Reporting adverse events during clinical trials

As a marketing authorisation holder you have a statutory obligation to report adverse events to the authorisation agencies. Sponsors of clinical studies of medicines and bodies carrying out the trials are also required to follow specific instructions for the submission of reports.

Submission via ToetsingOnline

Submitting parties for investigator-initiated research are obliged to report all adverse events/reactions (SUSARs and SAEs) via ToetsingOnline. The adverse events module in ToetsingOnline offers one portal for the submission to the Competent Authority (CCMO or Ministry of Health, Welfare and Sport), the Medical Ethics Committee (MEC or CCMO) and the MEB. In other words, SUSARs that are submitted via ToetsingOnline do not have to be submitted again to the MEB.

When submitting a SUSAR via ToetsingOnline, it is important to indicate whether the SUSAR has already been submitted to the EudraVigilance database of the EMA. If not, the Dutch SUSAR will be transmitted directly to Lareb (the Netherlands Pharmacovigilance Centre) and Lareb will take care of the data input in EudraVigilance.

For the time being, this functionality is only available for investigator-initiated research in ToetsingOnline. A similar obligation for commercial clinical research will follow in due course.

Reporting SUSAR reports

Clinical trials with a medicinal product fall under the Research Involving Human Subjects Act (WMO) and must first be approved  by an accredited medical research ethics committee (MREC or Central Committee on Research involving Human Subjects - CCMO) and a competent authority (CCMO or Ministry of Health, Welfare and Sport) for approval. The MEB is not the competent authority in the field of clinical trial authorisation.

Suspected Unexpected Serious Adverse Reactions (SUSARs) during a clinical trial with a medicinal product  must be reported to the competent authority (CCMO or Ministry of Health, Welfare and Sport), a review committee (MREC or CCMO) and the MEB. The disclosure obligation to the MEB has been met once the SUSAR has been sent to the EudraVigilance Clinical Trial Module (EVTCM).

As some sponsors of clinical trials with medicinal products have indicated that they wish to receive a formal, written confirmation of this approach, you can submit a waiver request for the reporting obligation to the MEB.