I2. Research declaration or Site Suitability Declaration
The Research Declaration or Site Suitability Declaration [Verklaring Geschiktheid Onderzoeksinstelling, VGO] is a declaration of the feasibility of a medical research in a (research) centre in the Netherlands. This declaration supports the review committee (accredited MREC or CCMO) which is designated to assess the practicability of a medical scientific research. On the basis of the Research Declaration or VGO the review committee can make a weighted assessment.
Please note! As of 1 December 2020, sponsors are able to choose either to submit the VGO or the current Research Declaration for the assessment of the suitability of the participating centres. As of 1 November 2021, use of the VGO will become obligatory for research with a medicinal product. From then on, it will no longer be allowed to use the current Research Declaration for research with a medicinal product.
In 2022, the obligation to use the VGO for other research subject to the Dutch Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO] will be phased in. 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.
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. More information can also be found on the page regarding multicenter research.
If you submit a Research Declaration, you must submit a Clinical Trial Agreement (CTA) in accordance with the current procedure. Templates for the CTA are available for industry-sponsored research and for investigator-initiated research.
Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO)
If you wish to make use of the new procedure for local feasibility, you must submit a signed part A of the VGO. The signed part A of the VGO may be based on the information from part B or a comparable alternative to part B. More information on part A and part B of the VGO can be found in the description of the procedure.
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 VGO, you must submit a Clinical Trial Agreement (CTA) in accordance with the new procedure. Templates for the CTA are available for industry-sponsored research and for investigator-initiated research.