K3. Clinical trial agreements
When reviewing the clinical trial agreement, an accredited medical research ethics committee (MREC) and the CCMO will follow the CCMO Directive on the assessment of clinical trial agreements. The directive is applicable to research that falls under the scope of the WMO and when there is a written agreement between the parties involved in the financing, set up and execution of the research.
Review of the clinical trial agreement
The review of the clinical trial agreement is limited to the following two aspects, on the basis of the CCMO Directive on the assessment of clinical trial agreements:
- The provisions with regards to premature termination of the scientific research or the agreement;
- The provisions with regards to the publication of the study results of the scientific research.
Please note that similar provisions in the research protocol will also be assessed by the review committee (accredited MREC or CCMO).
To prepare the clinical trial agreement you may use the template written by a collaboration of parties united in the Dutch Clinical Research Foundation (DCRF). These parties are the Cooperating Top Clinical Training Hospitals (STZ), the Netherlands Federation of University Medical Centers (NFU), the Association Innovative Medicines, Foundation the Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital (NKI/AvL) and the Association of Contract Research Organisations in the Netherlands (ACRON).
The CCMO considers the clauses regarding premature termination of the study and regarding publication in this model to be in line with the CCMO Directive on the assessment of clinical trial agreements.
Submitting the clinical trial agreement
If there is a clinical trial agreement, this agreement is part of the primary submission of the research file to the review committee (accredited MREC or CCMO). The sponsor of the research may submit an unsigned version initially. The submitted clinical trial agreement must have a reference and version number.
If the sponsor has submitted an unsigned version at the initial application, the sponsor must submit a signed clinical trial agreement to the review committee before the start of the study. The signed version must be the same version as the one approved by the review committee.
Any changes to the clinical trial agreement that lead to a new version must be submitted to the review committee for notification. A change concerning the two aspects of the clinical trial agreement that are reviewed by the review committee – criteria for early termination and publication of study results – is considered a substantial amendment and will be assessed by the review committee as such. Upon receipt of the signed version, the review committee will check whether this is the same version as the one she approved.
If there is no clinical trial agreement, this must be stated in the cover letter. Without such a statement, the review committee will assume that a clinical trial agreement is part of the research file. If the clinical trial agreement is absent the review committee will consider the research file to be incomplete.
In the case of multicenter research, if clinical trial agreements have been reached, at least one clinical trial agreement is required for the review of the research file. This is the reference clinical trial agreement. A written statement by the sponsor is sufficient for the other Dutch centers. In the statement it must be stated that the clinical trial agreements for the other centers are similar to the reference clinical trial agreement concerning the two aspects reviewed by the review committee. If such a statement is not included, then the clinical trial agreements of all participating centers must be submitted.