Nonclinical Study Data Reviewers Guide
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 Nonclinical SDRG Package V1.1.
The Nonclinical SDRG package has been developed to comply with the FDA's Study Data Technical Conformance Guide
Learn more about Nonclinical Topics Working Group of the PhUSE Computational Sciences Symposium, and its other projects @Nonclinical Topics Working Group.
This year's project is to:
- continually maintain the Nonclinical Study Data Reviewers Guide (nSDRG), based on FDA's Technical Conformance Guide
- provide guidance on "best practices" for creating nSDRG
- compare with anticipated potential requirements for Japanese regulatory submissions (new for 2017)
- 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
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.
|Susan DeHaven||Co-Lead, pharma||Sanofiemail@example.com|
|Debra.Oetzman||Co-Lead, software vendor||Instemfirstname.lastname@example.org|
|Cathy Roy||Team member||Merckemail@example.com|
|Daniel Potenta||Team member||PDS Lifesciencesfirstname.lastname@example.org|
|Linda Hunt||Team member||Merckemail@example.com|
|Nicola Robertson||Team member||GSKfirstname.lastname@example.org|
|Jennifer Feldmann||Team member||Instememail@example.com|
|Patricia Brundage||Team member||FDAfirstname.lastname@example.org|
|Paul Brown||Team member||US FDAemail@example.com|
|Rick Thompson||Team member||J&J||RThompso@its.jnj.com|
|Steve Polley||Team member||GSKfirstname.lastname@example.org|
|Susie Lendal Antvorskov||Team member||Data Standards Decisionsemail@example.com|
|Tania Strimple||Team member||Covance||tania.strimple@Covance.com|
|William Houser||Team member||BMSfirstname.lastname@example.org|
- Implement the visioning process agree upon with PhUSE
- Review and adapt as needed, comments provided by FDA from 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
- Biweekly meetings are now held to work through template and guidance development
Next SDRG package
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
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.
Nonclinical SDRG Template and Guide - Working Drafts
Review Comments Tracker
2015 PhUSE Public Review: Nonclinical SDRG Template and Guide - Drafts for Public PhUSE Review