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 phase in which case the review can take up to 3 months. For further information please consult the CTCG Best Practice Guide for sponsors of multinational clinical trials and the Clinical Trial Advisory Group’s Guidance for the transition of clinical trials
In this document the regular timelines are described: CTIS evaluation timelines
The EMA offers free online CTIS training:
UMCG researchers may contact the SDCRO and/or de Clinical Trial Hub (Research Support Departments – Home (sharepoint.com) for information, CTIS access, or help with preparing the submission of a transition trial.