Research Roadmap

Participate as sponsor

When a site participates, the sponsor needs a number of documents for the submission file, including:

• Signed Research Decleration or Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO)
• Resume of the local investigator including BROK or GCP training

For research with a medicinal product (and the related amendments) submitted on or after 1 November 2021, use of the VGO is obligatory. This obligation is laid down in CCMO’s directive on the assessment of the suitability of research centres (TGO). For other research within the scope of WMO or EU-regulations on medical devices (MDR) and medical devices for in vitro diagnostics (IVDR) and research with a medicinal product submitted before 1 November 2021, CCMO’s external review directive remains applicable, to which a Research Declaration applies. Use of the VGO for these studies is voluntary. The obligation to use the VGO for these studies will be phased in.

Participate as participating centre

To conduct WMO research in AmsterdamUMC that is approved by an external review committee the Executive Board (EB) has to review local feasibility. If Amsterdam UMC is the sponsor of the trial such approval is applied for automatically via the local medical ethical review committee (MREC). You will always receive a separate authorisation letter from the EB.

You can find the specific procedure to be followed on the website of our local MREC

 Additions:

- For research involving medicinal products the ECTR regulatory is applicable. The EB must issue the statement of local feasibility prior to the medical ethical review process. This statement, called VGO (Verklaring Geschiktheid Onderzoeksinstelling), is part of the submission file in CTIS. By signing Part A of the VGO, the Executive Board declares that the researcher(s) and the institution have sufficient expertise and facilities to carry out the research.

For further details and local procedures see the CMC site and the Research Manager manual for researchers VGO + local feasibility

- For non-WMO research that was approved by an accredited external review committee a specific procedure applies which you can find on the websites of our local MREC. Registration of these non-WMO studies will be managed through Research Manager.