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M1. Progress report

The sponsor must inform the review committee (accredited MREC or CCMO) at least once a year on the progress of the ongoing research.

Is your research proposal reviewed by the CCMO? Then you are required to submit a progress report one year after the issuing of the decision, and every year thereafter. You can make use of the progress report template. Is your research not reviewed by the CCMO? Please ask the committee in question on their policy with regards to progress reporting.

Download the progress report template

A progress report contains at least:

  • the number of included subjects (including subjects that left the study prematurely);
  • an estimate of the extent to which research objectives are being met;
  • the adverse events and other notifications that may be important to review the progress of the study.

In the case of research with a medicinal product, the progress report may be combined with a Development Safety Update Report (DSUR). In that case the (international) fixed date for the DSUR may be leading.