During and after the study: reporting to the accredited MREC

The sponsor is required to report the following to the accredited MREC which has issued a positive decision:

  • start and end date of the study;
  • substantial amendments;
  • progress reports;
  • SAEs en SADEs;
  • suspension or (premature) termination of the study;
  • clinial trial report.

Based on article 10,  paragraph 1 of the Medical Research Involving Human Subjects Act (WMO) the sponsor is responsible for the reporting of Serious Adverse Events (SAEs) to the reviewing committee (MREC or CCMO), with the exception of SAEs that require no reporting according to the clinical protocol.

SAEs that were fatal or life-threatening for the patient must be reported within 7 days after the sponsor has taken notice of this event. Other SAEs must be reported within 15 days.

SAEs that require no immediate reporting according to the protocol can be reported in periodic line listings and the development safety update report. In some cases SAE reporting can be waived. The procedure of SAE reporting needs to be recorded in the clinical protocol (or in an addendum of the protocol). The Central Committee on Research Involving Human Subjects (CCMO) composed in collaboration with the NVMETC (Dutch Society of MRECs) a guidance document (in Dutch) about the reporting procedure of SAEs. More information about the reporting of SAEs can be found here.