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 other medical research. Some of the documents only have to be submitted when applicable.
Please note! As of 31 January 2022, a new EU-regulation on research with a medicinal product (Clinical Trial Regulation, CTR) has come into force, supplanting the prior WMO Act on research with a medicinal product. For new research under CTR, a separate standard research file is available: Clinical trials with medicinal products (CTR). For ongoing research with a medicinal product subject to the WMO Act, a document is available with frequently asked questions about EudraCT and CTR.
Separate standard research files are also available for clinical investigations with medical devices and performance studies using in vitro diagnostics.
A document is available with an overview of and explanatory notes on the complete research file.
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.
Submit the documents preferably in the indicated order. 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.
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.
The Medical Research Involving Human Subjects Act (WMO) and the Regulation scientific research with medicinal products form the basis for the standard research file.