In the case of multi-centre research, clinical trial agreements require at least one clinical trial agreement for verification of the research record. This is the reference agreement for clinical trials. For other Dutch centres, a written declaration from the sponsor is sufficient. The statement states that the clinical trial agreements concluded for the other centres are similar to the reference agreement for clinical trials with regard to the two aspects examined by the audit committee. If such a statement is not included, clinical trial agreements for all participating centres must be submitted. If a clinical trial is not concluded, the cover letter must indicate this. In the absence of such a statement, the Audit Committee considers that a clinical trials agreement is part of the research dossier. In the absence of agreement on the clinical trial, the audit committee will consider the research dossier to be incomplete. If the sponsor has submitted an unsigned version, the sponsor must submit a signed Clinical Trials Agreement to the Audit Committee at the time of the first application prior to the start of the trial. In the attached cover letter, you must indicate whether the provisions evaluated by the evaluation committee have been modified in the signed research contract. This is based on the principle that the signed version must be the same as that approved by the review committee.
An amendment to both aspects of the Clinical Trials Agreement, which are reviewed by the Review Committee – the criteria for early termination and publication of study results – is considered a significant change and is re-evaluated by the Review Committee. In the attached cover letter, you must clearly indicate the changes made. Again, a signed clinical trial agreement for information purposes must be submitted to the review committee after approval of the amendment. For more information, see the initial assessment procedure described above. Proper version control and an accurate description of the changes made to the different versions are of the utmost importance in order to reach an agreement of the audit committee quickly. If there is a clinical trials agreement, this agreement is part of the primary submission of the research dossier to the audit committee (MREC or accredited CCMO). The research sponsor may first submit an unsigned version. The submitted clinical trial agreement must have a reference and version number.
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: the CCMO considers that the clauses relating to the early termination of the study and the publication in these models are in line with the CCMO Directive on the Evaluation of Clinical Trial Agreements. . . .