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

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__NOTOC__
  
= Study Data Reviewer's Guide Final Work Package =
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= Study Data Reviewer's Guide Final Work Packages =
 
<br>
 
<br>
 
{| class="wikitable"
 
{| class="wikitable"
 
|-
 
|-
! Version !! Release Date!!Downloadable Work Package !! Changes from Previous Version !!
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| Version || Release Date || Downloadable Work Package || Changes from Previous Version ||
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|-
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|colspan="4" style="text-align:center;"|'''Clinical Study Data Reviewer's Guide'''
 
|-
 
|-
|v1.2||26-Jan-2015||'''[[Media:SDRG_v1.2_2015-01-26.zip|Final SDRG Package v1.2 2015-01-26]]'''||
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|v1.2||26-Jan-2015||'''[[Media:SDRG_v1.2_2015-01-26.zip|SDRG Package v1.2 2015-01-26]]'''||
 
* Removed Trial Design Dataset navigation table from Section 2.3  
 
* Removed Trial Design Dataset navigation table from Section 2.3  
* Minor formatting updates
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* 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||'''[[Media:SDRG v1.1 2013-05-13.zip|SDRG Package v1.1 2013-05-13]]'''||Initial Version
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|-
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|colspan="4" style="text-align:center;"|'''Nonclinical Study Data Reviewer's Guide'''
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|-
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|v1.0||03-Mar-2016||'''[[Media:Nonclinical_SDRG_Review_Package.zip|nSDRG Package v1.0 2016-03-03]]'''||Initial Version
 
|-
 
|-
|v1.1||03-May-2013||'''[[Media:SDRG v1.1 2013-05-13.zip|Final SDRG Package 2013-05-13]]'''||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]]'''||
 +
*More description added to Guideline from public and FDA reviews
 +
*Improved consistency of template and guideline to SENDIG
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*nSDRG samples not updated yet for this package
 
|-
 
|-
 
|}
 
|}
 +
Applicable Federal Register Notices:<br />
 +
[https://federalregister.gov/a/2015-18027 FR Notice 2015-18027] applied to the Clinical SDRG only. The public review period on this notice has ended.<br />
 +
[https://federalregister.gov/a/2016-04791 FR Notice 2016-04791] applied to the Nonclinical SDRG only. The public review period on this notice has ended.
 
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<br>
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= Study Data Reviewer's Guide Project =
 
== Overview & Scope ==
 
== 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.<br /><br />
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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.<br /><br />
Scope: The Study Data Reviewer's Guide (SDRG) will be proposed as a component of the eCTD's Module 5 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.
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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.  
 
<br />
 
<br />
  
== SDRG Core Team ==
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== cSDRG Core Team ==
  
 
Helena Sviglin, FDA<br>
 
Helena Sviglin, FDA<br>
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Gail Stoner [mailto:GStoner@its.jnj.com GStoner@its.jnj.com], J&J <br>
 
Gail Stoner [mailto:GStoner@its.jnj.com GStoner@its.jnj.com], J&J <br>
 
Joanna Koft [mailto:joanna.koft@biogenidec.com joanna.koft@biogenidec.com], Biogen Idec <br>
 
Joanna Koft [mailto:joanna.koft@biogenidec.com joanna.koft@biogenidec.com], Biogen Idec <br>
Scott Bahlavooni [mailto:scottab@gene.com scottab@gene.com], Genentech<br>
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Scott Bahlavooni <br />
 
John Brega, Pharmastat<br>
 
John Brega, Pharmastat<br>
 
<br />
 
<br />
  
== Final SDRG Work Package ==
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== nSDRG Team Leaders ==
[[media:SDRG_v1.1_2013-05-13.zip|Final SDRG Work Package v1.1]] - Includes: SDRG Completion Guidelines, SDRG Template, and Example SDRGs <br>
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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 />
 +
Robert Dorsam and Patricia Brundage, FDA liaisons for the project<br />
 +
 
 +
== Final SDRG Work Packages ==
 +
[[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>
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 +
<br />
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[[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]].
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Additional feedback for either package can be provided by adding a comment to the [[Talk:Study Data Reviewer's Guide|Discussion Tab]].
<br />
 
 
 
== SDRG Project Plan ==
 
SDRG Completion Instructions first draft: 29Oct2012 - 02Nov2012 <br>
 
SDRG Template first draft: 29Oct2012 - 15Nov2012<br>
 
Pre-qualification of SDRG Instructions: 05Nov2012 - 30Nov2012<br>
 
Compile findings from pre-qualification and finalize SDRG Instructions and Template: 01Dec2012 - 15Dec2012<br>
 
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<br>
 
SDRG Examples: 01Jan2013 - 30Jan2013<br>
 
WG4 Review of SDRG Deliverable Package 31Jan2013 - 28Feb2013<br>
 
 
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[[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>
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[[Data_Guide_-_SDRG Project Plan|Data Guide Development - SDRG Project Plan]]<br>
 
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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





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