This project is to evolve the Nonclinical Study Data Reviewer's Guide (nSDRG), based on comments from a public PHUSE review, plus to adapt it to updates of the FDA Technical Conformance Guide. The project continues to check and align with the SDRG template and guide developed by the Optimizing the Use of Data Standards Working Group for clinical studies.
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 operationalise this new documentation requirement efficiently and effectively.
Challenges we seek to answer with this project:
Things we expect to learn along the way:
|Objectives and Deliverables||Timelines|
|Maintain the Nonclinical SDRG based on FDA's TCG and any public feedback||Q2 2021|
Team review of next template and guide completed, and proposed updates agreed.
Release for concurrent public review and FDA review in August.
|nSDRG Package||Version 1.1, 17-Mar-2017|
|Maintaining the Clinical & Nonclinical Study Data Reviewers Guides||CSS 2018 Workshop|
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. 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.
|PDS Life Sciences|
|PointCross Life Sciences|
|Gitte Frausing||Data Standards Decisions|
|Bristol Myers Squibb|
|Rick Thompson||Janssen Research & Development|
|Susie Lendal Antvorskov||Data Standards Decisions|
|William Houser||Bristol Myers Squib|