Project Scope

Develop a Data Reviewer’s Guide Template (referenced in the Technical Conformance Guide) and associated documents to allow up front communications regarding the sponsors interpretation of the Bio-research Monitoring Technical Conformance Guide. Initially, the scope will include the development of the template and then expand to cover the full suite of documents. The current cSDRG and ADRG templates will be considered to avoid unnecessary duplication of content. Therefore, revision of these templates are not in scope.

Project LeadsEmail
Julie Maynard (Johnson & Johnson)jmaynar1@its.jnj.com
Sopan Kaith (Cytel)sopan.kaith@cytel.com
Katie Warren

(PHUSE Project Assistant)

katie@phuse.global

Objectives & DeliverablesTimelines

Finalisation of full BDRG package (assessing/incorporating comments from public review): 

Q2 2022
Publication of BDRG Q2 2022

CURRENT STATUS Q2/3 2022

  • Published BDRG Package 
  • Submitted New Project Request which is currently pending approval: Bioresearch Monitoring (BIMO) Frequently Asked Questions Forum
  • Project currently on hold until Q4 2022 
Project MembersOrganisation
Aatiya ZaidiGilead
Adity ShelkePfizer
Amie SagadyTakeda
Aohra MonceauxSanofi
Avinash Reddi PattiGSK
Barbara LockleyIndustry
Bhanu KannanFDA
Bei YuFDA
Cara AlfaroFDA
Cathy MichalskyTeva Pharmaceuticals
Chunying YinJanssen Research & Development
Cynthia KleppingerFDA
David Postma Pfizer 
Dmitry GolubovskyTeva Pharmaceuticals
Gabriela LopezMitnik FDA
Harini KunduruDSI
Karen BleichFDA
Kathryn KnucklesEli Lilly
Ke WangBristol Myers Squibb
Kiran KundarapuMerck
Kirsty WallGSK
Jack FieldAstraZeneca
Jasmin Jobanputra Novonordisk
Jean Mulinde FDA
Lin YuanAstellas 
Project MembersOrganisation
Lisa ZhouJanssen Research & Development
Maggie LoLung Biotechnology PBC
Michael JohnsonFDA
Meng LiAstraZeneca
Nancy BauerBoehringer Ingelheim
Nigel MontgomeryRoche
Phil LiuAstraZeneca
Phyllis SmetanaUCB
Sai MaBayer
Satheesh AvvaruPPD
Santosh Kumar LingalaGilead
Shreetam SheregarLabcorp
Srinivasan RamasubramanianAbbVie
Stanley AuFDA
Stanley BrillJanssen Research & Development
Steve FitzpatrickNovartis
Steven ClarkAstellas
Todd RiderBristol Myers Squibb
Yan (Joy) Shen Pfizer

Problem Statement

FDA drafted the initial Bio-research Monitoring Technical Conformance Guide in December 2017, with an updated version published in July 2020 (https://www.fda.gov/media/85061/download). The guide provides specifications for preparing and submitting the following components in electronic format that are used by FDA for planning of Bio-research Monitoring (BIMO) inspections.

  • Clinical Study-Level Information.
  • Subject-Level Data Line Listings by Clinical Site.
  • Summary-Level Clinical Site Dataset (clinsite.xpt).

NDA, BLA, and supplemental submissions to FDA require BIMO as a critical part of the electronic application.

There is currently a lack of clarity as each sponsor will have defined their own approach to the generation of this content, especially where there is a need to interpret the Technical Conformance Guide. 

Problem Impact

This need for interpretation leads to inconsistencies between Sponsors when submitting this content to the agency.  Potentially, this results in the need for Sponsors to provide additional clarification to the agency subsequent to the submission of the content.

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