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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 Maynard (Johnson & Johnson)jmaynar1@its.jnj.com
Sopan Kaith (Cytel)sopan.kaith@tcskaith@cytel.com
Paula Rowley Katie Warren

(PHUSE Project Assistant)

paula@phusekatie@phuse.global 


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

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

Q2 2022
Publication of BDRG Q2 2022


Status
colourBlue
titleCurrent 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. 

    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 PfizerJasmin 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.