№ lp_1_2_47803
The document provides guidance for structuring supplementary information to be included in a Clinical Trial Regulation (CTR) cover letter, specifically for platform trials and complex clinical trial designs.
Year: 2023
Region / City: EU
Topic: Clinical trial regulations, platform trial design
Document type: Guidance
Organization / Institution: EU-PEARL consortium, ECRIN
Author: Sal Morello, Siard Houtzager, Cecile Spiertz, Sabina Hernandez Penna, Peter Mesenbrink, Tom Parke, Franz Koenig, Benjamin Hofner, Katharina Hees
Target audience: Regulatory agencies, clinical trial sponsors
Period of validity: April 2023
Approval date: April 2023
Date of changes: Not applicable
Price: 8 / 10 USD
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