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.
- Has your investigation been assessed by an accredited MREC? If so, request information from the MREC concerned on its reporting policy.
- Has your research been assessed by CCMO? In that case you are required to submit a progress report to CCMO one year after the date of the assessment and every year thereafter. To this end you may use the CCMO form progress report.
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.