During the clinical trial a participant may experience so-called Adverse Events. The research protocol should describe how to deal with these types of events.
All Serious Adverse Events (SAEs) , Serious Adverse Reactions or Suspected Unsuspected Serious Adverse Reactions (SUSARs) must be reported to the reviewing MREC. Exceptions thereof can be described in the clinical trial protocol.
The reports may be comprised in a quarterly, semi-annual of annual line-listing. The line-listing mention events for which no immediate reporting is required.