Best Practices for Data Collection Instructions

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Presentation transcript:

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

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

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

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)

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

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

Project Logistics Meetings: 1st and 3rd Friday of each month for 6 months Project Details/Meeting Minutes http://www.phusewiki.org/wiki/index.php?title=Best_Practices_for_Data_Collection_Instructions Project Co-lead? Sharing Company Specific Information

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)