Progress report
In general, the sponsor is required to inform the review committee (MREC or CCMO) which assessed the IVD performance study on the progress of the study annually.
A progress report contains at least:
- The number of subjects included (including those who left the study prematurely),
- An assessment of the extent to which research objectives are being met,
- Adverse events and other reports which may be important in assessing the progress of the study.
A sample form is available that shows which questions are to be answered.
Please note: this form is only a example of the questionnaire you have to complete online. It cannot be filled in or submitted as such.