FDA/PhUSE Collaboration: Study Data Reviewer’s Guide Work Package v1.1 Available
The Study Data Reviewer´s Guide Template, a creation of the FDA/PhUSE Working Group collaboration is now available. The Study Data Reviewer´s Guide documents, in a human-readable way, data life-cycle decisions to aid the FDA review of licensing applications.
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: http://www.phusewiki.org/wiki/index.php?title=Study_Data_Reviewer%27s_Guide.
An Analysis Data Reviewer’s Guide (ADRG) will be handled as a future project.
PhUSE, Share — Contribute — Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer-supported, community of professionals who are passionate about advancement of clinical information. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.
For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2013/5/prweb10714295.htm