Nonclinical Study Data Reviewers Guide

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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


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
Debra.Oetzman Co-Lead, software vendor Instem
Anja Metzger Team member Bayer
Brett Coupland Team member Astrazeneca
Cathy Roy Team member Merck
Daniel Potenta Team member PDS Lifesciences
Deepika V.G Participant Point Cross
Christy Kubin Team member MPI Research
Florence Halbert Team member Novartis
Gitte Frausing Team member Data Standards Decisions
Haley Wulff Team member Basinc
Hepei Chen Team member FDA
Karen Porter Participant Point Cross
Kenneth Hershman Participant Novartis
Linda Hunt Team member Merck
Lindsy Eickhoff Team member Basinc
Mandie Rhodes Team member BMS
Matthew Whittaker Team member FDA
Mark Carfagna Team member Lilly
Michael Rosentreter Team member Bayer
Maureen Rossi Team member roche
Nicola Robertson Team member GSK
Jack Baker Team member Covance
Jennifer Abbott Team member Abbvie
Jennifer Feldmann Team member Epreda
Patricia Brundage Team member FDA
Paul Brown Team member US FDA
Rick Thompson Team member J&J
Senthil Palani Team Member Xybion
Steve Polley Team member GSK
Susie Lendal Antvorskov Team member Data Standards Decisions
Tania Smith Team member Covance
William Houser Team member BMS


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.


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


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