Clinical Integrated Study Data & Analysis Data Reviewer's Guide
Project Description |
This project addresses the limitation that cSDRG and ADRG templates are designed for single studies, while sponsors increasingly use them for integrated study data and analysis. It focuses on adapting these templates to effectively capture and document information across multiple studies. The project will evaluate whether a single integrated reviewer’s guide or two separate guides (for integrated study data and integrated analysis data) provides the most effective approach. The aim is to ensure clarity, consistency and usability for regulators reviewing integrated submissions. Key deliverables include a standardised template, comprehensive completion guidelines, and example documents to demonstrate best practice. These outputs will support sponsors in producing clear, consistent and fit-for-purpose reviewer’s guides for integrated datasets, improving review efficiency and submission quality. |
Project Leads | |
|---|---|
Kiran Kundarapu, Lilly | |
Satheesh Avvaru, Alexion | |
Randi McFarland, Ephicacy | |
Alex Pearce, PHUSE Project Coordinator |
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