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

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|colspan="4" style="text-align:center;"|'''Nonclinical Study Data Reviewer's Guide'''
 
|colspan="4" style="text-align:center;"|'''Nonclinical Study Data Reviewer's Guide'''
 
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|v1.0||03-Mar-2016||'''[[Media:Nonclinical_SDRG_Review_Package.zip|Nonclinical SDRG Package v1.0 2016-03-03]]'''||v1.0 Initial Version
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|v1.0||03-Mar-2016||'''[[Media:Nonclinical_SDRG_Review_Package.zip|nSDRG Package v1.0 2016-03-03]]'''||Initial Version
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|v1.1||19-Mar-2017||'''[[Media:NSDRG Package v1.1 2017-03-19.zip|nSDRG Package v1.1 2017-03-19]]'''||
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*More description added to Guideline from public and FDA reviews
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*Improved consistency of template and guideline to SENDIG
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*nSDRG samples not updated yet for this package
 
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Susan DeHaven [mailto:susan.dehaven@sanofi.com susan.dehaven@sanofi.com], Sanofi<br />
 
Susan DeHaven [mailto:susan.dehaven@sanofi.com susan.dehaven@sanofi.com], Sanofi<br />
 
Debra Oetzman [mailto:debra.oetzman@instem.com debra.oetzman@instem.com], Instem<br />
 
Debra Oetzman [mailto:debra.oetzman@instem.com debra.oetzman@instem.com], Instem<br />
Laura Kaufman [mailto:lkaufman@eagleus.com lkaufman@eagleus.com], Eagle <br />
 
 
Robert Dorsam and Patricia Brundage, FDA liaisons for the project<br />
 
Robert Dorsam and Patricia Brundage, FDA liaisons for the project<br />
  

Revision as of 22:11, 18 March 2017


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 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
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





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