1.

A P PLI C A TIONS FOR INV E STI G A TIO N A L NEW DR U GS (IN D s )

(Reference: Append! I "f Sc#ed$%e & ' (" Dr$)s *nd C"s+e(cs R$%es, 1-./ )
0 D"c$+en(s re1$red (" 2e s$2+((ed S(*($s
'es N"
1 App%c*("n f"r (per+ss"n f"r +*n$f*c($re 3+p"r( 3c%nc*% (r*% &
p$rp"se s#"$%d 2e c%e*r%4 +en("ned)
5 N*+e "f (#e *pp%c*n(
6 N*+e "f (#e Ne7 Dr$)
*. C"+p"s("n "f (#e Ne7 Dr$)
2. D"s*)e F"r+
c. Pr"p"sed ndc*("n f"r (#e Ne7 Dr$)
. App%c*("n n F"r+ .. c"+p%e(e n *%% respec( d$%4 s)ned *nd s(*+ped
24 *$(#"r8ed pers"n "f (#e fr+
/ Tre*s$r4 C#*%%*n "f INR /9,999 (f"r P#*se I) "r INR 5/,999 (f"r
P#*se II 3 III)
: C"p4 "f ;*%d +*n$f*c($rn) %cense n F"r+ 5/35:.
- S"$rce "f 2$%< dr$).
19. C#e+c*% *nd P#*r+*ce$(c*% Inf"r+*("n
19.1 Inf"r+*("n "n *c(;e n)reden(s
10.1.1 Drug information (Generic name, Chemical name, or INN)
19.5 P#4sc"c#e+c*% D*(*
10.2.1 Chemical name and structure, Empirical formula, olecular
!eight.
10.2.2 "h#sical properties$% Description, &olu'ilit#, (otation, "artition
coefficient, Dissociation constant.
19.6 An*%4(c*% D*(*$% Elemental anal#sis, ass spectrum, N( spectra, I(
spectra, )* spectra, "ol#morphic identification.
19.. C"+p%e(e +"n")r*p# specfc*("n nc%$dn)$% Identification,
Identit#+,uantification of purities, Enantiomeric purit#, -ssa#.
19./ V*%d*("ns$% -ssa# method, Impurit# estimation method, (esidual
sol.ent+other .olatile impurities (/*I) estimation method.
19.= S(*2%(es S($des (for details refer -ppendi0 I1 of &chedule 2)$% 3inal
release specification, (eference standard characteri4ation, aterial safet#
data sheet
1
19.> D*(* "n F"r+$%*("n:? Dosage form, Composition, aster manufacturing
formula, Details of the formulation (Including inacti.e ingredients),
Inprocess ,ualit# control chec5, 3inished product specification, E0cipient
compati'ilit# stud#, *alidation of anal#tical method.
Comparati.e e.aluation !ith international 'rand(s) or appro.ed Indian
'rands, if applica'le$% "ac5 presentation, Dissolution, -ssa#, Impurities,
Content uniformit#, p6, 3orce degradation stud#, &ta'ilit# e.aluation in
mar5et intended pac5 at proposed storage conditions, "ac5ing
specifications, "rocess .alidation.
11 An+*% P#*r+*c"%")4 (as per -ppendi0 I* of schedule 2 ):
11.1 &ummar#
11.5 &pecific pharmacological actions
11.6 General "harmacological actions
11.. 3ollo!%up and supplemental safet# "harmacolog# &tudies
11./ "harmaco5inetics$ a'sorption, distri'ution, meta'olism, e0cretion
15 An+*% ("!c"%")4 d*(* (as per -ppendi0 III of schedule 2)$
15.1 Gener*% Aspec(s
15.5. S4s(e+c T"!c(4 S($des,
15.6 @*%e Fer(%(4 S($d4
15.. Fe+*%e Repr"d$c("n *nd De;e%"p+en(*% T"!c(4 S($des (for all
drugs proposed to 'e studied or used in !omen of child 'earing age)
15./ L"c*% ("!c(4 (as applica'le)
12.7.1 Der+*% ("!c(4
(for products meant for topical (dermal) application)
12.7.2 Oc$%*r ("!c(4
(for products meant for ocular instillation)
12.7.8. In#*%*("n ("!c(4
(conducted !ith the formulation proposed to 'e used .ia
inhalation route)
12.7.9 V*)n*% ("!c(4
(for products meant for topical application to .aginal mucosa)
12.7.7 P#"("*%%er)4 "r der+*% p#"("("!c(4
(re,uired if the drug or a meta'olite is related to an agent
causing photosensiti.it# or the nature of action suggests such a
potential)
12.7.: Rec(*% ("%er*nce (es(
(3or all preparations meant for rectal administration)
15.= Gen"("!c(4
15.> A%%er)enc(43A4persens(;(4
2
15.: C*rcn")enc(4
(Carcinogenicit# studies should 'e performed for all drugs that are
e0pected to 'e clinicall# used for more than : months as !ell as for
drugs used fre,uentl# in an intermittent manner in the treatment
of chronic or recurrent conditions. 6o!e.er, completed rodent
carcinogenicit# studies are not needed in ad.ance of the conduct of
large scale clinical trials, unless there is a special concern for the
patient population)
Rep"r(s "f f"%%"7n) ("!c(4 s($des s#"$%d 2e s$2+((ed *%"n) 7(#
c%nc*% (r*% *pp%c*("ns "f dfferen( P#*ses f"r INDs:
3
F"r P#*se I C%nc*% Tr*%s
&#stemic ;o0icit# studies
(i) &ingle dose to0icit# studies
(ii) Dose (anging &tudies
(iii) (epeat%dose s#stemic to0icit# studies of appropriate duration to
support the duration of proposed human e0posure.
ale fertilit# stud#
In%.itro genoto0icit# tests
(ele.ant local to0icit# studies !ith proposed route of clinical application
(duration depending on proposed length of clinical e0posure)
-llergenicit#+6#persensiti.it# tests (!hen there is a cause for concern or
for parenteral drugs, including dermal application)
"hoto%allerg# or dermal photo%to0icit# test (if the drug or a meta'olite is
related to an agent causing photosensiti.it# or the nature of action
suggests such a potential)
F"r P#*se II C%nc*% Tr*%s
"ro.ide a summar# of all the non%clinical safet# data (listed a'o.e)
alread# su'mitted !hile o'taining the permissions for "hase I trial, !ith
appropriate references.
In case of an application for directl# starting a "hase II trial % complete
details of the non%clinical safet# data needed for o'taining the permission
for "hase I trial, as per the list pro.ided a'o.e must 'e su'mitted.
(epeat%dose s#stemic to0icit# studies of appropriate duration to support
the duration of proposed human e0posure
In%.itro and In%.i.o genoto0icit# tests.
&egment II reproducti.e+de.elopmental to0icit# stud# (if female patients
of child 'earing age are going to 'e in.ol.ed)
F"r P#*se III C%nc*% Tr*%s
"ro.ide a summar# of all the non%clinical safet# data (listed a'o.e)
alread# su'mitted !hile o'taining the permissions for "hase I and II
trials, !ith appropriate references.
In case of an application for directl# initiating a "hase III trial % complete
details of the non%clinical safet# data needed for o'taining the
permissions for "hase I and II trials, as per the list pro.ided a'o.e must
'e pro.ided.
(epeat%dose s#stemic to0icit# studies of appropriate duration to support
the duration of proposed human e0posure
(eproducti.e+de.elopmental to0icit# studies
In%.itro and In%.i.o genoto0icit# tests.
&egment I (if female patients of child 'earing age are going to 'e
in.ol.ed), and
&egment III (for drugs to 'e gi.en to pregnant or nursing mothers or
4
!here there are indications of possi'le ad.erse effects on foetal
de.elopment).
Carcinogenicit# studies (!hen there is a cause for concern or !hen the
drug is to 'e used for more than : months).
16 A$+*n 3 C%nc*% p#*r+*c"%")4 (P#*se I) nc%$dn) s$++*r4 "f (#e s($d4
*nd rep"r(s
16.1 &ummar#
16.5 &pecific "harmacological effects
16.6 General "harmacological effects
16.. "harmaco5inetics, a'sorption, distri'ution, meta'olism, e0cretion
16./ "harmacod#namics + earl# measurement of drug acti.it#
1. T#er*pe$(c e!p%"r*("r4 (r*%s (P#*se II)
1..1 &ummar#
1..5 &tud# report(s) as gi.en in -ppendi0 II
1/ T#er*pe$(c c"nfr+*("r4 (r*%s (P#*se III)
1/.1 &ummar#
1/.5 Indi.idual stud# reports !ith listing of sites and In.estigators.
1= Spec*% S($des
1=.1 &ummar#
1=.5 <io%a.aila'ilit# + <io%e,ui.alence
1=.6 /ther studies e.g. geriatrics, paediatrics, pregnant, or nursing !omen.
1> Re)$%*("r4 s(*($s n "(#er c"$n(res:?
1>.1 C"$n(res 7#ere (#e dr$) s
1=.1.1 ar5eted
1=.1.2 -ppro.ed
1=.1.8 -ppro.ed as IND
1=.1.9 >ithdra!n, if an#, !ith reasons.
1>.5 (estrictions on use, if an#, in countries !here mar5eted + appro.ed.
1>.6 3ree sale certificate or C/"", as appropriate.
1: Prescr2n) Inf"r+*("n:?
1:.1 "roposed full prescri'ing information.
1- S*+p%es *nd Tes(n) Pr"("c"%3s
1-.1 &amples of pure drug su'stance and finished product (an e,ui.alent of
70 clinical doses, or more num'er of clinical doses if prescri'ed '# the
?icensing -uthorit#), !ith testing protocols, full impurit# profile and
release specifications.) (;o 'e su'mitted to the la'orator# as directed '#
the ?icensing -uthorit#)
5
59. STR U CT U RE, C O NTEN T S A ND FO R @ A T FOR CLI N IC A L T R I A L P ROTOCOL
(Reference: Append!? B "f Sc#ed$%e & ' (" Dr$)s *nd C"s+e(cs R$%es, 1-./ )
0 D"c$+en(s re1$red (" 2e s$2+((ed S(*($s
'es N"
1.
;itle "age
2.
;a'le of Contents
8.
&tud# /'@ecti.e(s) (primar# as !ell as secondar#) and their logical
relation to the stud# design.
9. &tud# Design
7. &tud# "opulation
:. &u'@ect Eligi'ilit# % Inclusion Criteria and E0clusion Criteria
=. &tud# -ssessments
A. &tud# ;reatment
B. -d.erse E.ents
10. Ethical Considerations
11. &tud# onitoring and &uper.ision
12. &tud# onitoring and &uper.ision
18. In.estigational "roduct anagement
19.
Data -nal#sis
17. )nderta5ing '# the In.estigator as per -ppendi0 *II of &chedule 2$%
(Ethics Committee should 'e of same area !here the site is located and details of
the committee should 'e mentioned).
6
1:. Inf"r+ed C"nsen( D"c$+en(s:? "atient Information &heet ("I&) +
Informed consent form (IC3) as per re.ised -ppendi0 * of &chedule 2
including the follo!ing clauses.
-. &tatement descri'ing the financial compensation and medical
management as under$%
a) In the e.ent of an in@ur# occurring to the clinical trial su'@ects,
such su'@ects shall 'e pro.ided free medical management as
long as re,uired.
') In the e.ent of a trial related in@ur# or death, the sponsor or his
representati.e, !hosoe.er has o'tained permission from
licensing authorit# for conduct of clinical stud# shall pro.ide
financial compensation for the in@ur# or death.
<. In serial no. 02 of an -ppendi0 *, the follo!ing shall 'e included$
-ddress of the su'@ect$
Cualification$
/ccupation$ &tudent+&elfDemplo#ed+ser.ice+6ouse!ife+/ther.
("lease tic5 as appropriate)
-nnual income of &u'@ect$
Name and -ddress of nominee and his+her relation to the su'@ect. (
for the purpose of compensation in case of trial related death )
C. -fter the name of !itness occurring at the end, the follo!ing shall 'e
inserted$
ECop# of the patient information sheet and dul# filled IC3 shall 'e
handed o.er to the su'@ect or his+her attendantF
1=. )nderta5ing '# the &ponsor+&ponsors representati.e+applicant to the
licensing authorit# to pro.ide medical management and compensation in
case of clinical trial related in@ur# or death for !hich su'@ects are entitled
to compensation as re,uired under rule 122D-<(:).
1A. Declaration regarding financial status of the applicant .is%G%.is medical
management and compensation to 'e paid to the trial participants (in
case of in@ur# or death in clinical trial)
1B. ?ist of In.estigators including site address (es).
(a) ;rial site details (!hether it is e,uipped !ith super specialt# or multi%
specialt# facilities and emergenc# facilities !ith Institutional ethics
committee.
(') 3urnish details on the total num'er of trials 'eing underta5en currentl#
'# the proposed In.estigator.
20. Ethics Committee appro.als, if a.aila'le$%
(Institutional Ethics Committee should 'e in same area !here the site is
located).
21. -s per the protocol, !hether the su'@ects !ill recei.e the standard care.
(Gi.e declaration)
7
22. Details of the contract entered '# the sponsor !ith the
in.estigator+institutions !ith regard to financial support, amount of fees,
honorarium, pa#ments in 5ind etc. to 'e paid to the in.estigator.
In case no contract has #et 'een entered !ith an# In.estigator +
Institution, plan for financial support, fees, honorarium, and pa#ments in
5ind etc. to 'e paid to the in.estigator.
51. STRUCTURE, CONTENTS AND FOR @ AT F OR CLINIC AL S TUD ' REP ORTS
(Reference: Append!? II "f Sc#ed$%e & ' (" Dr$)s *nd C"s+e(cs R$%es, 1-./ )
0 D"c$+en(s re1$red (" 2e s$2+((ed S(*($s
'es N"
1.
;itle "age
5.
&tud# &#nopsis
6.
&tatement of compliance !ith the HGuidelines for Clinical ;rials on
"harmaceutical "roducts in India
..
?ist of -''re.iations and Definitions
/.
;a'le of contents
=.
Cop# of Ethics Committee appro.al
>.
&tud# ;eam
:.
Introduction
-.
&tud# /'@ecti.e
19.
In.estigational "lan
11.
;rial &u'@ects
15.
Efficac# e.aluation
16.
&afet# E.aluation
8
1..
Discussion and o.erall Conclusion
1/.
?ist of (eferences
N"(e:
1. -ll items mentioned a'o.e ma# not 'e applica'le to all drugs. ;he items not rele.ant to a
particular ne! drug should 'e mar5ed !ith ENot -pplica'le (N-)F.
2. In case the application is for clinical trial permission $%
(a) ade,uate chemical and pharmaceutical information should 'e pro.ided to ensure the
proper identit#, purit#, ,ualit# I strength of the in.estigational product, the amount of
information needed ma# .ar# !ith the "hase of clinical trials, proposed duration of trials,
dosage forms and the amount of information other!ise a.aila'le
(') In case of applications for protocol amendments of alread# appro.ed studies, applicants
should su'mit cop# of appro.al of protocol, amended ne! protocol, summari4ed list of all
the ne! changes incorporated along!ith @ustification + reasons for the change.
(c) E(#cs C"++((ee Appr";*%: Ethical appro.al should 'e o'tained from Ethics
Committee located in the same area !here the clinical trial site is located.
(d) ;he proposed clinical trial stud# centers should 'e geographicall# distri'uted in the
countr# and should also include clinical sites !hich ha.e their o!n Institutional Ethics
Committee.
9
5. C A EC C LI S T FOR A C CE P T A DILI T ' O F A P PLI C A TION PER T A N I NG TO
G R A N T OF PER @ IS SI O N TO I @ P ORT OR @ A N U F A C T U R E NEW
DR U GS G O I NG TO DE INT R ODU C ED FOR TAE FIRST T I @ E I N T A E
COUN T R' FOR S A LE OR TO U N DER T A CE CLI N IC A L TR I A LS
(Reference: Append! I "f Sc#ed$%e & ' (" Dr$)s *nd C"s+e(cs R$%es, 1-./ )
0 D"c$+en(s re1$red (" 2e s$2+((ed S(*($s
'es N"
1 App%c*("n f"r (per+ss"n f"r +*n$f*c($re 3+p"r(3c%nc*% (r*% &
p$rp"se s#"$%d 2e c%e*r%4 +en("ned)
5 N*+e "f (#e *pp%c*n(
6 N*+e "f (#e Ne7 Dr$)
*. C"+p"s("n "f (#e Ne7 Dr$)
2. D"s*)e F"r+
c. Pr"p"sed ndc*("n f"r (#e Ne7 Dr$)
. App%c*("n n F"r+ .. c"+p%e(e n *%% respec( d$%4 s)ned *nd s(*+ped
24 *$(#"r8ed pers"n "f (#e fr+
/ Tre*s$r4 C#*%%*n "f INR /9,999 (f"r P#*se I) "r INR 5/,999 (f"r
P#*se II 3 III)
: C"p4 "f ;*%d +*n$f*c($rn) %cense n F"r+ 5/35: *%"n) 7(# c"p4 "f
f"r+ 5-
- S"$rce "f 2$%< dr$).
19. C#e+c*% *nd P#*r+*ce$(c*% Inf"r+*("n
19.1 Inf"r+*("n "n *c(;e n)reden(s
10.1.1 Drug information (Generic name, Chemical name, or INN)
19.5 P#4sc"c#e+c*% D*(*
10.2.1 Chemical name and structure, Empirical formula, olecular
!eight.
10.2.2 "h#sical properties$% Description, &olu'ilit#, (otation, "artition
coefficient, Dissociation constant.
19.6 An*%4(c*% D*(*$% Elemental anal#sis, ass spectrum, N( spectra, I(
spectra, )* spectra, "ol#morphic identification.
19.. C"+p%e(e +"n")r*p# specfc*("n nc%$dn)$% Identification,
Identit#+,uantification of purities, Enantiomeric purit#, -ssa#.
19./ V*%d*("ns$% -ssa# method, Impurit# estimation method, (esidual
sol.ent+other .olatile impurities (/*I) estimation method.
19.= S(*2%(es S($des (for details refer -ppendi0 I1 of &chedule 2)$% 3inal
release specification, (eference standard characteri4ation, aterial safet#
data sheet
10
19.> D*(* "n F"r+$%*("n:? Dosage form, Composition, aster manufacturing
formula, Details of the formulation (Including inacti.e ingredients),
Inprocess ,ualit# control chec5, 3inished product specification, E0cipient
compati'ilit# stud#, *alidation of anal#tical method.
Comparati.e e.aluation !ith international 'rand(s) or appro.ed Indian
'rands, if applica'le$% "ac5 presentation, Dissolution, -ssa#, Impurities,
Content uniformit#, p6, 3orce degradation stud#, &ta'ilit# e.aluation in
mar5et intended pac5 at proposed storage conditions, "ac5ing
specifications, "rocess .alidation.
11 An+*% P#*r+*c"%")4 (as per -ppendi0 I* of schedule 2 ):
11.1 &ummar#
11.5 &pecific pharmacological actions
11.6 General "harmacological actions
11.. 3ollo!%up and supplemental safet# "harmacolog# &tudies
11./ "harmaco5inetics$ a'sorption, distri'ution, meta'olism, e0cretion
15 An+*% ("!c"%")4 d*(* (as per -ppendi0 III of schedule 2)
15.1 Gener*% Aspec(s
15.5. S4s(e+c T"!c(4 S($des,
15.6 @*%e Fer(%(4 S($d4
15.. Fe+*%e Repr"d$c("n *nd De;e%"p+en(*% T"!c(4 S($des (for all
drugs proposed to 'e studied or used in !omen of child 'earing age)
15./ L"c*% ("!c(4 (as applica'le)
12.7.1 Der+*% ("!c(4
(for products meant for topical (dermal) application)
12.7.2 Oc$%*r ("!c(4
(for products meant for ocular instillation)
12.7.8. In#*%*("n ("!c(4
(conducted !ith the formulation proposed to 'e used .ia
inhalation route)
12.7.9 V*)n*% ("!c(4
(for products meant for topical application to .aginal mucosa)
12.7.7 P#"("*%%er)4 "r der+*% p#"("("!c(4
(re,uired if the drug or a meta'olite is related to an agent
causing photosensiti.it# or the nature of action suggests such a
potential)
12.7.: Rec(*% ("%er*nce (es(
(3or all preparations meant for rectal administration)
15.= Gen"("!c(4
15.> A%%er)enc(43A4persens(;(4
11
15.: C*rcn")enc(4
(Carcinogenicit# studies should 'e performed for all drugs that are
e0pected to 'e clinicall# used for more than : months as !ell as for
drugs used fre,uentl# in an intermittent manner in the treatment
of chronic or recurrent conditions. 6o!e.er, completed rodent
carcinogenicit# studies are not needed in ad.ance of the conduct of
large scale clinical trials, unless there is a special concern for the
patient population)
16 A$+*n 3 C%nc*% p#*r+*c"%")4 (P#*se I) nc%$dn) s$++*r4 "f (#e s($d4
*nd rep"r(s
16.1 &ummar#
16.5 &pecific "harmacological effects
16.6 General "harmacological effects
16.. "harmaco5inetics, a'sorption, distri'ution, meta'olism, e0cretion
16./ "harmacod#namics + earl# measurement of drug acti.it#
1. T#er*pe$(c e!p%"r*("r4 (r*%s (P#*se II)
1..1 &ummar#
1..5 &tud# report(s) as gi.en in -ppendi0 II
1/ T#er*pe$(c c"nfr+*("r4 (r*%s (P#*se III)
1/.1 &ummar#
1/.5 Indi.idual stud# reports !ith listing of sites and In.estigators.
1= Spec*% S($des
1=.1 &ummar#
1=.5 <io%a.aila'ilit# + <io%e,ui.alence
1=.6 /ther studies e.g. geriatrics, paediatrics, pregnant, or nursing !omen.
1> Re)$%*("r4 s(*($s n "(#er c"$n(res:?
1>.1 C"$n(res 7#ere (#e dr$) s.
1=.1.1 ar5eted
1=.1.2 -ppro.ed
1=.1.8 -ppro.ed as IND
1=.1.9 >ithdra!n, if an#, !ith reasons.
1>.5 (estrictions on use, if an#, in countries !here mar5eted + appro.ed.
1>.6 3ree sale certificate or C/"", as appropriate.
1: Prescr2n) Inf"r+*("n:?
1:.1 "roposed full prescri'ing information. $ ;he prescri'ing information
(pac5age insert) shall comprise the follo!ing sections$ generic
nameJ compositionJ Ddosage form+s, indicationsJdose and methodof
administrationJ use in special populations (such as pregnant
!omen, lactating !omen, paediatric patients, geriatric patients
etc.)J contra% indicationsJ !arningsJ precautionsJ drug interactionsJ
undesira'le effectsJ o.erdoseJ pharmacod#namic and
pharmaco5inetic propertiesJ incompati'ilitiesJ shelf%lifeJ pac5aging
informationJ storage and handling instructions.
12
1- S*+p%es *nd Tes(n) Pr"("c"%3s
1-.1 &amples of pure drug su'stance and finished product (an e,ui.alent of
70 clinical doses, or more num'er of clinical doses if prescri'ed '# the
?icensing -uthorit#), !ith testing protocols, full impurit# profile and
release specifications.) (;o 'e su'mitted to the la'orator# as directed '#
the ?icensing -uthorit#)
59 Pr"p"sed Dr*f( spec+en "f (#e %*2e% *nd c*r("n. ;he drafts of la'el
and carton te0ts should compl# !ith pro.isions of (ules B: and B=.
51 If the stud# drug is intended to 'e imported for the purposes of
e0amination, test or anal#sis, the application for import of small ,uantities of
drugs for such purpose should also 'e made in 3orm 12.
13
55. STRUCTURE, CONTENTS AND FOR@AT FOR CLINICAL TRIAL PROTOCOL
(Reference: Append! ? B "f Sc#ed$%e & ' (" Dr$)s *nd C"s+e(cs R$%es, 1-./ )
0 D"c$+en(s re1$red (" 2e s$2+((ed S(*($s
'es N"
1.
;itle "age
2.
;a'le of Contents
8.
&tud# /'@ecti.e(s) (primar# as !ell as secondar#) and their logical
relation to the stud# design.
9. &tud# Design
7. &tud# "opulation
:. &u'@ect Eligi'ilit# % Inclusion Criteria and E0clusion Criteria
=. &tud# -ssessments
A. &tud# ;reatment
B. -d.erse E.ents
10. Ethical Considerations
11. &tud# onitoring and &uper.ision
12. &tud# onitoring and &uper.ision
18. In.estigational "roduct anagement
19.
Data -nal#sis
17. )nderta5ing '# the In.estigator as per -ppendi0 *II of &chedule 2$%
(Ethics Committee should 'e of same area !here the site is located and details
of the committee should 'e mentioned).
14
1:. Inf"r+ed C"nsen( D"c$+en(s:? "atient Information &heet ("I&) +
Informed consent form (IC3) as per re.ised -ppendi0 * of &chedule 2
including the follo!ing clauses.
D. &tatement descri'ing the financial compensation and medical
management as under$%
c) In the e.ent of an in@ur# occurring to the clinical trial su'@ects,
such su'@ects shall 'e pro.ided free medical management as
long as re,uired.
d) In the e.ent of a trial related in@ur# or death, the sponsor or his
representati.e, !hosoe.er has o'tained permission from
licensing authorit# for conduct of clinical stud# shall pro.ide
financial compensation for the in@ur# or death.
E. In serial no. 02 of an -ppendi0 *, the follo!ing shall 'e included$
-ddress of the su'@ect$
Cualification$
/ccupation$ &tudent+&elfDemplo#ed+ser.ice+6ouse!ife+/ther.
("lease tic5 as appropriate)
-nnual income of &u'@ect$
Name and -ddress of nominee and his+her relation to the su'@ect.
( for the purpose of compensation in case of trial related death )
3. -fter the name of !itness occurring at the end, the follo!ing shall 'e
inserted$
ECop# of the patient information sheet and dul# filled IC3 shall 'e
handed o.er to the su'@ect or his+her attendantF
1=. )nderta5ing '# the &ponsor+&ponsors representati.e+applicant to the
licensing authorit# to pro.ide medical management and compensation in
case of clinical trial related in@ur# or death for !hich su'@ects are entitled
to compensation as re,uired under rule 122D-<(:).
1A. Declaration regarding financial status of the applicant .is%G%.is medical
management and compensation to 'e paid to the trial participants (in
case of in@ur# or death in clinical trial)
1B. ?ist of In.estigators including site address (es).
(c) ;rial site details (!hether it is e,uipped !ith super specialt# or multi%
specialt# facilities and emergenc# facilities !ith Institutional ethics
committee.
(d) 3urnish details on the total num'er of trials 'eing underta5en
currentl# '# the proposed In.estigator.
20. Ethics Committee appro.als, if a.aila'le$%
(Institutional Ethics Committee should 'e in same area !here the site is
located).
21. -s per the protocol, !hether the su'@ects !ill recei.e the standard care.
(Gi.e declaration)
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22. Details of the contract entered '# the sponsor !ith the
in.estigator+institutions !ith regard to financial support, amount of fees,
honorarium, pa#ments in 5ind etc. to 'e paid to the in.estigator.
In case no contract has #et 'een entered !ith an# In.estigator +
Institution, plan for financial support, fees, honorarium, and pa#ments in
5ind etc. to 'e paid to the in.estigator.
56. Pr"("c"% "f D"e1$;*%ence s($d4 *%"n) 7(# Inf"r+ed C"nsen(
d"c$+en( *nd $nder(*<n) 24 In;es()*("r n c*se "f Or*% D"s*)e
F"r+s #*;n) s4s(e+*(c *2s"rp("n. In c*se "f 2"7*;er, E$s(fc*("n
s#"$%d 2e s$2+((ed.
5.. S(r$c($re, C"n(en(s *nd F"r+*( f"r C%nc*% S($d4 Rep"r(s:
(Reference: Append! II "f Sc#ed$%e & ' (" Dr$)s *nd C"s+e(cs R$%es, 1-./ )
0 D"c$+en(s re1$red (" 2e s$2+((ed S(*($s
'es N"
1.
;itle "age
5.
&tud# &#nopsis
6.
&tatement of compliance !ith the HGuidelines for Clinical ;rials on
"harmaceutical "roducts in India
..
?ist of -''re.iations and Definitions
/.
;a'le of contents
=.
Cop# of Ethics Committee appro.al
>.
&tud# ;eam
:.
Introduction
-.
&tud# /'@ecti.e
19.
In.estigational "lan
11.
;rial &u'@ects
16
15.
Efficac# e.aluation
16.
&afet# E.aluation
1..
Discussion and o.erall Conclusion
1/.
?ist of (eferences
N"(e:
1. -ll items mentioned a'o.e ma# not 'e applica'le to all drugs. ;he items not
rele.ant to a particular ne! drug should 'e mar5ed !ith ENot -pplica'le (N-)F.
5. -pplication for 'oth 'ul5 as !ell as formulation is re,uired to 'e su'mitted.
"roposal for grant of permission to manufacture onl# 'ul5 drug !ill 'e
considered after appro.al of itKs formulation.
6. In case the application is for clinical trial permission$
*. -de,uate chemical and pharmaceutical information should 'e pro.ided to
ensure the proper identit#, purit#, ,ualit# I strength of the in.estigational
product, the amount of information needed ma# .ar# !ith the "hase of
clinical trials, proposed duration of trials, dosage forms and the amount of
information other!ise a.aila'le.
2. In case of applications for protocol amendments of alread# appro.ed
studies, applicants should su'mit cop# of appro.al of protocol, amended
ne! protocol, summari4ed list of all the ne! changes incorporated
along !ith @ustification + reasons for the change.
c. Ethics Committee -ppro.al$ Ethical appro.al should 'e o'tained from
Ethics
Committee located in the same area !here the clinical trial site is located.
d. ;he proposed clinical trial stud# centres should 'e geographicall# distri'uted
in the countr# and should also include clinical sites !hich ha.e their o!n
Institutional Ethics Committee.
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