In the case of multi-centre research, if clinical trial agreements have been reached, at least one clinical trial agreement is required for the review of research records. This is the benchmark agreement for clinical trials. A written declaration from the promoter is sufficient for the other Dutch centres. The statement indicates that the clinical trial agreements for the other centres are similar to those of the clinical trial agreement on the two aspects reviewed by the Review Committee. If such a declaration is not included, clinical trial agreements for all participating centres must be submitted. To prepare the clinical trial agreement, you can use models written by a collaboration of parties gathered within the Dutch Clinical Research Foundation (DCRF). Two models are available: one for industry-funded research and the other for research initiated by researchers. Participants participated in Top Clinical Training Hospitals (STZ), the Netherlands Federation of University Medical Centers (NFU), the Association of Innovative Medicines, the Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital (NKI/AvL) and the Association of Contract Research Organizations in the Netherlands (ACRON). Contracts and agreements should come into effect before the start of a trial and be subject to periodic review to ensure they remain up-to-date and relevant. The revision of the clinical trial agreement is limited to the following two aspects, based on the CCMO Directive on the Evaluation of Clinical Trial Agreements: If you submit a Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO) to explain the local feasibility of the trial, you must also submit a clinical trial agreement in accordance with the new local feasibility procedure. A change in the two aspects of the clinical trial agreement, which are reviewed by the Review Committee – the criteria for early completion and publication of study results – is considered a major change and will be reassessed by the Review Committee.

You must clearly state the changes made in the attached letter. Again, a signed clinical trial agreement for informational purposes must be submitted to the review committee after approval of the amendment. More information about this can be found in the initial evaluation procedure described above. Adequate control of the versions and an accurate description of the changes made in the various versions are of the utmost importance for the audit committee to proceed quickly with a settlement. Contracts and agreements can be concluded at many levels; Both inside and outside, both legally and legally. Examples include: if there is no agreement on clinical trials, this should be stated in the cover letter. In the absence of such a statement, the Review Committee will consider that an agreement on clinical trials is part of the research record. If the clinical trial agreement does not exist, the review committee will consider the research files to be incomplete. In reviewing the Clinical Trials Agreement, an accredited medical research ethics committee (MREC) and the CCMO will follow the CCMO Clinical Trial Agreement Evaluation Directive.

The directive applies to research within the scope of the WMO and where there is a written agreement between the parties to fund, organize and conduct the research. For non-commercial trials conducted in England, the HRA statement of activities can be used as an agreement between the sponsor and a participating website and can be found on the HRA website. The CCMO considers that the clauses relating to the early closure of the study and publication in these models are in line with the CCMO Directive on the Evaluation of Clinical Trial Agreements.