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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 Maynardjmaynar1@its.jnj.com
Sopan Kaithsopan.kaith@tcs.com
Paula Rowley 

(PHUSE Project Assistant)

paula@phuse.global 

Objectives & DeliverablesTimelines
Kick Off ProjectApr-2021
Template & Completion GuidelinesOct-2021
ExamplesDec-2021

CURRENT STATUS Q3/42021

  • Sub-teams and Leads to evaluate and incorporate the PHUSE CSS feedback into the Draft Template and Completion Guidelines. 
  • Sub-teams and Leads to finalise the Examples and full team review of the BDRG Package to be completed on 19th November 2021. 
  • BDRG Package to be sent to the PHUSE Steering Committee for review on 22nd November 2021.
  • PHUSE BIMO team review of comments and any updates to documents.  
  • Public review projected for 15th December 2021 to 31st January 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
Harini KunduruDSI
Karen BleichFDA
Kathryn KnucklesEli Lilly
Ke WangBristol Myers Squibb
Kiran KundarapuMerck
Kirsty WallGSK
Jack FieldAstraZeneca
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
Jasmin JobanputraNovonordisk


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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