You are viewing an old version of this page. View the current version.
Compare with Current
View Page History
« Previous
Version 4
Next »
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
|
|
|---|
- New project approved currently calling for volunteers
|
| Objectives | Timelines |
|---|
| Present at Phuse Connect session | Q1 2025 |
White paper or guidance document with a mutual agreed process for RBQM on FIH/Small studies | Q2 2025 |
