Transcript WG4: Data Guide/Data Description

WG4: Data Guide/Data Description
Work Group Meeting
August 29, 2012
Agenda
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Introductions
Recap of Data Guide project plan
Purpose and scope for this work group
Summary of activities to date
Initial review of proposed data description content
Next steps
Data Guide Sub-team
Sub-team Co-leads:
– Scott Bahlavooni, Genentech
– Joanna Koft, Biogen Idec
– Gail Stoner, J&J (also CDISC liaison)
– Helena Sviglin, CDER FDA
– Douglas Warfield, CDER FDA
– Amy Malla, CBER FDA
Data Description Work Group
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Gail Stoner – Lead
Scott Bahlavooni
John Brega
Nancy Brucken
John Franchino
Susan Kenny
Steve Kirby
Misty Odle
Madhavi Vemuri
Lin Yan
Data Guide Project Plan (1)
Project Plan:
– Review existing Data Guide examples and begin
discussion around content
– Identify “required” and optional/recommended
sections of content and develop clear We are here
descriptions
– Create best practice content (review, finalize)
– Repeat above process for format/structure
– Create proposed template for Data Guide
Data Guide Project Plan (2)
Project Plan:
– Proposal to FDA via sub-team representative
– Create master Data Guide incorporating FDA
feedback
– Review/Finalize
– Next Steps
Action Plan
• Form three work groups to further define intended
content and organization of content
– Study level
– Data description
– Data validation
Our work group
• Sub-team leads to compile updated template
• Sub-team members to pilot template and bring
results back to work group
• Obtain comment from sub-team and FDA
• Finalize and publish template
Activities completed to date
• Reviewed examples posted on Wiki from
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Doug Warfield
Pharmastat
CDISC SDTM Metadata Submission Guideline
Several others
• Summary of comments
– 8 people posted comments
– Focus was on template provided by Doug Warfield and
SDTM
• Suggestion: Develop SDTM Data Guide first and then go back to
ADaM
Discussion Question Responses
- General
• Generally positive comments on the template but
many comments/concerns on details of content
• Majority of respondents questioned duplication of
information found in SDTM documentation,
define.xml, or elsewhere in submission
– Suggestions to focus on information unique to the trial or
clarify areas of potential confusion
Discussion Question Responses
– Data Description
• aCRF
– Indicate if there are multiple data sources (secondary CRFs for
substudy, diary, etc)
– Indicate other data sources/forms not included in SDTM (e.g.,
operational forms processed by other functions such as SAEs)
– Explain any annotation conventions that might not be obvious to
reviewers
• CT
– Intent of section not clear
– Could be used to describe sponsor extensions to CDISC CT or mapping
of collected terms to standard CT
– Comment on level of adherence to CDISC CT
– Move after Domains section?
Discussion Question Responses
– Data Description
• Domains
– Focus on non-standard information; avoid duplication of
define.xml
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Custom domains
“Odd” mapping situations
Derived domains (e.g., EX)
Describe domains of primary importance
Whether data on screen failures submitted
Whether any domains not submitted due to no data
Explain data found in SUPP--, FA, RELREC
Assignment errors
Data cutoff
Aug 29 Attendees
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Gail Stoner – Lead√
Scott Bahlavooni
John Brega √
Nancy Brucken
John Franchino
Susan Kenny √
Steve Kirby √
Misty Odle
Madhavi Vemuri √
Lin Yan √
Notes from Aug 29 meeting
• See Data Description Sections Details.docx
– Reviewed and commented on Overview and aCRF sections
– Will begin with Domains section at next meeting
• General comments
– Standard format very important for reviewers – reduces
“noise”
– Important to pilot proposed template in 10-12 studies and
include in FDA review
– ADaM data guide may be a separate team
• Susan has examples of ADaM data guide to post
• Although content may differ, try for a common look and feel
Next Steps
• Next meeting Tues., Sep. 4 at 3 PM Eastern
• Agenda: Continue to discuss Data Description
Section Details document
– Start with Domains section
– CT section
– Rank value to reviewers
– Order/organize
Links
• phuse wiki home page
• FDA Working Groups home page
• Work Group 4: Standards Implementation
Issues
• Data Guide project