Changes regarding submission of clinical trial agreement
From today, the signed version of the clinical trial agreement (CTA) may be submitted to the review committee (accredited MREC or CCMO) after the primary positive decision has been issued. From now on the (possibly still unsigned) CTA that is submitted for review must have a reference with a version number, so it is clear which version has been assessed by the review committee. A signed copy of the approved version must be submitted to the review committee before the study starts. This new procedure is now possible and also applies to research that has already been submitted for review to a committee.
In the past, the CTA itself had often already been approved by the review committee, but the signed version was not available yet. That caused a delay in issuing the decision. Therefore the period for the mandatory submission of a signed version of the CTA is no longer limited to the moment the review committee can draft the decision on the research, but has been extended to the moment the study will start. As a result, the review procedure will be more efficient and sponsors and investigators will sooner have the positive decision of the review committee at their disposal.
In summary, this means the following for the submission and review of the CTA:
- The submitted CTA must have a reference and version number.
- For multicenter research, one version is sufficient if the sponsor has declared that the CTAs from the other centres are similar to the reference CTA which has been submitted for review.
- The review committee assesses the two paragraphs in the CTA on the criteria for early termination and publication of the study results based on the CCMO Directive on the Assessment of Clinical Trial Agreements.
- Reference and version number of the approved CTA is mentioned in the decision letter of the review committee.
- A signed copy of the approved version of the CTA must be submitted to the review committee for notification before the start of the study. Upon receipt of the signed version, the review committee will check whether it is the same version as the one she has approved.
- Any change to the CTA that leads to a new version number must be submitted to the review committee. A change that relates to the two aspects of the CTA that the review committee assesses - criteria for early termination and publication of study results - is considered a substantial amendment and will be assessed by the review committee as such. In all other cases, the new version of the CTA only needs to submitted to the review committee for notification.
- The CCMO recommends using the DCRF template for the CTA.