Study Data Reviewer's Guide

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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 nSDRG Package v1.0 2016-03-03 Initial Version
v1.1 19-Mar-2017 nSDRG Package v1.1 2017-03-19
  • More description added to Guideline from public and FDA reviews
  • Improved consistency of template and guideline to SENDIG
  • nSDRG samples not updated yet for this package

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, J&J
Joanna Koft, Biogen Idec
Scott Bahlavooni
John Brega, Pharmastat

nSDRG Team Leaders

Susan DeHaven, Sanofi
Debra Oetzman, Instem
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