Work Package 5
Work Package 5: Regulatory Issues, Standards, and Quality Assurance
Work Package 5 aims to
- develop the required regulatory documents for clinical studies of fluoro-L-thymidine (FLT) and ICMT-11 for use in multicenter trials;
- work with other centers to produce the required documentation for their specific countries;
- produce template documents in English for investigational Medicinal Prodact Dossier (IMPD), Investigator Brochure, Ethics proposal and Patient information sheets.
Participating QuIC-ConCePT partners:
- Guys and St. Thomas NHS Trust, United Kingdom
- F. Hoffmann-La Roche AG, Switzerland
QuIC-ConCePT