Components
The annual progress report should contain the following data
- The number of patients that
- were screened
- were randomised
- Stopped study medication early/left the study early
- Died
- Terminated the study
- are being followed up
- A list of
- All submitted amendments and notifications throughout this year
- SARs
- Protocol violations/deviations
- Date of submission of the insurance certificate update with specification of the expiry date of this certificate.
- End date of inclusion, if applicable
- Scheduled end date of the study
Submitting a progress report
Your progress report can only be submitted digitally (via ec@uzleuven.be) using this template.