Management of ODS Regulatory Referenced Deliverables

Project Description

Project Description

This project establishes a structured process to maintain PHUSE regulatory referenced deliverables by appointing primary and back-up representatives for each. These representatives will ensure alignment with evolving regulatory guidance by reviewing updates, identifying required changes, coordinating feedback, and overseeing revisions and publication.

The Optimizing the Use of Data Standards Working Group maintains key deliverables, including the cSDRG, ADRG, SDSP and BDRG, with additional outputs planned. Currently, no formal maintenance process exists, and original project teams no longer meet regularly, creating a risk of misalignment with regulatory guidance.

This project introduces a sustainable, scalable approach to ongoing maintenance, ensuring deliverables remain current, consistent and aligned with regulatory expectations. Updated templates, examples and guidance will continue to support sponsors in meeting FDA and other regulatory requirements.

Project Leads	Email

Project Leads	Email
Janet Low, Merk	janet_low@merck.com
Christine Rossin, Pfizer	Christine.Rossin@pfizer.com
Alex Pearce, PHUSE Project Coordinator	alexandra@phuse.global