vertex and cdisc / mbc / 12march2008 1. vertex and cdisc accomplishments and strategy 12 march 2008...
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Vertex and CDISC / MBC / 12March2008 .
1
Vertex and CDISC Accomplishments and Strategy
12 March 2008
Lynn AndersonAssociate Director
Statistical Programming/BiometricsPam Ryley, Associate DirectorScott Moseley, Senior Director
Vertex and CDISC / MBC / 12March2008 .
2
Vertex and CDISC - Overview
SDTM, ADAM (and CDASH)
• Operations and Submissions
• In-House and Out-Source
• Business Processes and Quality Architecture
• Technology and Tools
Vertex and CDISC / MBC / 12March2008 .
3
Vertex and CDISC - Overview
• CDASH – Clinical Data Acquisition Standards - FUTURE
• SDTM – Study Data Tabulation Model
• ADAM – Analysis Dataset Model
Vertex and CDISC / MBC / 12March2008 .
4
Vertex- CDISC – 2008 Goals - 50,000 ft
Raw Data(If possible, close to SDTM/CDASH)
SDTMIncludes trial design
and define.xml
ADAM
Operations
SDTM ADAM
SDTM & ADAM TFLs
SDTM loaded into WebSDM
Submissions
SDTM
Annotated eCRF
Define.xml
ADAM
ADAM and Key Tables Programs
Vertex and CDISC / MBC / 12March2008 .
5
CDASH - 5,000 ft
1. Take CDASH into account when building clinical database
• Extracted ‘raw’ data is standardized for ‘easy’ transformation into the SDTM model
• Enabled by standardized eCRFs
• Applies to external data sources also (either integrated into the clinical database or not)
Vertex and CDISC / MBC / 12March2008 .
6
SDTM and ADAM - 5,000 ft
SDTM datasets
• Specification – automation drives datasets development, review, and submission metadata
• Development – (In-House) SDLC – automation
• Review – WebSDM plus outside WebSDM
• Use for data review
• Use for developing ADAM datasets
• Use for analysis (with ADAM datasets)
• Submit to regulatory agency
Vertex and CDISC / MBC / 12March2008 .
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SDTM and ADAM - 5,000 ft
CDASH eCRF
SDTM Study Data
Clinical Database
CDASH StudyData
Build DB Extract Raw Data
Transform ToSDTM
ADAMStudy Data
Analysis (TFL’s)
Submit:
•Annotated eCRFs•SDTM Datasets•ADAM Datasets•TFL’s•Metadata (define)
Vertex and CDISC / MBC / 12March2008 .
8SDTM Datasets Specification– 500 ft
CDISC Master Domains Metadata Template (Enhanced with Vertex domains, columns, suppqual
standards, and mapping logic)Plus
CDISC Controlled Terminology Template Are Customized and Then Drive
• Specification of Conversion of Raw data into SDTM format
• Development of SDTM Datasets from Raw Data
• Review of SDTM Datasets for correctness against the standard and against the raw data
• Submission Metadata
Vertex and CDISC / MBC / 12March2008 .
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SDTM Datasets Specification– 500 ft
CDISC_spec SAS Macro
Part 1 General SDTM
Specification
Part 2 Study
Specific SDTM
Specification
CDISC Master
Domains Workbook
PLUS
CDISC Master
Terminology Workbook
PLUS
WriteSpec.SAS
Part 3 Detailed SDTM
Specification
Vertex CDISC SDTM
Specification
Put pieces together into one document
Vertex and CDISC / MBC / 12March2008 .
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SDTM Datasets Development – 500 ft
• Independent QC is incorporated into development whether in-house or outsource
• At Vertex this is an automation in progress – mapping and logic columns in the specification driver workbook also drive macro programming to create these datasets
Vertex and CDISC / MBC / 12March2008 .
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Review of SDTM Datasets – 500 ft
• Review plan talks about strategy for review – this will differ between when we are outsourcing (more extensive) versus when we are developing datasets in-house (since tools in this case are validated and trusted by us)
• Use of WebSDM in this process gives added benefit of providing a single repository for our clinical trials data – AND gives an opportunity to conduct WebSDM-style safety review on single and pooled studies
Vertex and CDISC / MBC / 12March2008 .
12Review of SDTM Datasets With WebSDM
Data ReviewYesDatasets
Readyfor Review?
Augment Checks in
Accordance with Review
Plan
Create StudyCreate
Application
Review SDTM Errors
Load datasets
Assign Error Details to SDTM
Errors
Copy Datasets to Load Area
Create Directories in
Load Area
Receive Datasets
Yes
Preprocess Datasets
Feedback to SDTM
Dataset Developers
No
Download SDTM Errors
Successful Load?
Specify CDISC SDTM Datasets
Develop CDISC SDTM Datasets
Develop Review Plan for CDISC SDTM Datasets
21
No
3
4 5 6 7 8 9 10 11
14 16 1712 1513
18Accept
Datasets?
No
Yes
Assign Error Details to
SDTM Errors
19
Accept Datasets
20 21
Vertex and CDISC / MBC / 12March2008 .
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Create ADAM datasets from SDTM
5. Develop ADAM datasets from SDTM datasets (and Protocol/SAP of course)
6. Develop TFL’s from SDTM and ADAM (Programming specifications)
7. Submission: SDTMs, SDTM annotated CRF, define.xml, ADAMs, TFLs, Key Programs for ADAMs and Tables
Vertex and CDISC / MBC / 12March2008 .
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Out-Source versus In-House
We want a single set of logical and consistent processes (supported by thorough repetitive training) but where does outsource versus in-house present a challenge?
• Anything about CDASH • Development of SDTM Datasets• Review of SDTM Datasets• Other
Vertex and CDISC / MBC / 12March2008 .
15SOP and Working Instruction Framework
• We are committed to develop & maintain a quality and business process framework that makes sense.
• While CDISC adoption is a unique effort from TFL’s production and FDR support and FDA submissions, we need these activities to all reference the same Systems Development Lifecycle
• Inversely, we need our Vertex Statistical Programming Systems Development Lifecycle to support all our departmental responsibilities
Vertex and CDISC / MBC / 12March2008 .
16SOP and Working Instruction Framework
Definition of DepartmentsBiometrics = Biostats and Stat Programming
Quality
Software/System Development Life Cycle (SDLC)
TFLsSAPS
Interims
Blinding
CDASH
SDTMs
ADAMsSubmissions
WI’s
Specification of SDTM
SDTM Review
WebSDM App & Study Config
Macro Library Dev
WebSDM App & Study Config
Vertex and CDISC / MBC / 12March2008 .
17Future Directions
• Standardize processes more: revisit, improve
• Automate processes more: specification, raw data transformation to SDTM, more data review tools based on SDTM, create ADAMs, create metadata (define)
• Integrate processes and tools across the larger process more tightly
• Timings: create SDTM (including Trial Design) and define.xml earlier
Vertex and CDISC / MBC / 12March2008 .
18Future Directions
• Extend training and distribute the CDISC understanding and tasks
• Continue improving quality framework – processes that are supported sufficiently by official documentation and that are clear and work across outsource scenarios
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