I2. Site Suitability Declaration (VGO) or Research Declaration

The Site Suitability Declaration [Verklaring Geschiktheid Onderzoeksinstelling, VGO] or Research Declaration is a declaration which supports the review committee (accredited MREC or CCMO) in assessing the suitability of a Dutch (research) centre to carry out medical research. On the basis of the VGO or the Research Declaration the review committee can make a weighted assessment.

Please note! As of 1 November 2021, use of the VGO is obligatory for all newly submitted research with a medicinal product and their amendments. From then on, it will no longer be allowed to use the current Research Declaration for these studies. However, this is still allowed for research with a medicinal product submitted before 1 November 2021.

For other research without a medicinal product subject to the Dutch Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO], the EU Medical Devices Regulation (MDR) or the EU In Vitro Diagnostics Regulation (IVDR), the obligation to use the VGO will be phased in in 2022. However, until then it is possible to use the VGO voluntarily for such research.

The VGO is part of the new procedure for local feasibility which has been developed by the Dutch Clinical Research Foundation (DCRF) together with its affiliated partners and CCMO. More information (in Dutch) is available here.

Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO)

Please note! 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 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.

By signing part A of the VGO, the executive board/management declares that its research centre is suitable to conduct the intended study. The signed part A is based on the information in part B (including annexes) of the VGO or an equivalent of part B. More information on part A and part B can be found in DCRF's procedure for local feasibility.

To assess the suitability of the research to be carried out, you are required to submit a signed part A of the VGO of each participating centre to the review committee (accredited MREC or CCMO). This also applies to monocentre research.

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

If you submit a signed part A of the 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.

A study may only start after a positive decision by the review committee and if the clinical trial agreement has been signed. If there is no clinical trial agreement, as will often be the case with 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 (RET 2012) (in Dutch), the research declaration is part of this directive.

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.