What is the procedure?
If there is a serious protocol deviation, please notify our MREC as soon as possible. You should state which actions have / will be taken to prevent this deviation in the future. Other deviations may be submitted in a periodic statement.
Deviations are presented to the chairman of the MREC as a notification. In case questions arise, we will contact you.
What should I submit?
What should I pay attention to?
A periodic overview of deviations may be provided together with the annual progress report (APR).