2. In-Depth Report from Optimizing Data Standards Working Group
Todd Bazin (Biogen)

3. Background
The Optimizing Use of Data Standards WG is tasked with identifying specific gaps that prevent FDA and industry from optimizing the use of data standards and then improving industry practices so as to increase efficiencies
The WG oversees projects that close the gaps, which includes providing document templates identified in FDA guidance

4. What are the Working Group Projects?
Best Practices for Data Collection Instructions
Best Practices for Metadata Documentation (define xml vs. reviewer’s guide)
Data Reviewer’s Guide in XML
Define v2.0 Completion Guidelines & Style Sheet Recommendations
Legacy Data Conversion Plan & Report
Pooling WHO Drug B3 Format
SDTM ADaM Implementation FAQ
Study Data Standardization Plan

5. Best Practices for Data Collection Instructions Project Lead: Todd Bazin - Biogen
Project Overview (The ‘Why’)
Spin-off project from PhUSE’s Standard Analysis and Code Sharing Working Group
Variations in collection instructions limit the ability to achieve some of the defined standard analyses and the ability to fully realize the vision of sharing and co-developing scripts
Creating best practices in collection instructions should facilitate additional standardization
Will potentially lead to increased efficiency (site personnel won't have to learn as many collection methods), higher quality and consistent data, and fewer queries (less confusion by site personnel)

6. Best Practices for Data Collection Instructions (cont.)
Project Scope
Define Best Practice Collection Instructions for the Following:
Disposition (End of Screening, End of Treatment, End of Study)
Adverse Events
Medical History
Concomitant Medications / Non-Drug Treatments
Project Deliverables
Short Term: PhUSE white paper detailing best practice recommendations for domains noted above
Long Term: Continued collaboration with CDASH team and potential integration into a future CDASH implementation guide

7. Best Practices for Data Collection Instructions (cont.)
Project Status
Disposition (End of Screening, End of Treatment, End of Study)
Key Questions project team is actively working to answer:
When should a disposition record be collected? (e.g. end of screening epoch, end of treatment, end of study)
What discontinuation reasons / sub-reasons are recommended for each disposition CRF based on SDTM controlled terminology and real world data?
What completion instructions language should be included for each CRF & discontinuation reason

8. Best Practices for Data Collection Instructions (cont.)
Disposition Example
Core principles:
Safety/Efficacy reasons listed first
Avoid vague reasons such as withdrawal by subject, physician decision, lost to follow-up, other
Utilize sub-options based on real world data to ensure non-safety/efficacy related
Limit the collection of free text

9. Best Practices for Data Collection Instructions (cont.)
Project Status
Medical History
Key Questions project team working to answer:
Collect ALL events or only ‘Significant / Relevant’ events
If collect start/stop dates: How to handle events that are ongoing at screening but resolve during the study?

10. Best Practices for Data Collection Instructions (cont.)
Project Status
Adverse Events
Key Questions project team working to answer:
Collect all SAEs and AEs after signing ICF?
Or collect all SAEs after signing ICF and only AEs after date/time of first study treatment? (Events between ICF and first treatment recorded on MH)?
Collect distinct records for AEs that worsen?
Or collect distinct records for AEs that worsen or improve?

11. Best Practices for Data Collection Instructions (cont.)
Project Logistics
Meetings: 1st and 3rd Friday of each month
Project Details/Meeting Minutes