Submission of clinical trial application

  1. The study must be announced at the official secretariat by telephone first, after which a MREC review date will be assigned in mutual agreement. At the same time the applicant may submit the study to the CCMO, the competent authority (see also www.ccmo.nl). Momentarily a waiting time for assignment applies!
  2. When subsequently the documents – as mentioned in the SOP – are submitted digitally (on CD), as well as on paper, and received by the official secretariat at least eleven working days (2 weeks) before the MREC meeting, the study will be allocated to the agenda of the agreed meeting.
  3. The request for review must include at least the following documents:
    • cover letter with commentary on the protocol/dossier
    • copy of an adequately filled and signed ABR-registration form (after submitting to the CCMO https://www.toetsingonline.nl) as well as a signed EudraCT-form
    • the research protocol, and possible amendments
    • a study synopsis (optional)
    • the Investigator’s Brochure (IB), the Investigational Medicinal Product Dossier (IMPD) and/or any other relevant product information
    • the written information for the human subject in an for him/her understandable language (see SOP)
    • the written consent for the human subject (see SOP)
    • the recruiting documents (e.g. condensed information sheet for subjects, brochure and/or advertisement)
    • information regarding the remuneration for the subject
    • evidence of adequate insurances in conformity with WMO regulations
    • the CV(s) of the investigator(s),¬† signed and dated
    • the signed contract between sponsor and investigator, according to CCMO regulations, and if applicable the signed DSMB Charter
    • the applicant must confirm agreement with the financial consequences of the reviewing of the study by the MREC
  4. The documents, as referred to above, have to be submitted digitally and on paper, to the official secretariat of the MREC. Furthermore an extra copy of the following documents is required: cover letter – ABR form – sections E & F of the dossier. Paper copies of the IMPD should be submitted in consultation with the secretariat; for phase III and IV studies it may be sufficient to submit a summary of the product characteristics.
  5. The official secretariat verifies the completeness of the submitted information as mentioned in the SOP and makes it available to the members of the MREC.
  6. The applicant and/or investigator may be invited to answer questions during the MREC meeting, by teleconference.

Foundation Beoordeling Ethiek Biomedisch Onderzoek