M1. Progress report

The sponsor must inform the MREC at least once a year at least once a year on the progress of the ongoing research. For the progress report you can use the MREC progress report form.

A progress report at least includes the following:

• the number of subjects included (including those subjects who have 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 for review of the study’s progress.

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.

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M1. Progress report

^{Participating institutions: UMC Utrecht, Prinses Máxima Centrum for pediatric oncology and Antoni van Leeuwenhoek}