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Project Scope |
To discuss and focus on a robust strategy/process and best practises for - Identifying critical items
- Risk Based data review approaches
- Risk Based Monitoring approach strategy (tSDV/tSDR)
- Usage of analytical tools and methods for data review & central monitoring, including limitations on (statistical) methodologies
- Identification of thresholds or equivalent on limited patient data
- Targeted medical review
- Strategy to adequately anticipate on highly dynamic dataEstablish links with the other work streams on FIH/small studies focus
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- New project approved currently calling for volunteers
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| Objectives | Timelines |
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| Present at the PHUSE Connect | Q1 2025 |
White paper or guidance document with a mutually agreed process for RBQM on FIH/small studies | Q2 2025 |
