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 to submit a signed declaration suitability investigational site [Verklaring Geschiktheid Onderzoeksinstelling, VGO, deel A].

Clinical Trial Agreement

If a signed part A of the VGO is submitted, the Clinical Trial Agreement (CTA) in accordance with the VGO procedure should be used by the sponsor and the investigational site. 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.