25)
Just below field 5.1.6 added text ''Enter the details of any duties/ functions subcontracted to this sponsor's subcontractor facility in th
Included the date format to 'H.3.3.3.2 If 'not accepted', give the eventual anticipated date of resubmission'
Corrected the field numbering for rows 540-543 and 555-558 (H.2.2.1 Address, H.2.2.1 Town/City, H.2.2.1 Post code, H.2.2.1 Countr
Updated field E.8.2.4 Number of treatment arms in the trial datatype from alphanumeric to a numeric field.
Completed fields from A.3 to A.8 to list if these are mandatory or optional
Updated Field E.8.2.4 - Field Length to 10
Updated field D.2.1.1.1.1 EV Product code required for 3rd Country
Added a row to include Field D.2.3 IMPD Submitted
Added Header for Section G and Section H
Added Header for Section E.3, E.4 and E.5
Removed Orange and Red colouring on the field items as it was not required
Added missing fields from DD Ver2.9 Section Q Inspection Trial Specific, Inspection system or facility specific
Added the original Search Alias column gone missing from v3.6
Updated Section D.5 Note FROM: If D.3.11.4 is 'Yes' then section D.6 is MANDATORY TO Note: If D.3.11.3.3 is 'Yes' then section D.6
Updated Section D.7 TO These questions are asked if you have answered 'Yes' at D.3.11.3.4. Removed Reference to D.3.11.4.
Field Numbering Change Section G.3 and Section G.5
Spelling correction from differenciated to Differentiated
Updated section G.4.1 to G.4.7 in line with FEAT6.2.1.41 for 3rd Country CTs
Made minor updates to field level help contents, based on review of content against the system in the development of the fieldsHelp.p
No changes made to the data. Removed sheets that were no longer required in the data dictionary
Added a new field H.4 to capture 3rd Country CT Information (Third Country in which the trial was first authorised)
Modified existing H.4 field to H.4.1 and changed the field name
Replaced E.1.2. EUTCT ID field to MedDRA SOC
Updated N, O, P, Q with ids (form ref v3 colum used for this) as specified by Trasys Greece and cross-checked same against latst code
The date format is described in the help text. Removed references to date format (yyyy/mm/dd) from Column E - EU Trial Screen Tex
Updates to the title of CTA Section A-H
Updated Section Q Inspections data from alphanumeric to type: numeric to align with change to other radio button fields.
Updated column H to include screen text for EU CTR. Updated column U - Fields searchable by Public in EU CTR
Updated column G Help Text
Reviewed and updated column G Help Text, whilst implementing changes to property file ids based on v3.18 updates (aka Spanish NC
Included Column to denote 3rd country fields available in detailed CTA view via EU-CTR
Revised column U following feedback from business for display of 3rd country fields in EU-CTR
Revised IEC Opinion Reasons Additional explanation so it is not displayed in EU-CTR
Updated Section P. Anticipated date of availability of results - In scope for V9 for display in EU-CTR
Updated Section N. Separate IEC Opinion for GNA so it is not displayed in EU-CTR
Updated Section N. IEC Opinion of Amendment so it is not displayed in EU-CTR
Added a sheet for detailed CTA View for display in EU-CTR
Updated Section N . IEC Opinion Reasons marked as Public as per Article 41 - Paediatric Trials.
Updated Section G3 and G.5 So only Organisation, Country, Telephone, Fax and Email fields are mandatory
Updated D.8.5.2 Help Text
Updated E.8.5.2 Help Text
Removed references to the core data set appearing in Section O and P
Updated the help text in D.2.6 From D.2.6.1 to D.2.6
Updated the help text in F.3.3.1
Updated the help text in A.8 PIP Decision number and changed the format to allow leading zero: P/xxxx/yyyy
Updated the help text in D.2
411 of 412

Revision History
DIR 2001-20-EC
Updated the feld label and help text on E.8.7 to include the word Independent
Updated the help text on D.3.6.1 and D.3.6.2 to 'Read only'
Updated the help text on A.8
Updated the help text on D.3.10.1 Concentration unit
Updated the help text on G.4
Updated the help text on E.8.9.2, E.8.10.2 and F.4.2
Updated help
the help
on A.2
D.2.(ECT-3179),
and D.2.1 A.5.3, A.8, D.2.1.1.1.1 (update EV address), update D.3.6.1.1 & D.3
Updated
texttext
felds:
selectedImps & selectedPlacebos (ECT-2921), E.8.7 (ECT-3071), E.8.9.2, E.8.10.2, F.4.2 (ECT-3124), F.3.3.1 (
redundant note),
Third Country help additions (question mark denotes check of text by BA/Business required): B.5.1 (?), Secti
D.2.1.2.1, D.2.2, D.3.3, D.9.2.5, E.2.3, E.8.3, E.8.4, E.8.4.1, E.8.5.1, E.8.6.4, F.4 (ECT-3149), F.4.1, F4.2.1, Se
Updated help text on D.3.6.1 And D.3.6.2 related to dose per day/total
Removed comment boxes for resolved questions B.51, D.2.1.2 and G.5 and amended help text for D.3.6.1 a
the help text body (i.e. replace " with ' in all instances). Additionally, to add punctuation to the specifed trun
Removed colouring in Pink for text felds that are no longer new and are implemented now in 8.1
Changes made to the 'EU CTR Detailed View' tab. Updated section header "Review by the Competent Autho
by the Competent Authority or Ethics Committee in the country concerned" (N. row 218)
Removed 'withdrawal' from "If an unfavorable opinion or withdrawal, give reasons for the unfavorable opinio
application" (N. row 221)
Removed "or Application withdrawal" from "Date of Ethics Committee Opinion or Application withdrawal" no
Added E.8.6.3 as this is now a public feld (E.8.6.3 row 160)
Changes made to the 'EudraCT Dictionary' tab to align EU Clinical Trial Register UI Text column with the late
header "Review by the Competent Authority or Ethics Committee in the countries concerned" to "Review by
concerned" (row 593); "Date of Competent Authority Decision or Application withdrawal" changed to "Date o
explanation of reasons If an unfavourable opinion is given or there is a withdrawal" changed to " Ethics Com
"Date of Ethics Committee Opinion or Application withdrawal" changed to "Date of Ethics Committee Opinio
412 of 412

EudraCT Protocol Related Data Dictionary

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EudraCT Protocol Related Data Dictionary

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Neil Cordwell:

For EudraCT Form

Full title of the trial

Lay person title

Title of the trial for lay

Sponsor protocol code

Sponsors protocol code

Sponsor's protocol date

Date of latest change of

Other Identifier Name

Other Identifier Identifier

Trial part of a PIP

Is the trial part of a

PIP Decision number

EMEA Decision number

B.1 and B.3

B.1 and B.3

Sponsor Contact Given

Sponsor Contact Middle

Sponsor Contact Family

Sponsor Post Code

B.3.1 and B.3.2

Status of the sponsor

then select 'Continue'

Legal Rep Organisation Name of organisation

Legal Rep Contact

Legal Rep Middle name Middle name

Legal Rep Family Name Family name

Legal Rep Address

Legal Rep Town/City

Legal Rep Post Code

Legal Rep Country

Legal Rep Telephone

Legal Rep Fax

Legal Rep Email

Source of Monetary or Source(s) of Monetary

Field removed EudraCT

End of Sponsor repeating group Rows

Request for Authorisation to Competent Authority

C.1.1, C.1.2 and C.1.1, C.1.2 CA Applicant Type

C.1.1 and C.1.2 and

Complete the details of

Name of contact person

CA Applicant Post Code Post code

CA Applicant Telephone Telephone number

Send XML copy

Do you want a copy of

XML copy email x5

XML copy is secure

Request for Opinion of the Ethics Committee

C.2.1 and C.2.2 and

Complete the details of

IEC Applicant Contact

Name of contact person

IEC Applicant Given

IEC Applicant Middle

IEC Applicant Family

IEC Applicant Address Address:

IEC Applicant Post

IEC Applicant Country

IEC Applicant Fax

IEC Applicant Email

Description of the Investigational Medicinal Product Repeating group

IMP sequence number