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© CDISC 2014 CDISC Members Only Webinar- Ensuring USUBJID is Unique for an Individual in an Application 12 Feb 2015 1
© CDISC 2014
CDISC Members Only Webinar-
Ensuring USUBJID is Unique for an
Individual in an Application
12 Feb 2015
1
© CDISC 2014
Agenda• Ensuring USUBJID is Unique for an Individual in an
Application
Monica Mattson, Celgene
Mark Sullivan, PAREXEL
Gary Walker, Quintiles
• Guest Q&A Panelists
Wayne Kubick, CDISC
Fred Wood, Accenture
• CDISC Education and Events Updates*
John Ezzell, CDISC
*After Q&A session & time permitting
2
© CDISC 2014
Question & Answer
• ‘Presenter’: Question
Example:
Monica: When will Batch 21 be published?
3
Ensuring USUBJID is Unique for
an Individual in an Application
Presented by
Monica Mattson, Celgene Corporation
Mark Sullivan, PAREXEL International
Gary Walker, Quintiles
Disclaimer
The opinions expressed in this webinar are
those of the presenters and do not
necessarily represent the opinions of CDISC,
PhUSE, members’ respective companies or
organizations, or regulatory authorities. The
content in this webinar should not be
interpreted as a data standard nor as
information required by regulatory authorities.
PhUSE
• Pharmaceutical Users Software Exchange
• Provides global platform for topics
concerning DM, biostatistics, Statistical
Programmers, and eClinical IT
• www.phuse.eu
• PhUSE Computational Science
Symposium held annually in March
USUBJID Working Group
• Formed March 2014 to address issues
with implementation of USUBJID
• Broad member representation
• Regular meetings throughout 2014
• Objective: develop a recommendation for
ensuring a unique USUBJID for each
individual, both within and across studies
in an application
Unique Identifier per 1999
Guidance• Section 4.k.6
– “Each subject should be
identified with a single,
unique number for the
entire application. The
unique number needs to be
provided in each dataset.
This is essential for joining
different datasets.”
USUBJID per SDTM IG v3.2
• Section 4.1.2.3– “To identify a subject uniquely across all studies for all
applications or submissions involving the product, a
unique identifier (USUBJID) should be assigned and
included in all datasets… USUBJID values must be unique
for each trial participant (subject) across all trials in the
submission. This means that no two (or more) subjects,
across all trials in the submission, may have the same
USUBJID. Additionally, the same person who participates
in multiple clinical trials (when this is known) must be
assigned the same USUBJID value in all trials.”
USUBJID per Dec 2014
Technical Conformance Guide• Section 4.1.1.2
– “Each individual subject should be assigned a single
unique identifier across the entire application… An
individual subject should have the exact same unique
identifier across all datasets, including between SDTM and
ADaM datasets. Subjects that participate in more than one
study should maintain the same USUBJID across all
studies…Improper implementation of the USUBJID
variable is a common error with applications and often
requires sponsors to re-submit their data.”
Problem Statement
• Sponsors are required to ensure a
consistent single USUBJID value is
assigned to each individual with data in
the application
Considerations
• “Subject” frequently used to define two
different concepts
– Individual person
– Participant in
clinical trial
Considerations
• USUBJID vis-à-vis SUBJID
– History: 1:1 relationship
– Reality: 1:1 or 1:many
• Record structure for SDTM DM domain is
“One record per subject”
– “Subject” not overtly defined as trial participant, nor as unique individual
• SUBJID – topic variable for SDTM DM
Considerations
• Dec 2014 Technical Conformance Guide
– Section 4.1.1.2 on SUBJID: “If the same subject is screened more than once in a trial, then the subject’s SUBJID should be different.”
• Rationale for Recommendations
– PhUSE WG recommendations predicated on the concept that “one record per subject” is defined as “one record per SUBJID”
• Not a CDISC standard
USUBJID – Recommendations for:
• Data Collection
• Assigning USUBJID for Multiple Enrollments (once/study)
Challenge: Data Collection
• Identifying USUBJID
– Individuals enrolled
in more than
one study
Application
Study1 Study2 Study3
Challenge: Data Collection
• Identifying USUBJID (cont)
– Individuals enrolled
more than once
in the same study
Screen Fail Enrolled Subject
Same individual with unique SUBJID
Recommendation 1:
Data Collection• Design database to track previous
enrollments
– Typically via CRF
– Recommended fields
• If previously enrolled in current study, SITEID and
SUBJID of previous enrollment (assumes
sponsor is tracking screen fail data)
• If previously enrolled in other study, STUDYID,
SITEID, and SUBJID from the other study/ies
Considerations: Data Collection
• Need to allow for both multiple previous enrollments within the same study (re-screens) and enrollments from multiple previous studies
• Data fields must be sufficient to identify whether individual has existing USUBJID
Data Collection: Sample CRF
USUBJID with Multiple
Enrollments (once/study)
• Easiest scenario: Assigning USUBJID
when individual has enrolled in multiple
studies in an application, maximum
once/study
– Reflects how SDTM was developed
• Use information gathered per prior data
collection recommendation
USUBJID with Multiple
Enrollments (once/study)
This does not reflect any guidance for creation for the USUBJID
USUBJID – Recommendations for:
• Assigning USUBJID with Multiple Enrollments (>1x/study)
• Managing SUBJID
Challenge: USUBJID with
Multiple Enrollments (>1x/study)
• What to do when these multiple subjects
are the same person?
– What if our study allows people who fail screening to try to enroll in the study later?
DM
… SUBJID … RFICDTC RFPENDTC … ARMCD …
… 3-001 … 2010-06-18 2010-06-23 … SCRNFAIL …
… 3-101 … 2010-07-21 2010-07-26 … SCRNFAIL …
… 3-201 … 2011-01-17 2011-08-15 … ARM-A …
Issues Found during Initial
Investigation by PhUSE WG
• One record per USUBJID in DM approach
– Key structure: STUDYID, USUBJID
DM
… USUBJID SUBJID … RFICDTC … ARMCD …
… STDY1-3-201 3-201 … 2011-01-17 … ARM-A …
SUPPDM data
SUBJID1 SUBJID2
3-001 3-101
SUPPDM
… USUBJID … QNAM QLABEL QVAL …
… STDY1-3-201 … SUBJID1 Subject Identifier 1 for the study 3-001 …
… STDY1-3-201 … SUBJID2 Subject Identifier 2 for the study 3-101 …
Issues Found during Initial
Investigation by PhUSE WG• Record timing information in SUPPDM for
different enrollmentsDM
… USUBJID SUBJID … RFICDTC RFENDTC … ARMCD …
… STDY1-3-201 3-201 … 2011-01-17 2011-08-15 … ARM-A …
SUPPDM
… USUBJID … QNAM QLABEL QVAL …
… STDY1-3-201 … SUBJID1 Subject Identifier for the study 1 3-001 …
… STDY1-3-201 … RFICDTC1 Date/Time of Informed Consent 1 2010-06-18 …
… STDY1-3-201 … RFPEDTC1 Date/Time of End of Participation 1 2010-06-23 …
… STDY1-3-201 … ARMCD1 Planned Arm Code 1 SCRNFAIL …
… … … … … … …
… STDY1-3-201 … SUBJID2 Subject Identifier for the study 2 3-101 …
… STDY1-3-201 … RFICDTC2 Date/Time of Informed Consent 2 2010-07-21 …
… STDY1-3-201 … RFPEDTC2 Date/Time of End of Participation 2 2010-07-26 …
… STDY1-3-201 … ARMCD2 Planned Arm Code 2 SCRNFAIL …
… … … … … … …
Issues Found during Initial
Investigation by PhUSE WG• Review blood pressure associated with
screening events: joined datasetsDM
SUBJID RFICDTC ARMCD
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
Join variable VS
USUBJID VSSEQ VSTESTCD VSDTC
STDY1-3-201 1 SYSBP 2010-06-18
STDY1-3-201 2 DIABP 2010-06-18
STDY1-3-201 20 SYSBP 2010-07-21
STDY1-3-201 21 DIABP 2010-07-21
STDY1-3-201 50 SYSBP 2011-01-17
STDY1-3-201 51 DIABP 2011-01-17
Issues Found during Initial
Investigation by PhUSE WG• Review blood pressure associated with
screening events: joined datasetsDM
SUBJID RFICDTC ARMCD
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
3-201 2011-01-17 ARM-A
Join variable VS
USUBJID VSSEQ VSTESTCD VSDTC
STDY1-3-201 1 SYSBP 2010-06-18
STDY1-3-201 2 DIABP 2010-06-18
STDY1-3-201 20 SYSBP 2010-07-21
STDY1-3-201 21 DIABP 2010-07-21
STDY1-3-201 50 SYSBP 2011-01-17
STDY1-3-201 51 DIABP 2011-01-17
SUPPDM data
SUBJID1 SUBJID2 RFICDTC1 RFICDTC2
3-001 3-101 2010-06-18 2010-07-21
3-001 3-101 2010-06-18 2010-07-21
3-001 3-101 2010-06-18 2010-07-21
3-001 3-101 2010-06-18 2010-07-21
3-001 3-101 2010-06-18 2010-07-21
3-001 3-101 2010-06-18 2010-07-21
Recommendation 2: USUBJID
with Multiple Enrollments• Create a new record in DM for each screening attempt
– Does not adhere to common practice
– PhUSE WG interpretation of “one record per subject” =
“one record per SUBJID”
– Resulting DM domain easy to interpret
– Key structure: STUDYID, USUBJID, SUBJID
DM
… USUBJID SUBJID … RFICDTC RFPENDTC … ARMCD …
… STDY1-3-201 3-001 … 2010-06-18 2010-06-23 … SCRNFAIL …
… STDY1-3-201 3-101 … 2010-07-21 2010-07-26 … SCRNFAIL …
… STDY1-3-201 3-201 … 2011-01-17 2011-08-15 … ARM-A …
Considerations: USUBJID with
Multiple Enrollments• Assumes different SUBJID assigned per
screening event
– Expectation per Dec 2014 Technical Conformance Guide
– Allows unique record qualifiers for each enrollment
DM
… USUBJID SUBJID … RFICDTC RFPENDTC … ARMCD …
… STDY1-3-201 3-001 … 2010-06-18 2010-06-23 … SCRNFAIL …
… STDY1-3-201 3-101 … 2010-07-21 2010-07-26 … SCRNFAIL …
… STDY1-3-201 3-201 … 2011-01-17 2011-08-15 … ARM-A …
Recommendation 3: SUBJID as
Available Identifier on GOC Domains
• Allows link of assessments back to specific
screening event
• Requires SUBJID unique to each screening event
VS
USUBJID SUBJID VSSEQ VSTESTCD VSDTC
STDY1-3-201 3-001 1 SYSBP 2010-06-18
STDY1-3-201 3-001 2 DIABP 2010-06-18
STDY1-3-201 3-101 20 SYSBP 2010-07-21
STDY1-3-201 3-101 21 DIABP 2010-07-21
STDY1-3-201 3-201 50 SYSBP 2011-01-17
STDY1-3-201 3-201 51 DIABP 2011-01-17
DM
… USUBJID SUBJID … RFICDTC RFPENDTC … ARMCD …
… STDY1-3-001 3-001 … 2010-06-18 2010-06-23 … SCRNFAIL …
… STDY1-3-001 3-001 … 2010-06-18 2010-06-23 … SCRNFAIL …
… STDY1-3-001 3-101 … 2010-07-21 2010-07-26 … SCRNFAIL …
… STDY1-3-001 3-101 … 2010-07-21 2010-07-26 … SCRNFAIL …
… STDY1-3-001 3-201 … 2011-01-17 2011-08-15 … ARM-A …
… STDY1-3-001 3-201 … 2011-01-17 2011-08-15 … ARM-A …
Impact of Recommendations 2 / 3
• Would require change to SDTM
– SUBJID in Table 2.2.4 as an available identifier
variable
• Would require change to SDTM-IG
– Impact analysis would be needed for full
assessment, but minimally a Section 4
assumption(s) allowing SUBJID to be added as
an available identifier variable
• Impact on other CDISC models
– Out of scope for PhUSE Working Group
Summary of PhUSE WG
Recommendations
• Plan proactively on how to collect data to
populate USUBJID
• Enter a separate record in DM domain for
each screening event
– Different from historical implementation of DM domain
• Add SUBJID as permissible identifier
variable in GOC domains
Questions?
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