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 the VGO, the Executive Board declares that the researcher(s) and the institution have sufficient expertise and facilities to carry out the research.

The procedure described below applies to Amsterdam UMC:

1. the principal investigator (or delegate) completes - in consultation with all supporting departments involved in the study (e.g. Pharmacy) - the (paper) form VGO Appendices and has it signed by the heads of the supporting departments using the form 'declaration of intent for the purpose of VGO' '.
2. The head of the department where the study is being conducted signs the VGO (only the first page) on behalf of the Executive Board. This can be done on paper or, for example, via Docusign.
3. The signed VGO (only the first page mentioned in 2., not the appendices) is uploaded to CTIS for submission.
4. When the study has received a positive opinion from the primary review committee via CTIS, the study must be submitted to the MREC of Amsterdam UMC to further initiate the procedure for local feasibility and to obtain approval from the Executive Board. This procedure requires a fully completed VGO (includes first page with a signature of the head of department, appendices and the decleration of intent for the purpose of VGO) which is uploaded in Research Manager and is conditional to obtain local feasibility.

More information about this procedure can be found on the website of the MREC Amsterdam UMC.

- 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.