Transcript PhUSE Study Data Standardization Plan

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
Facilitate
Members
List of Planned Studies (Clinical)
(include study start date - PA or FPV?)
Michael
Tony Chang
Kristin Kelley
List of Planned Studies (Non-Clinical)
(include study start date - PA or FPV?)
Michael
Laura Kaufman
Peggy Zorn
Plan for Pooled Analysis
Jane
Susan Kenny
Pam Ryley
Plan for Legacy Data Conversion
Jane
Steven Kirby
Beate Hientzsch
Laura Kaufman
Standards & Controlled Terminologies
Jane
Nick Naro
Linda Simonsson
Cathy Bezek
MaryBeth Blauwet
Peggy Zorn
Facilitate
Members
Questions for FDA
Michael
Anne Russotto
Tony Chang
Completion Guidelines & Samples
Michael
Jane Lozano
Management & Versioning of the Plan
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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.
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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
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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.