Describing Data from Capture to Operational Use to CDISC Compliant Submission O. Kitamura, D. Madrid, Y. Oldshue, L. Spencer Takeda Global Research & Development, One Takeda Parkway, Deerfield, IL, USA 60015 Pure SDTM T-SDTM EDC 8 4 6 10 11 An Efficient, Cost Effective Approach to Development of a CDISC Package • Takeda’s past CDISC-compliant submissions using mapping of legacy data have proven: – Costly – Labor intensive – Time consuming • CDSIC compliance is difficult to achieve at the end of the data management and analysis process • Creating an interim Takeda SDTM (T-SDTM) database – Maximizes operational efficiencies – Minimizes submission creation resources and costs 1 Three Past Strategies for Submissions in CDISC Format Remap to CDISC standards before submission No change to C RFs, data, analysis processes, standards, tools -Large additional resources: - Converting data - Repeating an al yses - Tw o versi ons of specs Two parallel databases during study - No changes to CRFs, data co llec tion - No s ignifi cant changes for sub mi ssi on - Same data for analysis and sub mi ssi on - Changes to analysis tools - Duplication, higher cost CDISC Standards (almost) from CRFs to submission -No significant changes for submission - S ame dat a for a na lysis and submission - Changes to Ta keda CRF s, controlled terminology - Problems creating , lock ing “raw” database 2 CDISC-Based Standards System • CDISC compliant FDA submissions will become an official requirement • CDISC-related standards are already the industry practice • This CDISC-Based standards system includes: – All core CDISC requirements – The operational efficiencies of the legacy system – With the final transformation to “pure” CDISC standards handled at submission • The CDISC-Based system begins at study start: – Changes to protocols facilitate CDISC compliance – CDASH conformance and SDTM compliance – Takeda SDTM (T-SDTM) database is a bridge between EDC and SDTM data 3 Global Operational Master Specification (GOMS) • Single Excel spreadsheet to facilitate management of all data from collection to submission • Includes specifications for: – EDC – T-SDTM – SDTM • Includes mapping logic for each transformation step 5 CDISC Compliance • All data stores adhere to CDISC standards as closely as possible – Extensions to EDC or T-SDTM variable names allow unique but compliant names • Single document maintains traceability from EDC to SDTM • EDC variable naming conventions indicate mapping to T- SDTM – Useful when EDC variables in one form are divided into more than one T-SDTM dataset – Simplifies programming • T-SDTM to SDTM mapping managed within GOMS • ADaM mapping is described in a separate document 7 9 The Benefits of T-SDTM • Allows integration of non-EDC data before final SDTM creation • Retains operational EDC variables to facilitate data cleaning and review • Preserves SAS formats for ease of programming • Maintains dates and times in programmable and analyzable formats • Transposes horizontal EDC structures to vertical SDTM model • Retains data organization of CRF to facilitate data review by non-technical team members 12
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Describing Data from Capture to Operational Use to CDISC Compliant Submission
O. Kitamura, D. Madrid, Y. Oldshue, L. SpencerTakeda Global Research & Development,
One Takeda Parkway, Deerfield, IL, USA 60015
Pure SDTM T-SDTM
EDC
84
6 10
11
An Efficient, Cost Effective Approach to Development of a CDISC Package
• Takeda’s past CDISC-compliant submissions using mapping of legacy data have proven:
– Costly
– Labor intensive
– Time consuming
• CDSIC compliance is difficult to achieve at the end of the data management and analysis process
• Creating an interim Takeda SDTM (T-SDTM) database
– Maximizes operational efficiencies
– Minimizes submission creation resources and costs
1
Three Past Strategies for Submissions in CDISC Format
Remap to CDISC standards before
submission
No change to CRFs, data, analysis processes, standards, tools
- Large addit ional resources:- Converting data
- Repeating an alyses
- Tw o versions of specs
Two parallel databases during
study
- No changes to CRFs, data co llection
- No s ignificant changes for sub mission
- Same data for analysis and sub mission
- Changes to analysis tools
- Duplication, higher cost
CDISC Standards (almost) from CRFs
to submission
- No significant changes for submission
- Same data for analysis and submission
- Changes to Takeda CRFs, controlled terminology- Problems creating, lock ing “raw” database
2
CDISC-Based Standards System• CDISC compliant FDA submissions will become an official
requirement
• CDISC-related standards are already the industry practice
• This CDISC-Based standards system includes:– All core CDISC requirements
– The operational efficiencies of the legacy system
– With the final transformation to “pure” CDISC standards handled at submission
• The CDISC-Based system begins at study start:– Changes to protocols facilitate CDISC compliance
– CDASH conformance and SDTM compliance
– Takeda SDTM (T-SDTM) database is a bridge between EDC and SDTM data
3
Global Operational Master Specification (GOMS)
• Single Excel spreadsheet to facilitate management of all data from collection to submission
• Includes specifications for:
– EDC
– T-SDTM
– SDTM
• Includes mapping logic for each transformation step
5
CDISC Compliance• All data stores adhere to CDISC standards as closely as
possible– Extensions to EDC or T-SDTM variable names allow unique but
compliant names• Single document maintains traceability from EDC to
SDTM• EDC variable naming conventions indicate mapping to T-
SDTM– Useful when EDC variables in one form are divided into more
than one T-SDTM dataset
– Simplifies programming• T-SDTM to SDTM mapping managed within GOMS• ADaM mapping is described in a separate document
7
9
The Benefits of T-SDTM• Allows integration of non-EDC data before final SDTM
creation• Retains operational EDC variables to facilitate data
cleaning and review
• Preserves SAS formats for ease of programming• Maintains dates and times in programmable and
analyzable formats
• Transposes horizontal EDC structures to vertical SDTM model
• Retains data organization of CRF to facilitate data review by non-technical team members
12
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