Suitability of the facilities

The CCMO guideline on Review Site Suitability [CCMO-richtlijn Toetsing Geschiktheid Onderzoeksinstelling] is applicable in the Netherlands. This guideline makes it mandatory for research with a medicinal product submitted on or after 1 November 2021 to submit a signed declaration suitability investigational site [Verklaring Geschiktheid Onderzoeksinstelling, VGO].

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 on the VGO 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.

Please note! On 23 February 2023, a new version of the VGO is in use. There is a transition phase until 1 June 2023 during which the old version is still accepted.

Clinical Trial Agreement

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.

Please note that the CTA does not have to be submitted in CTIS.

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.