A1. Cover letter to review committee and competent authority

The cover letter must clearly state to which MREC and/or competent authority the research file is submitted and which documents the submission contains (including version numbers and/or dates).

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.