Study Data Reviewer's Guide
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||
|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 for Federal Register Notice Docket No. FDA-2016-N-0701 -Public Review|
Applicable Federal Register Notices:
FR Notice 2015-18027 applies to the Clinical SDRG only. The public review period on this notice has ended.
FR Notice 2016-04791 applies to the Nonclinical SDRG only The public review period on this notice opens 4 March 2016. Click on the FR Notice link to find out how to comment.
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
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
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