A1. Cover letter

The cover letter should clearly state which review committee (accredited MREC or CCMO) you are submitting the research file or amendment to, or, in the case of clinical investigations within the framework of conformity assessment (MDR article 62 or article 74.2), which review committee you prefer to assess the research file or amendment. If you do not indicate a preference, CCMO will determine which accredited METC will assess your investigation.

You are also required to indicate clearly which documents (including version number and/or date) you are submitting in the research file.

The submitting party is obliged to sign the cover letter. The submitting party may be either the sponsor or someone authorised on behalf of the sponsor.