Transition to CTR
EMA has published a document to help Sponsors / Investigators with the transition of drug trials: CTIS: how to get started and how to transition a trial. The review of a transition trial in the Netherlands is free of charge. An expedited procedure is possible except in cases where questions are raised in the validation […]
Best Practise for multinational transition trials
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 […]
31 January 2023 CTR applicable for new trials with medicinal products
On 31 January 2023, the EU Clinical Trial Regulation (CTR) will be applicable for new clinical trials with a medicinal product. The CTR became applicable as of 31 Januari 2022. A transition period of three years started. During the first year, sponsors can choose to submit a clinical trial application according to the current legislation, […]