The Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO) is a declaration of feasibility of a clinical study in a (research) centre in the Netherlands. It’s a new document that replaces the current Research Declaration for studies subject to the Medical Research Involving Human Subjects Act (WMO) in the Netherlands. It is part of the new procedure Local Feasibility.
Use of the VGO becomes mandatory for drug trials from 1st November 2021, for non-drug trials from a date to be determined in 2022. The CCMO (Central Committee on Research Involving Human Subjects) is currently updating the Richtlijn Externe Toetsing (RET) to reflect this new procedure.
With Diagram’s commitment to quality and adherence to laws and regulations, Diagram Research recruited Eric Klaver, Quality Consultant (Trial & Eric), to integrate the VGO into their protocols and to train their employees on its usage.
VGO cuts life-threatening delays
Implementation of the VGO signifies a strong step forward towards a faster and more streamlined process from the initial Research Declaration until the start of the study. By pulling the local feasibility assessment forward, the VGO cuts out the time delay that currently exists between the Ethical Committee’s positive decision and the study’s starting date.
Klaver explains that improving the total timeline has multiple major consequences:
- Improved health care: the sooner trials and studies conclude, the sooner their results can be used to develop new innovative treatments and to make new medicines available to patients;
- More efficient use of resources since delays in research are costly;
- Global relevance: “If we, the Netherlands, want to stay relevant as a research country, we have to make sure our research procedures are flawless. Any delays caused by the system itself have to be eliminated”.
Main steps in new procedure Local Feasibility
Step 1: VGO Part B | Overview of agreements local principal investigator and relevant departments
The new procedure Local Feasibility requires the sponsor to provide a detailed overview of the Study Information, called the VGO Part B. This information includes (but isn’t limited to) the type of research, procedures, medication, number of patients and centres, involved departments, budgets and financial responsibilities.
VGO Part B has to be agreed upon between the PI and all relevant departments.
Step 2: VGO Part A | Site Suitability Declaration
The PI submits the VGO Part A & B to the Board of Directors/Management to assess local feasibility and asks to sign VGO Part A. By signing Part A, the Board of Directors/ Management of the research institute declares that the centre is capable to perform the intended research.
The signing of Part A has to be arranged before the date the sponsor intends to submit the study to CTIS, the European Clinical Trial Information System, in order to participate in the study. If the site were to be late getting Part A signed, it would miss the initial submission. Adding the site afterwards would be a substantial amendment, which cannot occur until 3 months after the initial approval.
Step 3. VGO Part A submission to the Ethics Committee
The sponsor submits the VGO to the Ethics Committee through CTIS. In parallel, the sponsor and the centre work to reach agreement on the Clinical Trial Agreement (CTA) before the review period is over.
Step 4. Start research
Upon receipt of a positive decision from the Ethics Committee, the study can start immediately since all relevant approvals are already in place.
Start saving time and lives today
Today, you’re still allowed to submit the current Research Declaration for the assessment of the suitability of participating centres.
However, since the VGO becomes mandatory in only a few months, Klaver advises to already start using the VGO and gain experience with the new procedure Local Feasibility. It will save crucial time.
Diagram Research can support you in implementing the new procedure Local Feasibility. Get in touch here.