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

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m (Overview & Scope: added module 4 to scope to cover the new SEND related SDRG)
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|colspan="4" style="text-align:center;"|'''Non-Clinical Study Data Reviewer's Guide<sup>1</sup>'''
|colspan="4" style="text-align:center;"|'''Non-Clinical Study Data Reviewer's Guide<sup>1</sup>'''
|Final Draft||06-Aug-2015||'''[[Media:NonClinicalSDRG_FinalDraft_20150806.zip|Non-Clinical SDRG Package Final Draft 2015-08-06]]'''||Final draft
|v1.0||03-Mar-2016||'''[[Media:NonClinicalSDRG_FinalDraft_20150806.zip|Non-Clinical SDRG Package Final Draft 2015-08-06]]'''||Final draft

Revision as of 22:08, 2 March 2016

Study Data Reviewer's Guide Final Work Package

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
Non-Clinical Study Data Reviewer's Guide1
v1.0 03-Mar-2016 Non-Clinical SDRG Package Final Draft 2015-08-06 Final draft

1. The Non-Clinical SDRG is a different work package from the Clinical SDRG. FR Notice 2015-18027 applies to the Clinical SDRG only. A separate FR Notice will be issued for the Non-Clinical SDRG.

Study Data Reviewer's Guide Project

Overview & Scope

CGD-010: define.XML does not adequately document SDTM 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) will be proposed as a component of the eCTD's Module 4 (preclinical) and 5 (clinical) SDTM data documentation.  This document will be defined for SDTM data descriptions only. An Analysis Data Reviewer's Guide will be handled in a future project.

SDRG 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 scottab@gene.com, Genentech
John Brega, Pharmastat

Final SDRG Work Package

Final SDRG Work Package v1.1 - Includes: SDRG Completion Guidelines, SDRG Template, and Example SDRGs
Please review Readme.txt for a complete description of all files in the work package.

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

SDRG Project Plan

SDRG Completion Instructions first draft: 29Oct2012 - 02Nov2012
SDRG Template first draft: 29Oct2012 - 15Nov2012
Pre-qualification of SDRG Instructions: 05Nov2012 - 30Nov2012
Compile findings from pre-qualification and finalize SDRG Instructions and Template: 01Dec2012 - 15Dec2012
Identify data for development of SDRG Examples including authorization from sponsor companies to permit the use of "dummied" references to corporate data in examples: 29Oct2012 - 15Dec2012
SDRG Examples: 01Jan2013 - 30Jan2013
WG4 Review of SDRG Deliverable Package 31Jan2013 - 28Feb2013

Archived Content

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

Keep it small, keep it simple, keep it moving