Difference between revisions of "Study Data Reviewer's Guide"

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= Study Data Reviewer's Guide Final Work Package =
= Study Data Reviewer's Guide Final Work Packages =
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Revision as of 21:04, 8 December 2016

Study Data Reviewer's Guide Final Work Packages

Version Release Date Downloadable Work Package Changes from Previous Version
Clinical Study Data Reviewer's Guide
v1.2 26-Jan-2015 SDRG Package v1.2 2015-01-26
  • Removed Trial Design Dataset navigation table from Section 2.3
  • Improved SDRG Template usability
  • Minor revisions to instructions in SDRG Completion Guidelines
  • SDRG Examples updated to match revised SDRG Template
v1.1 03-May-2013 SDRG Package v1.1 2013-05-13 Initial Version
Nonclinical Study Data Reviewer's Guide
v1.0 03-Mar-2016 Nonclinical SDRG Package v1.0 2016-03-03 v1.0 Initial Version

Applicable Federal Register Notices:
FR Notice 2015-18027 applied to the Clinical SDRG only. The public review period on this notice has ended.
FR Notice 2016-04791 applied to the Nonclinical SDRG only. The public review period on this notice has ended.

Study Data Reviewer's Guide Project

Overview & Scope

CGD-010: define.XML does not adequately document SDTM & SEND mapping decisions, sponsor-defined domains, sponsor-defined controlled terminology, and sponsor extensions to CDISC controlled terminology. A standardized Data Guide would help to address this documentation gap. The content of the Data Guide should be standardized and developed jointly between CDER, Industry, and CDISC.

Scope: The Study Data Reviewer's Guide (SDRG) is recommended as a component of the eCTD's Module 4 (nonclinical) and 5 (clinical) SEND & SDTM dataset documentation.  

cSDRG Core Team

Helena Sviglin, FDA
Douglas Warfield, FDA
Gail Stoner GStoner@its.jnj.com, J&J
Joanna Koft joanna.koft@biogenidec.com, Biogen Idec
Scott Bahlavooni
John Brega, Pharmastat

nSDRG Team Leaders

Susan DeHaven susan.dehaven@sanofi.com, Sanofi
Debra Oetzman debra.oetzman@instem.com, Instem
Laura Kaufman lkaufman@eagleus.com, Eagle
Robert Dorsam and Patricia Brundage, FDA liaisons for the project

Final SDRG Work Packages

Current cSDRG Package v1.2 2015-01-26 - Includes: SDRG Completion Guidelines, SDRG Template, and Example SDRGs
Please review Readme.txt for a complete description of all files in the work package.

Current nSDRG Package v1.0 2016-03-03- Includes: nSDRG Completion Guidelines, nSDRG Template, and Example nSDRGs

Additional feedback for either package can be provided by adding a comment to the Discussion Tab.

Archived Content

Data Guide - An Analysis, FDA Template, Examples
Data Guide Development - Study Level
Data Guide Development - Data Description
Data Guide Devlopment - Data Validation
Data Guide Development - SDRG Project Plan

Keep it small, keep it simple, keep it moving