thinking outside the box: sdtm mapping in real lifeportal.cdisc.org/cdisc user...
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CONFIDENTIAL © 2017 PAREXEL INTERNATIONAL CORP.
THINKING
OUTSIDE THE
BOX:
SDTM MAPPING
IN REAL LIFE14Feb2017 24th German User Group Meeting Eschborn / Clinipace
Petra Rein
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AGENDA:
MAPPING IN REAL
LIFE
OR
HOW TO DEAL WITH
NON FITTING CRFs
• Thinking outside the box I
• How To
• Examples
–FA, SUPPLEMENTAL or other option?
–Rescreening
–Investigator information
• Thinking outside the box II
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BERLIN, GERMANY
THINKING OUTSIDE
THE BOX I
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THINKING OUTSIDE THE BOX I
Most Case Report Forms (CRFs) contain information that do not fit easily
or at all into the standards from CDISC.
• CDISC
• SDTMIG and SDTM
• Insert all information from CRF
• Do not violate the rules(FDA, CDISC)
• Everything allowed whenwithin scope of implementation guide
• A box
• Draw max. 4 straight lines
• Catch all 9 dots
• Do not lift the pen and do not use the same line twice or more
• There might be morethan one solution
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DUBLIN, IRELAND
HOW TO GET STARTED
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A THREE-STAGE PLAN TO GET STARTED:
1.1.
2.2.
3.3.
Who needs the information (statistican, the FDA, sponsor, …)? Should it be stored, can it be dropped?
What is the purpose of the information? • background information • additional (useful) relationship• (better) organization / structuring of data• details for historical data
Where to store the information best in main domain as --CAT, --SCAT, several --ID´s or other possible variables per SDTM? • in Supplemental Domain • in Findings About • in Custom Domain
.
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TAIPEI, TAIWAN
EXAMPLES:
REAL LIFE MAPPING
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EXAMPLE 1: FA, SUPPLEMENTAL OR OTHER OPTIONS?
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EXAMPLE 1: FA, SUPPLEMENTAL OR OTHER OPTIONS?
(CONT. I)
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EXAMPLE 1: FA, SUPPLEMENTAL OR OTHER OPTIONS?
(CONT. II)
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EXAMPLE 2: RESCREENING
Requirements
• Subject may be re-screened three times before excluded / included in the study.
• New patient number for a new re-screening.
• All information should be kept with one patient number in the end.
Challenges
• Keep consistent patient number for all related information.
• Keep „unplanned/planned“ re-screening visits.
• Do not violate FDA/CDISC rules.
Solutions
• Several models of mapping are possible.
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EXAMPLE 2: RESCREENING (CONT. I)
DM
SUPPDM
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EXAMPLE 2: RESCREENING (CONT. II)
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EXAMPLE 2: RESCREENING (CONT. III)
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EXAMPLE 3: INVESTIGATOR INFORMATION
Who?
• CDER / FDA may ask for a „Summary Level Clinical Site Data” dataset, which contains
information related to investigators at site.
• http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionReq
uirements/ucm332466.pdf (most recent version)
• http://www.fda.gov/downloads/drugs/developmentapprovalprocess/formssubmissionrequire
ments/ucm332468.pdf (draft guidance)
What?
• Purpose of this is verifying the integrity of data, checking compliance to applicable FDA
regulations and statutory requirements, ensuring rights / welfare of patients => to avoid
fraud due to inspections on sites and related study data.
Where?
• As some information is kept in DM it would be logical to keep it in SUPPDM.
• A custom domain can be created if needed.
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EXAMPLE 3: INVESTIGATOR INFORMATION (CONT. I)
Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning (07.Nov.2012, v1.2, p.7)
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EXAMPLE 3: INVESTIGATOR INFORMATION (CONT. II)
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EXAMPLE 3: INVESTIGATOR INFORMATION (CONT. III)
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EXAMPLE 3: INVESTIGATOR INFORMATION (CONT. IV)
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EXAMPLE 3: INVESTIGATOR INFORMATION (CONT. V)
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LONDON, U.K.
THINKING
OUTSIDE THE BOX II
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THINKING OUTSIDE THE BOX II
Red triangles are similar to non-standard data presented in the SDTMIGand SDTM from CDISC.
As long as the rules in the box are kept everything outside is possible.
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THANK YOU
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