Nonclinical Study Data Reviewers Guide
- 1 Current Work - Summer 2019
- 2 Purpose
- 3 Overview and Scope
- 4 Current Published nSDRG Package
- 5 Project Team
- 6 Plans
- 7 Next Meeting
- 8 Presentations
- 9 Call for Members
- 10 Working Documents
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
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 - Summer 2019
Improving Section 5. Data Standards Validation Rules, Versions, and Conformance Issues
FDA Reviewers have given feedback on questions from the nSDRG team. Click Here to read the questions and answers: nSDRG Section 5 Q&A with FDA
Identifying Location of Study Endpoints in SEND Datasets
FDA has asked the nsdrg team about ways to help reviewers identify the location of the endpoints found in the study report in the SEND datasets. The nsdrg team is currently brainstorming for efficient ways to address this need, considering impact on sections 4.1 and 6.2.
nsdrg in XML as a future format?
The Optimizing the Use of Data Standards working group has a project developing the csdrg and adrg in .xml format: Data Reviewer Guide in XML. Mike Hamidi, a co-lead on this project presented their work and the possibility to do same for nsdrg in mid 2020. The nsdrg team is considering the opportunities, impacts and benefits of developing a nonclinical deliverable.
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
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|
|Anja Metzger||Team member||Bayeremail@example.com|
|Brett Coupland||Team member||Astrazenecafirstname.lastname@example.org|
|Cathy Roy||Team member||Merckemail@example.com|
|Daniel Potenta||Team member||PDS Lifesciencesfirstname.lastname@example.org|
|Christy Kubin||Team member||MPI Researchemail@example.com|
|Florence Halbert||Team member||Novartisfirstname.lastname@example.org|
|Gitte Frausing||Team member||Data Standards Decisionsemail@example.com|
|Haley Wulff||Team member||Basincfirstname.lastname@example.org|
|Hepei Chen||Team member||FDAemail@example.com|
|Laura Kaufman||Team member||Eagleusfirstname.lastname@example.org|
|Linda Hunt||Team member||Merckemail@example.com|
|Lindsy Eickhoff||Team member||Basincfirstname.lastname@example.org|
|Matthew Whittaker||Team member||FDAemail@example.com|
|Mark Carfagna||Team member||Lillyfirstname.lastname@example.org|
|Michael Rosentreter||Team member||Bayeremail@example.com|
|Maureen Rossi||Team firstname.lastname@example.org|
|Nicola Robertson||Team member||GSKemail@example.com|
|Jack Baker||Team member||Covance||Jack.Baker@covance.com|
|Jennifer Abbott||Team member||Abbviefirstname.lastname@example.org|
|Jennifer Feldmann||Team member||Epredaemail@example.com|
|Patricia Brundage||Team member||FDAfirstname.lastname@example.org|
|Paul Brown||Team member||US FDAemail@example.com|
|Rick Thompson||Team member||J&Jfirstname.lastname@example.org|
|Steve Polley||Team member||GSKemail@example.com|
|Susie Lendal Antvorskov||Team member||Data Standards Decisionsfirstname.lastname@example.org|
|Tania Smith||Team member||Covance||tania.strimple@Covance.com|
|William Houser||Team member||BMSemail@example.com|
- 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
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.
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 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