PhUSE Study Data Standardization Plan

August 21, 2014

Subgroup Organization Alignment

Proposal for Target DeliverablesCBER checklistAdditional SuggestionsNext StepsQuestions

SDSP Agenda

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

SDSP Requirements

Facilitate Members

List of Planned Studies (Clinical) (include study start date - PA or FPV?)

Michael Tony ChangKristin Kelley

List of Planned Studies (Non-Clinical)(include study start date - PA or FPV?)

Michael Laura KaufmanPeggy Zorn

Plan for Pooled Analysis Jane Susan KennyPam Ryley

Plan for Legacy Data Conversion Jane Steven KirbyBeate HientzschLaura Kaufman

Standards & Controlled TerminologiesJane

Nick NaroLinda SimonssonCathy BezekMaryBeth BlauwetPeggy Zorn

SDSP Subgroup Organization

Facilitate Members

Management & Versioning of the Plan

Questions for FDA Michael Anne RussottoTony Chang

Completion Guidelines & Samples Michael Jane Lozano

SDSP Subgroup Organization

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 2014. Completion Guidelines & Samples to be

completed by the end of February 2015.

Proposal for Target Deliverables

CBER Checklist

CBER Checklist

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

Additional Suggestions

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.

Next Steps

Questions?