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

From PHUSE Wiki
Jump to: navigation, search
m (Study Data Reviewer's Guide Final Work Packages)
 
(6 intermediate revisions by one other user not shown)
Line 1: Line 1:
 
__NOTOC__  
 
__NOTOC__  
  
= Study Data Reviewer's Guide Final Work Package =
+
= Study Data Reviewer's Guide Final Work Packages =
 
<br>
 
<br>
 
{| class="wikitable"
 
{| class="wikitable"
 
|-
 
|-
! Version !! Release Date!!Downloadable Work Package !! Changes from Previous Version !!
+
| Version || Release Date || Downloadable Work Package || Changes from Previous Version ||
 
|-
 
|-
 
|colspan="4" style="text-align:center;"|'''Clinical Study Data Reviewer's Guide'''
 
|colspan="4" style="text-align:center;"|'''Clinical Study Data Reviewer's Guide'''
Line 19: Line 19:
 
|colspan="4" style="text-align:center;"|'''Nonclinical Study Data Reviewer's Guide'''
 
|colspan="4" style="text-align:center;"|'''Nonclinical Study Data Reviewer's Guide'''
 
|-
 
|-
|v1.0||03-Mar-2016||'''[[Media:Nonclinical_SDRG_Review_Package.zip|Nonclinical SDRG Package v1.0 2016-03-03]]'''||v1.0 Initial Version
+
|v1.0||03-Mar-2016||'''[[Media:Nonclinical_SDRG_Review_Package.zip|nSDRG Package v1.0 2016-03-03]]'''||Initial Version
 +
|-
 +
|v1.1||19-Mar-2017||'''[[Media:NSDRG Package v1.1 2017-03-19.zip|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
 
|-
 
|-
 
|}
 
|}
Line 48: Line 53:
 
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 />
  
== Final SDRG Work Package ==
+
== Final SDRG Work Packages ==
[[media:SDRG_v1.1_2013-05-13.zip|Final cSDRG Work Package v1.1]] - Includes: SDRG Completion Guidelines, SDRG Template, and Example SDRGs <br>
+
[[Media:SDRG_v1.2_2015-01-26.zip|Current cSDRG Package v1.2 2015-01-26]] - Includes: SDRG Completion Guidelines, SDRG Template, and Example SDRGs <br>
 
Please review Readme.txt for a complete description of all files in the work package. <br>
 
Please review Readme.txt for a complete description of all files in the work package. <br>
<br>
+
 
Additional feedback can be provided by adding a comment to the [[Talk:Study Data Reviewer's Guide|Discussion Tab]].
 
 
<br />
 
<br />
[[Media:Nonclinical_SDRG_Review_Package.zip|Nonclinical SDRG Package v1.0 2016-03-03]]- Includes: nSDRG Completion Guidelines, nSDRG Template, and Example nSDRGs <br>
+
[[Media:NSDRG_Package_v1.1_2017-03-19.zip|Current nSDRG Package v1.0 2016-03-03]]- Includes: nSDRG Completion Guidelines and nSDRG Template.<br>
 
<br>
 
<br>
Additional feedback can be provided by adding a comment to the [[Talk:Study Data Reviewer's Guide|Discussion Tab]].
+
Additional feedback for either package can be provided by adding a comment to the [[Talk:Study Data Reviewer's Guide|Discussion Tab]].
 
<br />
 
<br />
  
Line 67: Line 70:
 
[[Data_Guide_Data_Description|Data Guide Development - Data Description]]<br>
 
[[Data_Guide_Data_Description|Data Guide Development - Data Description]]<br>
 
[[Data_Guide_-_Data_Validation|Data Guide Devlopment - Data Validation]] <br>
 
[[Data_Guide_-_Data_Validation|Data Guide Devlopment - Data Validation]] <br>
[[Data_Guide_-_SDRG Project Plan]]<br>
+
[[Data_Guide_-_SDRG Project Plan|Data Guide Development - SDRG Project Plan]]<br>
 
<br>
 
<br>
 
<br>
 
<br>

Latest revision as of 06:47, 20 March 2018


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 and nSDRG Template.

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