From 1 December 2020 modified procedure for submitting local feasibility declaration
From 1 December 2020, the procedure for submitting a declaration of local feasibility for medical research will be modified. In the new procedure, the current Research Declaration has been replaced by the Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO). To switch from the current procedure to new procedure a transitional period from December 1, 2020 till June 1, 2021 is foreseen. During this period, sponsors will be 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 June 2021, use of the VGO will become mandatory.
Dutch Clinical Research Foundation
The new working method is based on the Local Feasibility procedure as developed by the Dutch Clinical Research Foundation (DCRF) jointly with CCMO and scientific societies. In short, the new working method ensures that the feasibility in the participating centres has been taken care of before the review committee assesses the clinical trial, instead of – as is presently the case – afterwards. The current procedure means that, after approval by the review committee, it often takes month before trials can start. The aim of the new procedure is that the trial can start immediately after approval of the clinical trial by the review committee.
What does this mean for the research file that you have to submit to the review committee? In the new procedure, the VGO replaces the current Research Declaration. If you wish to make use of the new procedure as from 1 December 2020, you must submit a signed part A of the VGO and a Clinical Trial Agreement (CTA) in accordance with the new procedure. Templates by the DCRF for the required CTA will become available on the CCMO website on 1 December. 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.
Until 1 June 2021, sponsors may still use the current Research Declaration. In that case, a Research Declaration and a CTA in accordance with the current procedure (industry-sponsored research or investigator-initiated research) must be part of the research file to be submitted.
Mandatory as of 1 June 2021
The modified procedure will apply to all monocentre and multicentre research in the Netherlands subject to the Dutch Medical Research Involving Human Subjects Act (WMO). From 1 June 2021 the new procedure will become mandatory and sponsors will have to submit a signed part A of the VGO to the review committee for each participating centre. From this date, it will no longer be possible to follow the old procedure. The CCMO External Review Directive will be adapted accordingly.
Evaluation new procedure
The DCRF and CCMO will jointly evaluate the new local feasibility procedure and the use of the VGO. The outcome of this evaluation will determine whether the procedure needs modifications. This evaluation will be completed no later than December 1, 2021.