Difference between revisions of "Nonclinical Study Data Reviewers Guide"

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* Sample Nonclinical SDRG's developed by team members
 
* Sample Nonclinical SDRG's developed by team members
  
Click here to access the [[Study_Data_Reviewer's_Guide|Nonclinical SDRG Package V1.1]].  
+
[https://www.phuse.eu/css-deliverables '''Click here to access the current Nonclinical SDRG Package''']   
  
The Nonclinical SDRG package has been developed to comply with the FDA's [http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf Study Data Technical Conformance Guide]<br />
+
The Nonclinical SDRG package has been developed to comply with the FDA's Study Data Technical Conformance Guide.  The current version of this document can be found at the website: [https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources FDA Data Standards Resources]
  
Learn more about Nonclinical Topics Working Group of the PhUSE Computational Sciences Symposium, and its other projects @[[Nonclinical Topics Working Group]].  
+
Learn more about Nonclinical Topics Working Group of the PHUSE Computational Sciences Symposium, and its other projects @[[Nonclinical Topics Working Group]].  
 
<br />
 
<br />
 +
 +
=Current Work - 1Q2020=
 +
Preparing for next update of nsdrg template package<br /><br />
 +
 +
The team is working through a plan, applying the concepts of our Purpose (below) to issue the next version of the nsdrg template package for public review around the Computational Sciences Symposium in June 2020.  Inputs being reviewed for the next versions are:
 +
- Team meeting minutes
 +
- TCG updates
 +
- Feedback from Sponsors, CROs, data and system providers and FDA
 +
- Questions of CDISC Japan User Group
 +
 +
If you have input you would like to see considered in this process, please submit your suggestions to the [[SEND Implementation Forum]]
  
 
=Purpose=
 
=Purpose=
This year's project is to:<br />
+
Our team continues to work to:<br />
* continually maintain the Nonclinical Study Data Reviewers Guide (nSDRG), based on FDA's Technical Conformance Guide  
+
* maintain the Nonclinical Study Data Reviewers Guide (nSDRG), based on FDA's Technical Conformance Guide and any public feedback
 
* provide guidance on "best practices" for creating nSDRG
 
* provide guidance on "best practices" for creating nSDRG
* compare with anticipated potential requirements for Japanese regulatory submissions (new for 2017)
+
* compare with anticipated potential requirements from other regulatory authorities
 
* maintain alignment with the cSDRG, maintained by [[Optimizing the Use of Data Standards]] Working Group for Clinical Studies<br />
 
* maintain alignment with the cSDRG, maintained by [[Optimizing the Use of Data Standards]] Working Group for Clinical Studies<br />
 
<br>
 
<br>
=Discussion Forum =
+
==Got a question?==
  
==Forum==
+
The SEND Implementation Forum is a great place to ask questions and get answers!  If you have a question on nSDRG, feel free to post it [[SEND Implementation Forum|HERE on the FORUM]], and your question will be answered by SEND experienced folks in the PHUSE community.
 
 
<disqus></disqus>
 
 
 
 
 
----
 
 
 
Last revision by {{REVISIONUSER}}, {{REVISIONYEAR}}-{{REVISIONMONTH}}-{{REVISIONDAY}}
 
 
 
[[Category:SEND Implementation Forum]]
 
[[Category:SEND]]
 
[[Category:DISQUS]]
 
  
 
=Overview and Scope=
 
=Overview and Scope=
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<br>
 
<br>
 
=Current Published nSDRG Package=
 
=Current Published nSDRG Package=
'''The current package is available here, for public use.
+
[https://www.phuse.eu/css-deliverables '''The current package is available here, for public use'''.]  
'''[[Study_Data_Reviewer%27s_Guide]]
 
  
The package has been reviewed through a PhUSE public deliverable review in 2015, and an FDA review in 2016. Comments from these reviews, as well as from the FDA "Fit for Use" SEND Pilot are being incorporated into the next version of the package. Stay tuned for update announcements.<br />
+
This link will bring you to the PHUSE Deliverables page for PHUSE documents referenced by Regulatory guidances.  Scroll to mid-page to see the Nonclinical Study Data Reviewers' Guide guideline and template.
 +
 
 +
The nSDRG team continues to monitor FDA's Technical Conformance Guide updates (which occur  2X per year, expected in MAR and OCT) and also public comments received from users of nSDRG. As these new inputs are evaluated, we will post answers in the SEND Implementation Forum,  and update the published documents as needed. Stay tuned for update announcements.<br />
  
 
= Project Team =
 
= Project Team =
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|Debra.Oetzman || Co-Lead, software vendor || Instem || debra.oetzman@instem.com
 
|Debra.Oetzman || Co-Lead, software vendor || Instem || debra.oetzman@instem.com
 
|-
 
|-
|Paul Brown || Team member||US FDA||paul.brown@fda.hhs.gov
+
|Anja Metzger || Team member || Bayer || anja.metzger@bayer.com
 +
|-
 +
|Brett Coupland || Team member || Astrazeneca || brett.coupland@astrazeneca.com
 +
|-
 +
|Cathy Roy || Team member||Merck||catherine.roy@merck.com
 +
|-
 +
|Daniel Potenta || Team member||PDS Lifesciences||dan.potenta@pdslifesciences.com
 +
|-
 +
| Deepika V.G || Participant || Point Cross || deepika@pointcross.com
 +
|-
 +
|Christy Kubin || Team member|| MPI Research || christy.kubin@mpiresearch.com
 +
|-
 +
|Florence Halbert || Team member || Novartis || florence.halbert@novartis.com
 +
|-
 +
|Gitte Frausing || Team member || Data Standards Decisions || gfrausing@datastandardsdecisions.com
 +
|-
 +
|Haley Wulff || Team member || Basinc || hwulff@basinc.com
 +
|-
 +
|Hepei Chen || Team member || FDA || hepei.chen@fda.hhs.gov  
 +
|-
 +
|Karen Porter || Participant || Point Cross || karen@pointcross.com
 +
|-
 +
|Kenneth Hershman || Participant || Novartis|| kenneth.hershman@novartis.com
 +
|-
 +
|Linda Hunt || Team member||Merck||linda.hunt@merck.com
 +
|-
 +
|Lindsy Eickhoff || Team member || Basinc || leickhoff@basinc.com
 +
|-
 +
|Mandie Rhodes || Team member|| BMS || mandie.rhodes@bms.com
 
|-
 
|-
|Susie Lendal Antvorskov || Team member||Data Standards Decisions||slendal@datastandardsdecisions.com
+
| Matthew Whittaker || Team member || FDA || matthew.whittaker@fda.hhs.gov
 
|-
 
|-
|William Houser|| Team member||BMS||william.houser@bms.com
+
|Mark Carfagna || Team member || Lilly || carfagna_mark_a@lilly.com
 
|-
 
|-
|Jennifer Feldmann|| Team member||Instem||jennifer.feldmann@instem.com
+
|Michael Rosentreter || Team member || Bayer || michael.rosentreter@bayer.com
 
|-
 
|-
|Steve Polley|| Team member||GSK||steven.r.polley@gsk.com
+
|Maureen Rossi || Team member || roche || maureen.rossi@roche.com
 
|-
 
|-
 
|Nicola Robertson|| Team member||GSK||nicola.j.robertson@gsk.com
 
|Nicola Robertson|| Team member||GSK||nicola.j.robertson@gsk.com
 
|-
 
|-
|Tania Strimple|| Team member||Covance||tania.strimple@Covance.com
+
|Jack Baker || Team member || Covance || Jack.Baker@covance.com
 
|-
 
|-
|Cathy Roy || Team member||Merck||catherine.roy@merck.com
+
|Jennifer Abbott || Team member || Abbvie || jennifer.abbott@abbvie.com  
 
|-
 
|-
|Linda Hunt || Team member||Merck||linda.hunt@merck.com
+
|Jennifer Feldmann|| Team member||Epreda ||jennifer.feldmann@epreda.com
 
|-
 
|-
 
|Patricia Brundage|| Team member||FDA||patricia.brundage@fda.hhs.gov
 
|Patricia Brundage|| Team member||FDA||patricia.brundage@fda.hhs.gov
 
|-
 
|-
|Rick Thompson|| Team member||J&J|| RThompso@its.jnj.com
+
|Paul Brown || Team member||US FDA||paul.brown@fda.hhs.gov
 +
|-
 +
|Rick Thompson|| Team member||J&J|| rthompso@its.jnj.com
 +
|-
 +
| Senthil Palani || Team Member || Xybion || spalani@xybion.com
 +
|-
 +
|Steve Polley|| Team member||GSK||steven.r.polley@gsk.com
 
|-
 
|-
|Daniel Potenta || Team member||PDS Lifesciences||dan.potenta@pdslifesciences.com
+
|Susie Lendal Antvorskov || Team member||Data Standards Decisions||slendal@datastandardsdecisions.com
 +
|-
 +
|Tania Smith|| Team member||Covance||tania.strimple@Covance.com
 +
|-
 +
|William Houser|| Team member||BMS||william.houser@bms.com
 
|-
 
|-
 +
 +
 
|}
 
|}
  
 
=Plans=
 
=Plans=
''Projects:'' <br />
+
''Project objectives:'' <br />
*Implement the visioning process agree upon with PhUSE
+
*Implement the versioning process agreed upon with PHUSE
*Review and adapt as needed, comments provided by FDA from Public Review
+
*Review and adapt as needed, comments provided by FDA or Public Review
 
*Establish ongoing maintenance process
 
*Establish ongoing maintenance process
 
*Better address Section 6 for Legacy Data Conversion
 
*Better address Section 6 for Legacy Data Conversion
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*Maintain alignment with Clinical version
 
*Maintain alignment with Clinical version
  
 
<br />
 
''Meeting Plan:'' <br />
 
*Biweekly meetings are now held to work through template and guidance development
 
<br>
 
 
=Deliverables=
 
Next SDRG package <br />
 
<br />
 
 
=Next Meeting=
 
=Next Meeting=
 
'''We meet biweekly on Thurs at 11am Eastern time.'''  <br />
 
'''We meet biweekly on Thurs at 11am Eastern time.'''  <br />
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== Conference Calls and Minutes ==
 
== Conference Calls and Minutes ==
[[Nonclinical SDRG pilot project meeting minutes]]
+
nsdrg team meeting minutes are maintained in the PHUSE Project Team Space open to team members.
  
 
=Presentations=  
 
=Presentations=  
 
[http://www.phusewiki.org/wiki/images/0/0f/SDRG_Workshop_Outcomes_5Mar2018.pptx Maintaining the Clinical & Nonclinical Study Data Reviewers Guides CSS 2018 Workshop]
 
[http://www.phusewiki.org/wiki/images/0/0f/SDRG_Workshop_Outcomes_5Mar2018.pptx Maintaining the Clinical & Nonclinical Study Data Reviewers Guides CSS 2018 Workshop]
 
[http://www.phusewiki.org/wiki/images/9/9e/PhUSE_Webinar_Jan_24_final_SDRG_Workshop_deck.pptx Nonclinical & Clinical SDRG Workshop Webinar Wednesday 24th January 2018]
 
  
 
=Call for Members=
 
=Call for Members=
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=Working Documents=
 
=Working Documents=
 
==Next Version==
 
==Next Version==
[[Nonclinical SDRG Template and Guide]] - Working Drafts
+
[[Nonclinical SDRG Template and Guide]] - Working documents for next release
 
==Review Comments Tracker==
 
==Review Comments Tracker==
* [[http://www.phusewiki.org/wiki/index.php?title=File:Copy_of_Nonclin_SDRG_Public_Comments_Tracker.xlsx| nSDRG Comment Tracker]]
+
* [[http://www.phusewiki.org/wiki/index.php?title=File:Copy_of_Nonclin_SDRG_Public_Comments_Tracker.xlsx nSDRG Comment Tracker]]
 
==Archive==
 
==Archive==
2015 PhUSE Public Review: [[Nonclinical SDRG Template and Guide - Drafts for Public PhUSE Review]]
+
2015 PHUSE Public Review: [[Nonclinical SDRG Template and Guide - Drafts for Public PhUSE Review]]
 +
[http://www.phusewiki.org/wiki/index.php?title=Study_Data_Reviewer%27s_Guide Retired WIKI page for cSDRG and nSDRG] - documents now maintained on [https://www.phuse.eu/css-deliverables PhUSE Website for Deliverables]
 
<br />
 
<br />
 
<br>
 
<br>

Latest revision as of 15:49, 28 September 2020


Welcome the Nonclinical Study Data Reviewers Guide project Wiki!
The nSDRG package has been developed by this team and is available for public use:

  • Nonclinical Study Data Reviewers Guide - TEMPLATE
  • Nonclinical SDRG Guide with recommendations on how to use the template
  • Sample Nonclinical SDRG's developed by team members

Click here to access the current Nonclinical SDRG Package

The Nonclinical SDRG package has been developed to comply with the FDA's Study Data Technical Conformance Guide. The current version of this document can be found at the website: FDA Data Standards Resources

Learn more about Nonclinical Topics Working Group of the PHUSE Computational Sciences Symposium, and its other projects @Nonclinical Topics Working Group.

Current Work - 1Q2020

Preparing for next update of nsdrg template package

The team is working through a plan, applying the concepts of our Purpose (below) to issue the next version of the nsdrg template package for public review around the Computational Sciences Symposium in June 2020. Inputs being reviewed for the next versions are: - Team meeting minutes - TCG updates - Feedback from Sponsors, CROs, data and system providers and FDA - Questions of CDISC Japan User Group

If you have input you would like to see considered in this process, please submit your suggestions to the SEND Implementation Forum

Purpose

Our team continues to work to:

  • maintain the Nonclinical Study Data Reviewers Guide (nSDRG), based on FDA's Technical Conformance Guide and any public feedback
  • provide guidance on "best practices" for creating nSDRG
  • compare with anticipated potential requirements from other regulatory authorities
  • maintain alignment with the cSDRG, maintained by Optimizing the Use of Data Standards Working Group for Clinical Studies


Got a question?

The SEND Implementation Forum is a great place to ask questions and get answers! If you have a question on nSDRG, feel free to post it HERE on the FORUM, and your question will be answered by SEND experienced folks in the PHUSE community.

Overview and Scope

Preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a CDISC standards-compliant study data submission. The challenge is to operationalize this new documentation requirement efficiently and effectively.
Challenges we seek to answer with this project:

  • Provide a practical template for easy access and use
  • Provide guidance document which describes expected content and options to guide nonclinical SDRG authors.
  • Provide authors with examples, describing how to handle different data situations with SDRG content.

Things we expect to learn along the way:

  • Exploration of ways to generate the nonclinical SDRG and who should do the job.
  • The SDRG is expected to be useful by FDA reviewers. Can it also be useful for other nonclinical study stakeholders?
  • Will the SDRG evolve as systems and processes gain expertise in the new SEND requirements for submission of nonclinical data?


Current Published nSDRG Package

The current package is available here, for public use.

This link will bring you to the PHUSE Deliverables page for PHUSE documents referenced by Regulatory guidances. Scroll to mid-page to see the Nonclinical Study Data Reviewers' Guide guideline and template.

The nSDRG team continues to monitor FDA's Technical Conformance Guide updates (which occur 2X per year, expected in MAR and OCT) and also public comments received from users of nSDRG. As these new inputs are evaluated, we will post answers in the SEND Implementation Forum, and update the published documents as needed. Stay tuned for update announcements.

Project Team

Name Role Organization E-mail
Susan DeHaven Co-Lead, pharma Sanofi susan.dehaven@sanofi.com
Debra.Oetzman Co-Lead, software vendor Instem debra.oetzman@instem.com
Anja Metzger Team member Bayer anja.metzger@bayer.com
Brett Coupland Team member Astrazeneca brett.coupland@astrazeneca.com
Cathy Roy Team member Merck catherine.roy@merck.com
Daniel Potenta Team member PDS Lifesciences dan.potenta@pdslifesciences.com
Deepika V.G Participant Point Cross deepika@pointcross.com
Christy Kubin Team member MPI Research christy.kubin@mpiresearch.com
Florence Halbert Team member Novartis florence.halbert@novartis.com
Gitte Frausing Team member Data Standards Decisions gfrausing@datastandardsdecisions.com
Haley Wulff Team member Basinc hwulff@basinc.com
Hepei Chen Team member FDA hepei.chen@fda.hhs.gov
Karen Porter Participant Point Cross karen@pointcross.com
Kenneth Hershman Participant Novartis kenneth.hershman@novartis.com
Linda Hunt Team member Merck linda.hunt@merck.com
Lindsy Eickhoff Team member Basinc leickhoff@basinc.com
Mandie Rhodes Team member BMS mandie.rhodes@bms.com
Matthew Whittaker Team member FDA matthew.whittaker@fda.hhs.gov
Mark Carfagna Team member Lilly carfagna_mark_a@lilly.com
Michael Rosentreter Team member Bayer michael.rosentreter@bayer.com
Maureen Rossi Team member roche maureen.rossi@roche.com
Nicola Robertson Team member GSK nicola.j.robertson@gsk.com
Jack Baker Team member Covance Jack.Baker@covance.com
Jennifer Abbott Team member Abbvie jennifer.abbott@abbvie.com
Jennifer Feldmann Team member Epreda jennifer.feldmann@epreda.com
Patricia Brundage Team member FDA patricia.brundage@fda.hhs.gov
Paul Brown Team member US FDA paul.brown@fda.hhs.gov
Rick Thompson Team member J&J rthompso@its.jnj.com
Senthil Palani Team Member Xybion spalani@xybion.com
Steve Polley Team member GSK steven.r.polley@gsk.com
Susie Lendal Antvorskov Team member Data Standards Decisions slendal@datastandardsdecisions.com
Tania Smith Team member Covance tania.strimple@Covance.com
William Houser Team member BMS william.houser@bms.com

Plans

Project objectives:

  • Implement the versioning process agreed upon with PHUSE
  • Review and adapt as needed, comments provided by FDA or Public Review
  • Establish ongoing maintenance process
  • Better address Section 6 for Legacy Data Conversion
  • Review, and adapt as needed, to periodic revisions of Technical Conformance Guide
  • Develop new example studies for new types included in SEND 3.1
  • Maintain alignment with Clinical version

Next Meeting

We meet biweekly on Thurs at 11am Eastern time.
To be invited, please contact: Debra Oetzman or Susan DeHaven
You will be welcomed!

Conference Calls and Minutes

nsdrg team meeting minutes are maintained in the PHUSE Project Team Space open to team members.

Presentations

Maintaining the Clinical & Nonclinical Study Data Reviewers Guides CSS 2018 Workshop

Call for Members

People likely interested in our topic: Toxicologists, Data managers preparing SEND data sets, Nonclinical study reviewers (FDA, Sponsor or other), relevant software vendors. What is the commitment?

  • Time will vary with a minimum of 1 hour, every 2 weeks for meeting attendance + 1-2 hours between for authoring, reviewing and assessing outcomes.
  • Attendance to the PHUSE Computational Sciences Symposium conference is not required.

If you would like to participate, please contact one of the Project Co-leads.


Working Documents

Next Version

Nonclinical SDRG Template and Guide - Working documents for next release

Review Comments Tracker

Archive

2015 PHUSE Public Review: Nonclinical SDRG Template and Guide - Drafts for Public PhUSE Review Retired WIKI page for cSDRG and nSDRG - documents now maintained on PhUSE Website for Deliverables