5/4/2023 0 Comments Declaration pageTemplates for the CTA are available for industry-sponsored research and for investigator-initiated research. 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. If you submit a signed VGO, you must submit a Clinical Trial Agreement (CTA) in accordance with the VGO procedure. As indicated in the instruction sheet, submission to the reviewing committee runs parallel to making arrangements around local feasibility.ĭownload the Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO) (English) Research contract accompanying VGO 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. More information can be found in DCRF's procedure for local feasibility. By signing the VGO, the executive board/management declares that its research centre is suitable to conduct the intended study. This also applies to monocentre research. 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). More information can be found on the DCRF-website. 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. Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO) Use of the VGO for these studies is voluntary for the time being. For other research within the scope of WMO or EU-regulations on medical devices (MDR) and medical devices for in vitro diagnostics (IVDR) and research with a medicinal product submitted before 1 November 2021, CCMO’s external review directive is applicable, to which a Research Declaration applies. This obligation is laid down in CCMO’s directive on the assessment of the suitability of research centres (TGO). The Site Suitability Declaration 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.įor research with a medicinal product (and the related amendments) submitted on or after 1 November 2021, use of the VGO is obligatory.
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