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FDA/PhUSE Collaboration: Study Data Reviewer’s Guide Work Package v1.1 Available
Date:5/16/2013

Silver Spring, MD (PRWEB) May 16, 2013

PhUSE announces the availability of the Study Data Reviewer’s Guide (SDRG) Template. The FDA is currently reviewing the implementation/utility of this document and encourages sponsors to provide feedback. The Study Data Reviewer’s Guide is a proposed addition to module 5 of the eCTD which is submitted to the FDA for any drug, biologic or device application. Along with the define.xml the Study Data Reviewer’s Guide documents, in a human-readable way, decisions made during the data life-cycle like SDTM mapping decisions, sponsor-defined domains, sponsor-defined controlled terminology, and sponsor extensions to CDISC controlled terminology. A standardized Data Guide will provide the regulators with needed documentation to more thoroughly understand the submitted data.

The SDRG was created out of an industry/FDA collaboration initiated through PhUSE. PhUSE supports five working groups which provide the pharmaceutical industry with a platform to collaborate with experts, regulators, and other parties to create efficiencies in drug development. PhUSE Working Groups are focused on five crucial topics: Improving Data Quality, Optimizing the Use of Data Standards, Development of Standard Scripts for Analysis and Programming, Non-Clinical Roadmap and Impacts on Implementation, and Emerging Technologies.

“The SDRG demonstrates the power of volunteer collaboration; out of the efforts of a small but dedicated group an industry-wide change can be implemented,” Daniel Boisvert, Chair PhUSE Board of Directors.

The SDRG core team was led by Helena Sviglin, FDA; Douglas Warfield, FDA; Gail Stoner, J&J; Joanna Koft, Biogen Idec; Scott Bahlavooni, Genentech; and John Brega, Pharmastat.

The SDRG package can be downloaded from the PhUSE wiki: '/>"/>

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