Progress report
The sponsor must inform the reviewing committee (MREC or CCMO) at least once a year on the progress of the ongoing research.
You are required to submit a progress report via the Research Portal one year after the decision has been issued, and then every subsequent year.
A progress report contains at least:
- the number of included research participants (including participants that 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 to review the progress of the study.