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Project Scope

This project is to evolve

the Nonclinical

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:

  • 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?



Project Leads

Email

Sue Dehaven

susan.dehaven@sanofi.com

Debra Oetzman, Instem

debra.oetzman@instem.com

Key Milestones 

Sue DeHaven, Sanofi

susan.dehaven@sanofi.com

Alex Pearce, PHUSE Project Assistant

Alexandra@phuse.global

ObjectiveTimelinePrioritised list of domains/variables required for harmonisationQ3 2020 Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as neededQ2 2021Poster presentation and update of current working group progress at CSSQ2 2021 PHUSE Publication or white paperQ2 2021


Status
colourBlue
titleCurrent Status

ResourcesVehicle Components SurveyDraft White Paper SEND Package ASEND Package BSEND Package CSEND Package D

Project Members 

Organisation Anja MetzgerBayer

Brett Coupland

Astrazeneca

Cathy Roy

Merck

Christy Kubin 

MPI Research

Daniel Potenta 

PDS Lifesciences

Debra Oetzman

Instem

Deepika V.G 

Point CrossFlorence Halbert NovartisGitte Frausing Data Standards DecisionsHepei Chen FDAJack Baker CovanceJennifer Abbott AbbvieJennifer Feldmann EpredaKaren Porter Point CrossKenneth Hershman Novartis

Q1 2024

  • Currently investigating discrepancy discovered in nSDRG package v1.2 regarding Section 1.3, to determine if a minor version issue is warranted.   



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.



Published Deliverables

nSDRG v1.2 

Version 1.2, 8 April 2022
Maintaining the Clinical & Nonclinical Study Data Reviewers Guides CSS 2018 Workshop

Project Members 

Organisation 

Linda Hunt 

Merck

Lindsy Eickhoff 

Basinc

Mandie Rhodes 

BMS

Mark Carfagna 

Eli LillyMatthew WhittakerFDAMaureen Rossi RocheMichael Rosentreter BayerNicola Robertson GSKPatricia Brundage FDAPaul Brown FDARick Thompson J&JSenthil Palani XybionSteve PolleyGSKSusie Lendal Antvorskov Data Standards DecisionsTania Smith CovanceWilliam Houser BMS