If the proponent has submitted an unsigned version, the proponent must submit a signed clinical trial agreement to the audit committee before the start of the study. The attached letter indicates whether the provisions of the signed research contract, assessed by the Review Committee, have been amended. This is based on the principle that the signed version must be the same as the version approved by the Review Committee. 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. 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. 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. 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. 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).