A1. Cover letter to review committee and competent authority

The cover letter must clearly state to which MREC the research file is submitted and which documents the submission contains (including version numbers and/or dates). For amendments of ongoing research subject to the Dutch WMO Act, a template coverletter to the competent authority is provided below.

In addition we recommend to describe the status of the study (number of included patients, completed phases/cohorts) when submitting multicenter studies in which the Netherlands does not participate in all phases of the study and to indicate which group(s) of study subjects (adults/children, patients/healthy volunteers) will be included in the Netherlands.

The cover letter must be signed by the submitting party. If the submitting party is the project leader/coordinating investigator/head of department, it is recommended that the cover letter be co-signed by one of these persons.