A cover letter template is available. This template is mandatory in the Netherlands.
If the clinical trial is submitted in other MSs as well, all additional topics should be taken up in the one cover letter for all MSc. This information is necessary for the assignment by the CCMO to a qualified MREC or to CCMO in case of certain types of clinical trials. The cover letter must also clearly state the proposed MREC in the Netherlands to assess the clinical trial after the research dossier is validated. The CCMO will take notice of the proposed MREC but can assign the clinical trial to another MREC for reasons of legal competence, timelines and expertise.
The cover letter has to be signed. Because of the signature, two copies must be uploaded in CTIS: first the copy without the signature “for publication”, followed by the copy with the signature “not for publication”.