Study Data Reviewer's Guide
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||
|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||
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
nSDRG Team Leaders
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.
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