Revision of the Site Suitability Declaration (VGO)
The Dutch Clinical Research Foundation (DCRF) has revised the Site Suitability Declaration (VGO). The aim of this revision is to make the document more in line with the daily practice of participating centres. In addition, ambiguities have been removed as much as possible. The new VGO does not entail any additional obligations.
The VGO was developed as a two-part instrument in the implementation of the Clinical Trial Regulation (CTR) in the Netherlands. On the one hand, the form provides the mandatory information for drug research on the suitability of participating centres. On the other hand, the VGO formalizes and facilitates a fast start-up route of drug research in the hospital.
The main changes in the revised VGO are:
- Replacement of VGO ‘part A’ and ‘part B’ with ‘Site Suitability Declaration (VGO)’ and ‘Appendices’.
- The instruction accompanying the statement and the appendices has been amended to clarify the process.
- On the first page, the word ‘equivalent’ has been added. The local agreements on which the signature of the VGO is based can be recorded both in the completed appendices and in a local document to the same effect.
- On the first page, a footnote adds that researcher-initiated monocentre study does not require a Clinical Trial Agreement (CTA), but separate Board of Directors/management approval is sufficient.
- The first page includes a question on the number of study participants planned for inclusion for the participating centre. This is in response to European laws and regulations.
Instruction sheet at VGO
In addition to the revision of the VGO, the DCRF has developed an instruction sheet that illustrates how the central assessment and local start-up should take place in parallel, and what the formal steps are in the local feasibility process.
The instruction sheet shows that the following three questions are answered during the process, with the last two running parallel to each other:
- Can the research centre carry out the study (VGO)?
- Is the research centre competent to carry out the study (review committee)?
- Will the research centre carry out the study (research contract/CTA)?
Local feasibility procedure and local feasibility checklist
The DCRF has updated the Local Feasibility Procedure and the Local Feasibility Checklist to align with the new VGO and instruction sheet. Both documents are available on the DCRF website.
CCMO guideline Assessment of suitability of research institute
The VGO is part of the CCMO guideline on Research Institution Suitability Testing. The formal procedure to amend the guideline is currently under way. In view of this procedure, a transition period is being applied for the use of the new VGO. This means that until 1 June 2023, both the old VGO (Part A) included in the CCMO guideline for Research Institution Suitability Testing and the new VGO can be used. From 1 June 2023, only the revised version of the VGO will be accepted.