K3. Clinical trial agreements
When reviewing the clinical trial agreement an accredited medical research ethics committee (MREC) and the CCMO will follow the Revised 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.
A signed copy of the clinical trial agreement between the party organising the research (sponsor) and the investigator and/or institution must be available for the reviewing committee before approval can be given. The reviewing committee decides whether a signed copy should already be included with the primary submission of the research file or whether this can be submitted later. In the latter case, an unsigned copy should be included in the research file for primary submission. In the case of multicentre research, a positive decision from the reviewing committee can follow if at least one signed clinical trial agreement is reviewed and approved. The clinical trial agreements of the other participating centres can be submitted as an amendment together with the Research Declarations.
If there is no clinical trial agreement, this must be mentioned in the cover letter. Without such a mention, the research file will be considered incomplete as long as the clinical trial agreement is missing.
The review of the clinical trial agreement is limited to the following two aspects, on the basis of the CCMO directive on the 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 reviewed.
You can use the template clinical trial agreement written by a collaboration of parties united in the Dutch Clinical Research Foundation (DCRF). These parties include the Samenwerkende Topklinische opleidingsZiekenhuizen (STZ) and the Netherlands Federation of University Medical Centres (NFU).
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.
In the case of multicentre research, if clinical trial agreemenst 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 centres. This must mention that the clinical trial agreements for the other centres are similar to the reference clinical trial agreement with regards to the two aspects reviewed by the accredited MREC or the CCMO, in accordance with the CCMO Directive on the Assessment of Clinical Trial Agreements. If such a statement is not included, then the signed clinical trial agreements must be submitted for all the participating centres.