Standard research file

Your research file must include a number of basic documents before you submit it for a primary review to an accredited MREC or CCMO. These are listed below. Some of the documents only have to be submitted when applicable.

Explanatory notes

A document is available with an overview of and explanatory notes on the complete research file.

Additional documents

If an accredited MREC carries out the review then it is possible that additional documents may be required which are not listed in the standard research file. Enquiries can be made to the accredited MREC concerned.

Submission

Submit the documents preferably in the indicated order. The review starts at the moment the submitted research file is complete.

Research with a medicinal product

In the case of research with a medicinal product additional documents are required: these are indicated in each section in this overview.

The research file of a research with a medicinal product which is submitted to the reviewing committee must also be submitted to the competent authority (CCMO or Ministry of Health, Welfare and Sport). For more information see Extra review competent authority research with a medicinal product. The competent authority requires you submit the file digitally.

Submission of documents before and after review

In the list of documents of the standard research file are documents required for primary submission and documents to be submitted to the reviewing committee and the competent authority (if applicable) after a positive decision and/or no grounds for non-acceptance.

Resubmission

When resubmitting a research file, it should be clear what has changed in the submitted documents when compared to the original submitted research file. This concerns mainly the research protocol, the Investigator's Brochure (IB), the Investigational Medicinal Product Dossier (IMPD), the Investigational Medical Device Dossier (IMDD) and the information letter for the subjects including the consent form.

Therefore you should send in two versions of each modified document for resubmission: a version with track changes and a 'clean' version in which the changes in the document have been accepted. If a version with track changes is unreadable due to the many changes, you may send in a detailed overview of the changes instead.

Basis

The Medical Research Involving Human Subjects Act (WMO) and the Regulation scientific research with medicinal products form the basis for the standard research file.