Submitting a complete and well-structured research file
If your research falls within the scope of the WMO (see the first theme of this online course Explaining the Dutch Review System) then you must submit a research file for review to the reviewing committee (an accredited MREC or in special cases the CCMO). In the current theme we will explain which documents you need to submit to the reviewing committee in order to allow an adequate and efficient review to be carried out.
We will also address how you need to organize your research file using the predefined sections for the various documents. This may sound rather bureaucratic, and it is, but it also helps you to compile a complete research file.
Submitting a standardized research file will limit the process time at the reviewing committee´s office. In addition, the standardization of the research file allows the reviewing committee to efficiently navigate in the file. An incomplete research file will result in unnecessary delays in the review.
"An incomplete research file will result in unnecessary delays in the review"
Standardized format
At the CCMO
website you can find an outline of the standard research file which provides a standard format and an overview of the required documents and information. Most of the documents are required for all types of clinical research. For some studies additonal documents are required, such as the EudraCT documents when you apply for approval for a clinial trial with medicinal products.
Sections in the research file The standard research file contains of sections A upto M. Each section of your research file will contain specific documents. As an example: section A will contain the cover letter and all other correspondence with the reviewing committee. The various forms (e.g., ABR-form, EudraCT-forms) are included in section B, the research protocol in section C, product or device information in section D, information for research subject including the informed consent form in section E, etc.
The last two sections of the research file i.e., section L and section M are not included in the primary submission of your research file. These two sections become relevant when your research file is approved and the trial is ongoing.
Hard copy or digital submission
Depending on the reviewing committee you can submit a hard copy or digital research file. Check this with the committee that will review your application. For the CCMO and most of the accredited MRECs the preferred method of submission is a digital research file on cd-rom, USB-stick or on a digital platform.
If you choose for digital submission at the MREC or CCMO, you still need to submit all documents in pdf format and using file names with the predefined codes and classification as indicated at the CCMO website in the document Codes and document titles for digital submission.
Clinical trials with medicinal products
For studies in which a medicinal product is investigated, the review of the complete research file including the Investigator’s Brochure (IB) and Investigational Medical Product Dossier (IMPD) is done by an accredited MREC or in special cases the CCMO. In addition, the research file must also be submitted to the competent authority that will perform a marginal review.
When the review is done by an accredited MREC, the CCMO is the competent authority. In the special cases where the CCMO is the reviewing committee, the Medicines Evaluation Board (MEB) is the competent authority in behalf of the Minister of Health, Welfare and Sport.
Information on submission to competent authority can be found on the CCMO website. Use the Committee Finder (CoF) tool which we introduced in the first theme of this course to find out with committees and other bodies are involved in the review of your research proposal.