A timely transition to CTR of investigator initiated trials with medicinal product is important. This can only be done thru the online submission portal CTIS. Clinical trials with medicinal products that have at least one active site on the 30th of January 2025 must be transitioned to CTR. Trials that are not yet approved according to CTR loose their previous approval and will be terminated per 31st January 2025.
Recently, the CTCG (Clinical Trial Coordination Group) has published a Best Practise document for sponsors which describes how to prepare for a multinational trial with different versions of the research protocol.
This document can be found here: Best Practice Guide.
There’s an accompanying Cover letter template. That document can be found here: cover letter template.