Site Suitability Declaration (VGO)

  • WMO

      During the study preparation phase, a sponsor selects suitable research sites to conduct the study. A key component of this process in the Netherlands is a statement known as the Site Suitability Declaration (in Dutch: Verklaring Geschiktheid Onderzoeksinstelling, VGO).

      Purpose and structure of the VGO

      The VGO is a nationally developed statement that supports the review committee in assessing the suitability of a Dutch site to conduct medical-scientific research.

      The VGO consists of the VGO form and appendices. The appendices contain general study information and list the necessary study procedures and agreements for each supporting department. The sponsor provides a pre-filled, site-specific VGO, which is completed by the researcher and supporting departments to confirm that they have been informed about the study and are able to conduct it according to the study protocol. By signing the VGO form, the Executive Board or management confirms that the study staff and institution have the necessary expertise and facilities to conduct the study, thereby establishing the suitability of the site.

      It is important to note that the VGO is linked to a conditional clause in the Clinical Trial Agreement (CTA) and the approval letter from a review committee. Together, these three documents form the legal basis for starting a study at a research site. A site can still choose to withdraw after signing the VGO.

      For the VGO template, an instruction sheet and further details, visit the DCRF website.

      VGO at Amsterdam UMC

      Starting 1 March 2025, a VGO is mandatory for all WMO research conducted at Amsterdam UMC. This includes research subject to the CTR (as established in CCMO’s directive on the assessment of the suitability of research centres (TGO)), as well as other research subject to the WMO, MDR and IVDR.

      To obtain a signed VGO for studies where Amsterdam UMC is either the sponsor or a participating site, follow these steps:

      1. The principal investigator (or delegate) completes the VGO, including appendices, in consultation with all supporting departments involved in the study (e.g. pharmacy, laboratory, radiology);
      2. The heads of the supporting departments sign the Declaration of Intent for the Purpose of VGO, providing preliminary approval based on the VGO appendices;
      3. Based on the signed Declaratations of Intent, the head of the leading department where the study will be conducted signs the first page of the VGO form on behalf of the Executive Board. This can be done on paper or electronically (e.g. via Docusign);
      4. The signed VGO (first page only, not the appendices) is sent to the sponsor and included in the standard research file for submission to the review committee. For more information, see Step 3: Submitting & review procedure.