I2. Site Suitability Declaration (VGO) or Research Declaration

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 for research with a medicinal product submitted before 1 November 2021, CCMO’s external review directive is applicable. Use of the VGO is not yet obligatory for these types of research, and a Research Declaration may be used instead.

Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO)

The VGO and the procedure for local feasibility have been developed jointly by the Dutch Clinical Research Foundation (DCRF) with its affiliated partners and CCMO. More information can be found on the DCRF-website.

To assess the suitability of research with a medicinal product to be carried out, you are required to submit a VGO of each participating centre to the review committee (accredited MREC or CCMO). This also applies to monocentre research. By signing the VGO, the executive board/management declares that its research centre is suitable to conduct the intended study. More information can be found in DCRF's procedure for local feasibility.

The DCRF has also developed an instruction sheet that briefly outlines the steps you need to follow to obtain a VGO and start the study at the relevant research centre. As indicated in the instruction sheet, submission to the reviewing committee runs parallel to making arrangements around local feasibility.

The VGO is available in Dutch and in English. Institutions may decide for themselves whether to use the Dutch or the English version.

Research contract accompanying VGO

If you submit a signed VGO, you must submit a Clinical Trial Agreement (CTA) in accordance with the VGO procedure. This standard agreement contains a paragraph stating that if the agreement is signed by the executive board/management before the review committee has approved the research, the executive board/management gives the researcher permission, subject to conditions precedent, to conduct the research in the centre. Templates for the CTA are available for industry-sponsored research and for investigator-initiated research.

If there is no clinical trial agreement, as will often be the case with investigator-initiated monocentre research, permission to start the study has to be obtained separately from the executive board/management.

Research Declaration

The head of the department, the healthcare group manager or a person in a similar position compiles the research declaration. This can be done with the aid of the Research Declaration template. More information can be found in the CCMO External Review Directive 2012  (RET 2012) (in Dutch), the research declaration is part of this directive.

Research contract accompanying Research Declaration

If you submit a Research Declaration, you must submit a Clinical Trial Agreement (CTA) in accordance with the Research Declaration procedure. Templates for the CTA are available for industry-sponsored research and for investigator-initiated research.

In most research facilities, permission to start the study has to be obtained separately from the executive board/management.