Standard research file (WMO)
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 for research with a medicinal product subject to the Dutch WMO Act and medical research subject to the Dutch Embryo Act. Some of the documents only have to be submitted when applicable.
Attention! Separate standard research files are available for clinical trials with medicinal products (CTR), clinical investigations with medical devices and performance studies using in vitro diagnostics.
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, additional documents may be required that are not listed in the standard research file. Enquiries can be made with the accredited MREC concerned.
The review starts at the moment the submitted research file is complete.
Submission of documents before and after review
The list of documents of the standard research file contains documents required for primary submission.
Resubmission
When resubmitting a research file, the modifications in the submitted documents as compared to the original research file should be clear. This concerns mainly the research protocol and the information letter for the participants, including the consent form.
You are therefore required to submit two versions of each modified document: 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.