1. Best Practices for Data Collection Instructions
Kick-off Meeting
19-May-2017

2. Agenda Introductions and Overview Project Overview Project Logistics
Disposition: Reason For Treatment and Study Discontinuation

3. Introductions Todd Bazin (Lead) Biogen Tina Lambert Astellas
Lisa Houterloot Lilly
Shannon Labout CDISC
Jeannine Hughes Boehringer-Ingelheim
Elizabeth Langevin Takeda
Aparna Kulkarni Novartis
Charity Quick Rho
Kit Howard CDISC
Wendy Dobson PhUSE
Mary Nilsson Lilly *Consulted as Needed
Jane Lozano Lilly *Consulted as Needed

4. Project Overview (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) and fewer queries (less confusion by site personnel)

5. Project Overview (Scope)
Define Best Practice Collection Instructions for the Following:
Medical History
Concomitant Medications/Non-Drug Treatments
Adverse Events
Pregnancy
Reasons for Treatment and Study Discontinuation

6. Project Overview (Key Notes/Deliverables)
Collaboration with CDISC’s CDASH team
Key Deliverable – White Paper
Detailed Completion Instructions for the 5 defined topics
Recommendations to the CDASH team for potential integration into a future implementation guide

7. Project Logistics
Meetings: 1st and 3rd Friday of each month for 6 months
Project Details/Meeting Minutes
Project Co-lead?
Sharing Company Specific Information

8. Reasons for Treatment and Study Discontinuation
See Section 6.3 of the demographic/disposition/medication white paper
For analyses, team wants reason for treatment AND reason for study discontinuation (can and should be different in many cases) for each phase (i.e. epoch)
Submission Data Standards (SDS) subteam worked out solutions for having multiple disposition events per epoch and how to handle the situation when multiple drugs are given in a study and a subject discontinues only a part of the regimen (will be reflected in SDTM version 3.3)