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.
You are required to submit a progress report one year after the issuing of the decision, and every subsequent year. You can do so by submitting the Progress Report form in the Research Portal.
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.
A sample form is available, showcasing the questions to be answered.
Attention: This form is only a sample template of the questionnaire that must be completed online. It cannot be filled in or submitted in this format.