Research Roadmap

Participation as a Sponsor

When a site participates in a study, the sponsor must provide several documents for the submission file, including:

• A signed Research Decleration or Site Suitability Declaration (in Dutch: Verklaring Geschiktheid Onderzoeksinstelling, VGO);
• The resume of the local investigator, including proof of BROK or GCP training.

For research with a medicinal product (and related amendments) submitted on or after 1 November 2021, the use of the VGO is mandatory. This requirement is established in CCMO’s directive on the assessment of the suitability of research centres (TGO).
For other research falling under the WMO or EU regulations on medical devices (MDR), medical devices for in vitro diagnostics (IVDR), and research with a medicinal product submitted before 1 November 2021, the CCMO’s external review directiveremains applicable. For these studies, a Research Declaration is still accepted. Use of the VGO is voluntary, but its mandatory implementation will be phased in over time.

Participation as participating centre

To conduct WMO research in Amsterdam UMC that has been approved by an external review committee, the Executive Board (EB) has to provide authorisation for local feasibility. If Amsterdam UMC is the sponsor of the study, the process for authorisation is automatically started via the local Medical Research Ethics Committee (MREC). However, you will always receive a separate authorisation letter from the EB.
More information on the procedure to follow can be found on the MREC Amsterdam UMC website

Additionally

For research involving medicinal products, the European Clinical Trial Regulation (ECTR) applies. Before the medical ethical review process, the EB must issue a statement of local feasibility. This statement, known as the VGO, is required for the submission file in CTIS. By signing the VGO, the EB declares that the researcher(s) and the institution have sufficient expertise and facilities to conduct the study.

The following procedure applies to Amsterdam UMC:

1. The principal investigator (or delegate) completes the VGO Appendices in consultation with all supporting departments involved in the study (e.g. Pharmacy);
2. The VGO Appendices are signed by the heads of the supporting departments using the form Declaration of Intent for the Purpose of VGO;
3. The head of the department where the study is conducted signs the first page of the VGO on behalf of the EB. This can be done on paper or electronically (e.g. via Docusign);
4. The signed VGO (first page only, not the appendices) is uploaded to CTIS as part of the submission process;
5. When the study receives a positive opinion from the primary review committee via CTIS, it must be submitted to the MREC of Amsterdam UMC to initiate the procedure for local feasibility and obtain authorisation from the EB. This procedure requires that a fully completed VGO is uploaded in Research Manager. This includes: the first page signed by the head of the department, the appendices, and the Declaration of Intent for the Purpose of VGO.

For more information, visit the MREC Amsterdam UMC website.

For non-WMO research approved by an accredited external review committee, a specific procedure applies. Detailed information can be found on the websites of the MREC Amsterdam UMC and Privacy Protection and Information Security.