August 21, 2014
Subgroup Organization Alignment Proposal for Target Deliverables CBER checklist Additional Suggestions Next Steps Questions
The Standardization Plan should include, but is not limited to the following: 1. List of the planned studies 2. Type of studies (e.g., phase I, II or III) 3. Study designs (e.g., parallel, cross-over, open-label extension) 4. Planned data standards, formats, and terminologies and their versions 5. List of and justification for studies that may not conform to the standards
FacilitateMembers List of Planned Studies (Clinical) (include study start date - PA or FPV?) MichaelTony Chang Kristin Kelley List of Planned Studies (Non-Clinical) (include study start date - PA or FPV?) MichaelLaura Kaufman Peggy Zorn Plan for Pooled AnalysisJaneSusan Kenny Pam Ryley Plan for Legacy Data ConversionJaneSteven Kirby Beate Hientzsch Laura Kaufman Standards & Controlled Terminologies Jane Nick Naro Linda Simonsson Cathy Bezek MaryBeth Blauwet Peggy Zorn
FacilitateMembers Management & Versioning of the Plan Questions for FDAMichaelAnne Russotto Tony Chang Completion Guidelines & SamplesMichaelJane Lozano
Michael and Jane will lead separate meetings to participate in and facilitate completion of the sections assigned Sections to be drafted by mid-October. Draft version of the plan template to be completed by first week of December Completion Guidelines & Samples to be completed by the end of February 2015.
Versioning and updating of the plan along with timing (e.g. with the annual report or when IB is updated) Efficacy endpoints related to the development program Aligning the table of studies to be similar to that in the CDP and the Table of studies inserted in Module 2 of an NDA or PLA application to provide consistency across a program
Mike and Jane will follow up with the groups in the next 2 weeks. Subgroup meetings to occur at least every 2 weeks. Group meetings to occur once a month. Jane will update the PhUSE Wiki Site with minutes from the prior meeting and this meeting.