When reviewing the Clinical Trials Agreement, an Accredited Medical Research Ethics Board (MREC) and the CCMO will comply with the CCMO Directive on the Evaluation of Clinical Trial Agreements. This Directive shall apply to research falling within the scope of the CMO and where there is a written agreement between the parties to the financing, setting up and carrying out of the research. 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. Two models are available: one for industry-supported research and the other for research initiated by researchers. Involved are the Cooperating Top Clinical Training Hospitals (STZ), the Dutch Federation of University Clinics (NFU), the Association of Innovative Medicines, the Foundation Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital (NKI/AvL) and the Association of Contract Research Organisations in the Netherlands (ACRON). 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. 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. The Directive will enter into force on 1 January 2009. As of that date, ethics committees will verify the compliance of clinical trial agreements with the CCMO Directive. If you submit a Declaration of Suitability for Location (VGO) to explain the local feasibility of the study, you must also submit a clinical study agreement in accordance with the new local feasibility procedure. The Dutch CENTRAL COMMITTEE for Medical Research in Humans (CCMO) has drawn up a directive on the evaluation of agreements on clinical traces. Companies may need to adapt their (presentation) agreements on clinical trials accordingly. For this reason, the CCMO has decided to set conditions concerning: (i) the provisions contained in the agreements for the early termination of research and (ii) the provisions relating to the disclosure of research results. The CCMO wants to prevent an independent publication of negative research results from being blocked by one of the two parties involved, though. B delays remain possible for patent reasons. In addition, the possibilities for early termination of research are limited and subject to strict rules. Contracts can no longer be terminated prematurely, for example.
B due to the mere decrease in the sponsor`s (commercial) interest in the research results. If the sponsor has submitted an unsigned version, the sponsor must submit a signed Clinical Trials Agreement to the Review Committee at the time of the first application before the start of the trial. . . .