Potentially Unblinding Data

(PUBD)
October/November, 2013

PUBD - Overview
Introduction
How to recognize PUBD
Study Documents that identify PUBD
SOPs, MANs and FORMs
Processes
Roles
Potentially Unblinding events
Escalation and Notification
Next Steps
Consequences

Additional Information on Processes

For Internal Use Only. Amgen Confidential.

PUBD Introduction
In recent months there have been several potentially
unblinding events, including:
PUBD files in unrestricted folders (folders not properly restricted
or files placed on standard folders)
Potentially unblinding information in email to blinded staff (LDM)
Scrambled dataset with potentially unblinding information

Due to the criticality of maintaining a blind for a study and

the negative impacts affecting everyone, this
presentation has been constructed to reinforce proper
procedures to prevent exposure to PUBD.

For Internal Use Only. Amgen Confidential.

Consequences of unblinding - Data

integrity in question:
Exposed blinded study team member may have to be
removed from the trial
An extreme case could be regulatory authorities
rejecting data due to perceived bias during trial conduct
There is a zero tolerance KPI/SLA in place with FSP
vendors
Monetary consequences/penalty may be applied per signed WO

For Internal Use Only. Amgen Confidential.

How to Recognize PUBD

Potentially Unblinding Data (PUBD) is any information or data that is collected during
the conduct of an Amgen clinical trial and prior to initial lock of the database which
may:
Indicate or infer treatment assignment
Create bias in the conduct of a study
Impact the integrity of the clinical trial or data

Examples of unblinding data include:

Treatment assignments
Antibody (AB) results
Pharmacokinetics (PK) results
Laboratory data (e.g. Parameters that may infer treatment assignment)
Primary and secondary endpoint data
Vendor data (e.g. Imaging, bone scans)
Interactive Voice Response System (IVRS)/Interactive Web Response System (IWRS)
Pharmacogenomics

For Internal Use Only. Amgen Confidential.

Study Documents that Identify PUBD

The protocol is the primary source for defining PUBD and timing for
the unblinding of the data and treatment assignments. The following
documents will identify PUBD based on the protocol
BSM Plan
VSW/DTP
SOW/Charter
DSTW SSW Data Acquisition tab
Change Control Workbook
FORM-072344 Restricted or Potentially Unblinding Data Plan **

For Internal Use Only. Amgen Confidential.

SOPs, MANs and FORMs

SOP-018784 Folder Access Provisioning Process**

SOP-019691 Access to Restricted Data**

SOP-000684 Disclosing Treatment Assignments for Randomized Clinical Trials**

MAN-001579 Review of Potentially Unblinding Data**

MAN-001618 Creation, Approval & Maintenance of the Trial Integrity Document

(TID)**

MAN-001619 Accessing and Distributing Restricted Data for Amgen Clinical Trials**

FORM-072344 Restricted or Potentially Unblinding Data Plan **

UMAN-000275 and CG (external file handling)

FORM-008236 (signoff form for unblinding of result data)

MAN-000792 and CG (reporting, scrambling and SAS ECs)

MAN-001080 CG (placement of signoff form for unblinding of result data)

MAN-001082 and CG (Restriction set up in Rave for PUBD)

MAN-001084 and CG (Guidance on PUBD, restrictions)

For Internal Use Only. Amgen Confidential.

Systems Processes That May Handle

PUBD
Report generation requests:
Scrambling
CQA
LLR
Any CDR study report request
Treatment assignments

External Data
Transfer to external group
Loads to CTDB
Transfer to CTSHARED for Non-CTDB or for unblinded group review

Edit Checks outputs/listings

eCRF Design
Apply site entry/view restrictions for manually entered PUBD fields prior to
authorization for unblinding for the trial
For Internal Use Only. Amgen Confidential.

Systems Role authorized for PUBD

handling
As a rule, until the database is formally unblinded, the following systems
roles may access treatment assignments (limited to that required to perform
their role):
Lead Programmer
CSI or Technical Specialist
EDA/EDI Programmer
SAS Programmer
CDR Programmer
Study Designer

For Internal Use Only. Amgen Confidential.

When Potential Unblinding Risk Is

Identified Escalation and Notification

Any GSO DM TA and Systems (including FSPs) should notify the following oversight
roles immediately when a potential unblinding risk is identified:
Studys Amgen PL, FSP Ops Lead, Amgen Ops Lead

refer to the DM Systems ECS Portal for FSP and Amgen Ops Lead contacts

refer to GMAT for Amgen PL of the impacted study

Amgen Ops lead, FSP Ops Lead and Amgen PL will engage the reporter to establish
initial risk assessment confirming the reported risk is not a false alarm

If it is not a false alarm, Amgen PL will notify the following distribution list immediately
and within the same business day of identified incident with summary details and
provide daily updates until the issue is closed
Summary details to be included

Distribution List

1.
2.

Lead Data Manager

Amgen Sr Manager
Lead Programmer/CSI
Systems Operations Manager (Kim Wah Low)
FSP Governance & Oversight (Tab Hoda)
DM LT (Rob Tarney/Tina Harris, Taras Carpiac)
PUBD LT sponsor (Tina Harris)
PUBD Sr. Manager SME (David McGrath)
Cc: FSP Ops Lead, Amgen Ops Lead

3.
4.
5.
6.

Describe how was the risk identified

Describe the established start time of exposure
of risk
Include root cause if available
Include unblinding exposure analysis if available
Include corrective actions and status
Describe planned next steps (see next slide)

FSP and Amgen Ops Leads contact information

For Internal Use Only. Amgen Confidential.

10

When Potential Unblinding Risk Is

Identified Next Steps

FSP/Amgen Ops Lead is responsible to ensure

Remove data/outputs immediately post acknowledgement of risk if placed in incorrect or
unrestricted folder

Restricted folder should not include the following unix groups: cdmonc, cdmearlydev, cdmneph, cdmbone,
cdmgenmed, cdminflam

Request restriction of folder via Amgen FAST business owners** if not correctly restricted
For PUB data/outputs on CTSHARED,

Amgen Ops Lead requests a Varonis report for impacted file access audit history listed by user IDs, file
access action type, and timestamps within the established exposure timeframe via Amgen FAST Systems
Owner (Min Lee)

Amgen PL/Amgen Ops Lead perform unblinding exposure analysis using the Varonis report

If data loaded to Rave:

Inform LDM of plan to delete data

EDA to set BUI setting to delete if missing and load empty file. This will remove data and audit trail. Load
latest header data. (inactivate if missing would not remove audit trail).

If manually PUB data entered into Rave

LDM to request the site to blank out the PUD data value from EDC and provide appropriate reason for
change

Ops lead to escalate to the CSI and EDC Ops for a full assessment of exposure for the trial

Amgen PL is responsible for broader study team communication: Follow process on

Documenting Unblinding Without Previous Authorization: Inadvertent or Unauthorized Unblinding per SOP 000684

Per
confirmation
from Compliance,
For Internal
Use
Only. Amgen Confidential.

for11confirmed non-exposed event, do not need NTF

Overall Points to Remember/Follow

When Handling PUBD

IMPORTANT: Although users are able to create folders in CTSHARED, only

Amgen FAST Business Owners are allowed to create PUBD folders with
appropriate restrictions

Always verify the correct folder under the correct study prior to placing PUBD.

Always check restrictions on the folder prior to placing PUBD.

Immediately notify manager of any potentially unblinding event

Datasets with PUBD data include the words rslt or result

Restricted folder names include the words blinded or restricted

Never use production PUBD as test data

Update with dummy subjects or use entirely dummy data

Never send any datasets via email. Always place on ctshared and send the ctshared
file link to the requester

Never reference any details on PUBD records via email

Always review email body to ensure there in no PUB data before forwarding or
responding

For Internal Use Only. Amgen Confidential.

12

Additional Information on
Processes

SAS Edit Checks

against CTDB or non-CTDB data

Any testing should use non PUBD data (either dummy or nonblinded production data)

Confirm output location is accurate and the folder is restricted appropriately by manually
reviewing the folder properties

Programmer to confirm restrictions prior to running any checks (UAT or PROD)

PUBD Checks not to be added to automated scheduled until after the first PROD data is
received

After the first PROD data is received, the EDA will place the data in the correct location and
advise study team data transferred per current process

Study team will request SAS EC team to execute the SAS EC for the PUBD data for the first
time

Prior to first execution, programmer will confirm output directory in program one additional time

Programmer will confirm folder permissions one additional time

Programmer will execute PUBD checks and confirm that the output is as expected and in the
proper location

Programmer will add PUBD check to the automated schedule and the checks will run
automatically on future transfers

For Internal Use Only. Amgen Confidential.

14

External Data
SOW/Charter/etc
Vendor document specification should include blinded information
Covance DM will contact FSP EDA Ops Lead if any new SOWs drafts contain
blinded information for review.

This review is to verify that handling of the blinded data is achievable

Example is for repeat or unscheduled visits as PUBD check run by EDA cannot
discriminate by certain unscheduled or repeat visits, it is best to have all
unscheduled/repeats as blinded.

Data handling any additional handling of results should be

included in DTP/VSW
As is: original blinded file sent to recipient or placed in folder
Masked: Patient information masked so blinding is preserved but data
available for analysis

Requires programming for masking

New modality about 2 weeks for programming by EDI SAS group
Existing modality about 2 days for programming by EDI SAS group

Also requires header data loaded into database

For Internal Use Only. Amgen Confidential.

15

External Data

EDA to execute pubdchk for all header data prior to load into CTDB and non-ctdb
data files
Pubdchk output will need to be reviewed by EDA and FSP Ops lead to verify
PUBD
Do not load data if any PUB data found in header file
Do not place non-ctdb data files if any PUB data found in header file

Loading of PUBD data to CTDB only after signed unblinding form (i.e. FORM008236) is received and confirmation from LDM to load PUBD data. This is typically
within 3 days from Initial Lock

Any placement of PUBD data on ctshared:

Verify permissions of folder by manually reviewing the folder properties

If folder does not exist, request the Amgen FAST Business Owners (Mickey Cheng or Mehul Shukla) to
create the folder with appropriate restrictions.

For Internal Use Only. Amgen Confidential.

16

PUBD Checker: Purpose

Purpose: Check if there are any values in the any of the
blinded fields in header files received from external
vendor. Blinded Fields should be empty in header text
file
Frequency: Run PubD Checks when new Header file
arrives, initially when VSW is approved in addition
When to Run: Run the check before the Header Data
Load to DB
Programs:
/ctshared/cdm/sas/general/scripts/pubdcheck_macros.sas

For Internal Use Only. Amgen Confidential.

17

PUBD Checker: Requests

EDA Representative will request PubD check program
be set up for a study
The email includes: Study #, Vendor, Fields which are to
be blinded, Visits that should be blinded
Email also should have VSW attached

For Internal Use Only. Amgen Confidential.

18

PUBD Checker: Process

Navigate to the path: /cdm/product/study#/lab
Verify if pubdcheck directory exists. If not than create it.
E.g. /cdm/amg145/20090158/lab/pubdcheck

Check for program params.sas in the folder

If it does not exist, copy it from /ctshared/cdm/sas/general/scripts/
and modify it according to the requirements

Check for program for any particular lab in the folder

If it doesnt exist, (e.g. covance_a785_20062017.sas) copy from
/ctshared/cdm/sas/general/scripts/
Program Name: lab_axxx_xxxxxxxx and modify it according to the
needs of the current study. Name of the program should be
labname_aNNN_studynumber.sas, a sample code below

For Internal Use Only. Amgen Confidential.

19

PUBD Checker: Params.sas

Contents of this code:

1.Data Directory where the Vendor files are

located
2.Vendor Files
. Basically, defining macro variables that hold the values
of vendor data directory and the filenames e.g. below

For Internal Use Only. Amgen Confidential.

20

PUBD Checker: Set Up Caller program

If a new program is being set up, or existing program is
getting edited, the fields in red fonts must be updated

For Internal Use Only. Amgen Confidential.

21

PUBD Checker: Set Up Caller program

contd.

For Internal Use Only. Amgen Confidential.

22

PUBD Checker: Set Up Caller program

contd.
Datafilename: Chemlab_2 is taken for instance here.
Change to dataset being checked.
Setname: Must be assigned, usually 3-4 chars. It is a
user defined input field, e.g. cl2
Criteria 1 & Criteria 2: Used as message box to list fields
that are to be checked for blinding. If the list is long, use
Criteria2 to finish the list. If the list is small, leave
criteria2 null.

For Internal Use Only. Amgen Confidential.

23

PUBD Checker: Set Up Caller program

contd.
Data step that creates err dataset, use the setname
assigned in earlier step which is cl2. List all the fields
used in field list and criteria2, e.g. fieldname^=
The macro call %dump_err call should list datafilename
(e.g. Chemlab_2), Subjid Cpevent field_list

For Internal Use Only. Amgen Confidential.

24

PUBD Checker: QC Steps

Another SAS Programmer will be assigned to Validate the program
Validator navigates to the vendors folder under
/cdm/amgNNN/study_number/lab/vendor
E.g. /cdm/amg145/20110233/lab/covance

Validator creates a program named validation_initials, e.g.

validation_ms

For Internal Use Only. Amgen Confidential.

25

PUBD Checker: QC Steps Contd.

Validator copies files from lab data folder to validation folder that
was created in earlier step
Validator then in the validation folder renames the files inside, e.g.
the characters PROD or UAT will be replaced by PUBDVAL
E.g.
a916_20070561-PROD-COVANCEIN_DBL_UNIT-CHEMLAB_3FULL-2011AUG05124025.txt

would be changed to
a916_20070561-PUBDVAL-COVANCEIN_DBL_UNIT-CHEMLAB_3FULL-2011AUG05124025.txt

Changing the filename as mentioned will eliminate

any possibility of the file inadvertently being loaded

For Internal Use Only. Amgen Confidential.

26

PUBD Checker: QC steps contd.

Validator Opens files in validation folder either in Excel
or any text editor
Enters data into the fields that are expected to be
blinded
Refer to VSW for field attributes such as
character/numeric etc.
If some visits are to be blinded, data should be entered
in a row for at least one of those types of visits
Save and close the files and pubdchecker program

For Internal Use Only. Amgen Confidential.

27

PUBD Checker: QC Steps Contd.

On the UNIX prompt, enter command PUBDCHECK
System will prompt for study number and input file
location
For validation, input file location will be the validation
folder
PubDchecker program will display all unexpected data
on the UNIX window

For Internal Use Only. Amgen Confidential.

28

PUBD Checker: QC Steps Contd.

Validator Reviews this to make sure all the dummy data
entered in the test files show up on the UNIX screen
Also check for any other results found that validator did
not enter in the test file
If any unexpected results are found, the PubDchecker
program likely needs to be corrected and will get the
SAS Programmer to correct the issue
Once that done, Validation process returns to the
beginning of validation process and steps are repeated

For Internal Use Only. Amgen Confidential.

29

PubDChecker Program to PROD

If the pubdchecker program finds all expected results in
the test files, then the program is ready for PROD.
SAS Programmer will respond to the original request
email and inform the requestor that the program has
been validated and ready for PRODUCTION

For Internal Use Only. Amgen Confidential.

30

Scrambling: PubD and Header Data

Rave PubD Data
Header Data gets Loaded into RAVE
PubD data does not get loaded into RAVE until unblinding
of the study

Non-CTDB PubD Data

Header Data will be coming from external vendor
If the header data is in TXT(text) format, it should be
converted to SAS dataset(dataset name format:
ndb_xxx_1, where xxx denotes the type of data) and the
dataset should be stored in SSD folder of the study

For Internal Use Only. Amgen Confidential.

31

Scrambling: Making Requests

The request to scramble data comes from
CDM
GSP

If the PubD specs are not provided with the request, ask
for it.
PubD specs are created by Biostatistics/GSP. Ideally,
they should reside in EDM Teams

For Internal Use Only. Amgen Confidential.

32

Scrambling: Standard File Directories

Rave data
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd

Result Files
/cdm/amgXYZ/Protocol#/lab/bsm
/cdm/amgXYZ/Protocol#/lab/covance
/cdm/amgXYZ/Protocol#/lab/mrl

For Internal Use Only. Amgen Confidential.

33

Scrambling: Standard File Directories(Ctd.)

Non-CTDB Header Data

/
ctshared/amgXYZ/indication/Protocol#/cdm/sas/
edc/data/ssd
Non-CTDB Result Files

/cdm/amgXYZ/Protocol#/lab/bsm
/
ctshared/amgXYZ/indication/Protocol#/cdm/sas/
edc/data/ssd_blinded_qlab
For Internal Use Only. Amgen Confidential.

34

Scrambling: Libraries required for PubD

Extraction: /ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd
Disguised Assignment (Restricted)
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_da

PubD data (Restricted)

/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_blinded

Scrambled data
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_disguised

Ssd_da and ssd_blinded, both need to be restricted. Check with

FAST administrators (Mickey Cheng, Mehul Shukla)
If you do NOT have access to ssd_blinded and ssd_da, request
the access via FAST2

For Internal Use Only. Amgen Confidential.

35

Scrambling: Program Directory

Standard Macros Used are at:
/ctshared/cdm/sas/general/programs/macros

Macro Calling Programs at study level reside under:

/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/programs/dat
a_disguised

For Internal Use Only. Amgen Confidential.

36

Scrambling: Result Files (Rave)

Check if Path(s) to Result Files are provided
If not, request the path(s) to result files to CDM or Lab
Admin directly
Once we have this update the calling programs with the
new link and files as applicable
Note: AB and PK Result files must be in CRO format,
i.e. Tab Delimited. If theyre not provided in CRO format,
request it.
Note: Lab Result files are pipe | delimited

For Internal Use Only. Amgen Confidential.

37

Scrambling: Result Files (Non-CTDB)

Note: AB and PK Result TXT(text) files must be in
PROD format, i.e. pipe | delimited. If theyre not in
PROD format, request it.
The result data(which is in TXT format) should then be
converted to SAS dataset. Use the conversion
programs(if not already exists, create the conversion
program as per VSW) to do the conversion
Note: Lab Result file will be in SAS format(SAS dataset)

For Internal Use Only. Amgen Confidential.

38

Scrambling: Process
Rave
Extract Relevant RAVE data using CDMS2SAS
E.g. LAB, AB, PK etc.
This will extract the data under ../data/ssd
Check and confirm that ssd_blinded and ssd_da both are
restricted.

Non-CTDB

Header data(E.g. ndb_lab_1, ndb_ab_1, ndb_pk_1) will be

already available in SSD(../data/ssd) folder. If not, please
contact the study EDA

For Internal Use Only. Amgen Confidential.

39

Process (contd.)
If the program are not already set up, set it up. This can
be done by copying various programs from other study
and modifying it according to the needs
Programs reside under /programs/data_disguised at
study level

For Internal Use Only. Amgen Confidential.

40

Scrambling: Steps
Run MakeDA_Rave.sas macro to create disguised assignments.
This program needs to run the first every time there is a new
request for scrambling
It creates disguiseassignments.sas7bdat SAS Dataset under
ssd_da
Three variables: _pt_, Randomization Date, Disguised Assignments
Since this contains actual patient ids with corresponding disguised
assignments, one needs to be very careful with this. Accidental
leakage of the file can cause potentially unblinding

For Internal Use Only. Amgen Confidential.

41

Scrambling: Creating an Unblinding Data

(Rave scrambling)
This data is stored under:
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_blinded

Various Programs that create Unblinding data are:

o ReadBlindedAB_Rave.sas
o ReadBlindedPK_Rave.sas
o ReadSynarcBlinded.sas
o ReadBlindedLab.sas

What this does is Reads the Result Files, merges with Header data and
than creates the unblinded file with blinded data that is stored under
ssd_blinded which again is a restricted directory
Outputs from these are e.g. lab_u, ab_u, pk_u etc. Specs on naming the
files will be provided in the PubD specs

For Internal Use Only. Amgen Confidential.

42

Scrambling: Creating an Unblinding Data

(Non-CTDB scrambling)
This data is stored under:
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_blinde
d

Various Programs that create Unblinding data are:

o ReadBlind_NON_CTDB_Ab.sas
o ReadBlind_NON_CTDB_Pk.sas
o ReadBlind_NON_CTDB_Lab.sas

What this does is Reads the Result Files, merges with Header data
and then creates the unblinded file with blinded data that is stored
under ssd_blinded which again is a restricted directory
Outputs from these are e.g. db_ab_1_u, db_pk_1_u, db_lab_1_u etc.
Specs on naming the files will be provided in the PubD specs

For Internal Use Only. Amgen Confidential.

43

Scrambling: QC Step for Creating

Unblinding File
Open the relevant SAS Log
Check if there are any errors present. If there are any errors,
possibility is that in the macro calls, wrong filenames or pathnames
are given. There may be some other reasons that need to be
investigated if errors are due to some other reasons
Check for ALERT message. ALERTS are present in case of there is
any mismatch of the data, i.e. record exists in result files, but
corresponding record does not exist in header file. E.g.
ALERT: Data from results file does not have a matching header record
in LAB_ALL: _pt_=10966419001 Folder=W48 SASNAME=APO_B
ALERT: Data from results file does not have a matching header record
in LAB_ALL: _pt_=10966419001 Folder=W48 SASNAME=LDL_DR

For Internal Use Only. Amgen Confidential.

44

Scrambling: To Resolve Mis-Matches of

Data
Contact EDA or BSM as applicable, provide these alerts
and request to check and get the updated header file.
Stop processing the file that has ALERTS.
For Labs, only provide the alert as in example above. Do
NOT provide VISIT Date, VISIT Date Raw or Visit Time.
These are actually present in SAS Log, but when
providing the ALERT to these fields need to be taken
out.

For Internal Use Only. Amgen Confidential.

45

Scrambling: Create Scrambled Data

(Rave Scrambling)
Scrambled data resides under:
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_disguised

Programs that create Scrambled data are:

o MakeDisguisedDataAB_Rave.sas
o MakeDisguisedDataPK_Rave.sas
o MakeDisguisedLabData_Rave.sas
Basically, each of these program to create scrambled data call the macro
MakeDisguisedData_Rave.sas
Calling program to create scrambled data may not be a separate calling
program, in other words, it maybe incorporated within the ReadBlindXYZ.sas
program that creates the unblinded files. To avoid confusion, it would be
better to keep it separate call.
E.g. lab_d, ab_d, pk_d

For Internal Use Only. Amgen Confidential.

46

Scrambling: Create Scrambled Data

(Non-CTDB Scrambling)
Scrambled data resides under:
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_disg
uised

Programs that create Scrambled data are:

o MakeDisguised_NONCTDB_Ab.sas
o MakeDisguised_NONCTDB_Pk.sas
o MakeDisguised_NONCTDB_Lab.sas
Outputs from these are E.g. db_ab_1_d,
db_pk_1_d, db_lab_1_d

For Internal Use Only. Amgen Confidential.

47

Scrambling: QC Steps on Scrambled

Data
Number of Records in _u and _d should match.
Check _d data against PubD specs. All variables per specs must be present.
Check if there is any restriction on number of unique subjects in disguise data
mentioned in the SPEC. If yes, the links should be released only if the subject
count in SPEC matches with the subject count in disguised dataset. Otherwise
it will lead to unblinding scenario.
Make sure the result values in result files/datasets are available in the
scrambled datasets(in some cases the results may be missing due to
programming issues)
Any exclusions in specs should also reflect in the dataset. E.g. For some
studies, SCR visit may already be unblinded. So, the scrambled data and
unblinded data should not have visit for SCR. Similar is true for any analyte as
well.
Make sure that naming convention is followed.

For Internal Use Only. Amgen Confidential.

48

Scrambling: Header Data

Any data that is NOT PubD is considered to be Header
Data
Entered into Rave for Rave studies
For Non-CTDB, the header data will be provided by the
external vendor
At the end of the scrambling process, copy header data
e.g. Lab_All,ndb_lab_1(for Non-CTDB) from ssd to
ssd_header.

For Internal Use Only. Amgen Confidential.

49

Scrambling: Outputs in Nutshell

At the end of the process the following outputs are expected
(just using labs for example):
LAB_U or db_lab_1_u(for Non-CTDB) : PubD Data stored in
ssd_blinded
LAB_D or db_lab_1_d(for Non-CTDB) : Scrambled Data
stored under ssd_disguised
Then from ssd directory, LAB_ALL or ndb_lab_1(for NonCTDB) copied over to ssd_header
/
ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd
_header

For Internal Use Only. Amgen Confidential.

50

Scrambling: Common Issues

Failure to check SAS Logs of the relevant programs

Using wrong Files

Use Copy and Paste, but forget to update the code per specs

For labs in CTDB, missing calculated SI values in the scrambled output

In order to calculate the SI values, the analyte unit and conversion factor (from reported unit to SI unit) must
be set up in Rave Lab Admin module for the analyte. In addition, the range (specifically the high range) must
be assigned to the analyte for the lab vendor used for the study.

Remediation:

If conversion factor is missing, LDM to confirm with LDR if there is an available conversion factor. If so,
the conversion factor is to be approved and added to the analyte in the Rave Lab Admin Module. If no
conversion factor is available, SI value cannot be provided in the scrambled dataset only reported
values

If only the range is missing, LDM to confirm with LDR if textbook ranges are available for use in the
study. If available, LDM to request to update ranges for the study. If not available, LDM to request dummy
ranges to be used (i.e. 0-999). Note, the dummy range selected should be such that none of the results
are falsely flagged as abnormally low or high.

For Internal Use Only. Amgen Confidential.

51

Scrambling: Final Steps

Create a dated folder, e.g. October_2012 under each ssd_blinded, ssd_disguised

and ssd_header, depending on when the data is requested

Move all unblinded/PubD data from ssd_blinded directory to the Month_year folder
created under it.
E.g. Move _u files from /ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_blinded
to /ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_blinded/Month_Year

Move all Scrambled Data from ssd_disguised to the Month_year folder created under
it.
E.g. Move _d files from /ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_disguised
to /ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/data/ssd_disguised/Month_Year

NOTE: The SLA to process PubD is 3 Business Days. In case of New studies that need this set up, it may
take a day or two additional.

For Internal Use Only. Amgen Confidential.

52

Scrambling: Copy Header Data

Header Data under ssd directory to be COPIED over
from ssd to ssd_header/Month_Year
E.g.
COPY _all files(related to the data being scrambled)
from
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/da
ta/ssd
to
/ctshared/amgXYZ/indication/Protocol#/cdm/sas/edc/da
ta/ssd_header/Month_Year

For Internal Use Only. Amgen Confidential.

53

Scrambling: Sending Links to the

Requestor
The email having the request to scramble data may
have information on who to send the links of the
processed data. If it does not have that information,
request it.
DO NOT send the data as an attachment to the email.
ALWAYS send the LINKS only

For Internal Use Only. Amgen Confidential.

54

Scrambling: Sending Links 2.

Once the data has been processed and all steps QCed,
send the data manager and blinded GSP programmer
links of Header and Scrambled Data
E.g.
\\Filesrv10\CTSHARED\amg145\hce\20110109\cdm\sas\
edc\data\ssd_header\October_2012
\\Filesrv10\CTSHARED\amg145\hce\20110109\cdm\sas\e
dc\data\ssd_disguised\October_2012

For Internal Use Only. Amgen Confidential.

55

Scrambling: Sending Links 3

Send the links of PubD and Header Data to Unblinded
Programmer. E.g.
\\Filesrv10\CTSHARED\amg145\hce\20110109\cdm\sas\
edc\data\ssd_header\October_2012
\\Filesrv10\CTSHARED\amg145\hce\20110109\cdm\sas\e
dc\data\ssd_blinded\October_2012

For Internal Use Only. Amgen Confidential.

56

Scrambling: Sample PubD specs

For Internal Use Only. Amgen Confidential.

57