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. |
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. |
Project Leads | Email |
Julie Maynard |
(Johnson ) ()Paula Rowley (Nicola Newton, PHUSE Project Assistant |
)paula@phuse Objectives & Deliverables | Timelines |
Publication of BDRG v3.0 | Q2 2023 |
Presentation of BDRG v.30 in PHUSE June Webinar WednesdayQ2 2023 | Published Deliverables
Status |
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colour | Blue |
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title | Current Status |
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Q1 2023Incorporating PHUSE Steering Committee feedback into BDRG v3.0 |
Todd Rider | Bristol Myers Squibb |
Yan (Joy) Shen | Pfizer |
- Leads of this project will meet with key players to identify if there is any need for major updates in the near future
- Project will now move to the Management of ODS Regulatory Referenced Deliverables Working Group project
- Project to close
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Project Members | Organisation |
Aatiya Zaidi | Gilead |
Adity Shelke | Pfizer |
Amie Sagady | Takeda |
Aohra Monceaux | Sanofi |
Avinash Reddi Patti | GSK |
Barbara Lockley | Industry |
Bhanu Kannan | FDA |
Bei Yu | FDA |
Cara Alfaro | FDA |
Cathy Michalsky | Teva Pharmaceuticals |
Chunying Yin | Janssen Research & Development |
Cynthia Kleppinger | FDA |
David Postma | Pfizer |
Dmitry Golubovsky | Teva Pharmaceuticals |
Gabriela LopezMitnik | FDA |
Harini Kunduru | DSI |
Karen Bleich | FDA |
Kathryn Knuckles | Eli Lilly |
Ke Wang | Bristol Myers Squibb |
Kiran Kundarapu | Merck |
Kirsty Wall | GSK |
Jack Field | AstraZeneca |
Jasmin Jobanputra | Novonordisk |
Jean Mulinde | FDA |
Lin Yuan | Astellas |
Project Members | Organisation |
Lisa Zhou | Janssen Research & Development |
Maggie Lo | Lung Biotechnology PBC |
Michael Johnson | FDA |
Meng Li | AstraZeneca |
Nancy Bauer | Boehringer Ingelheim |
Nigel Montgomery | Roche |
Phil Liu | AstraZeneca |
Phyllis Smetana | UCB |
Rashed Hasan | FDA |
Sai Ma | Bayer |
Santosh Kumar Lingala | Gilead |
Saritha Bathi | Bristol Myers Squibb |
Satheesh Avvaru | PPD |
Shreetam Sheregar | Labcorp |
Sowmya Gabbula | IQVIA |
Srinivasan Ramasubramanian | AbbVie |
Stanley Au | FDA |
Stanley Brill | Janssen Research & Development |
Steve Fitzpatrick | Novartis |
Steven Clark | Astellas |
Bio-research Monitoring Data Reviewers Guide (BDRG) | Version 1.0, 05 Jan 2020 |
Objectives & Deliverables | Timelines |
Publication of BDRG v3.0 | Q2 2023 |
Presentation of BDRG v.30 in PHUSE June Webinar Wednesday | Q2 2023 |