Checklist for adverse event reporting

An adverse event form should be provided by the Co-ordinating Centre. (If the trial is supported by Industry they may provide this. If so they should, ideally, be customised to the trial).
The Co-ordinating Centre should devise a system for ensuring that all such events are reviewed by the PI, and/or Steering Committee Chairman, and/or DMC depending on the seriousness of the event.
If an event warrants informing the MCA, based on the criteria set out in their documentation, the collaborative group must be told that such events have occurred. The MREC should also be informed.
Always keep clear records of any serious unexpected/adverse events.

Serious adverse event

Definition:- A serious adverse event is one which is fatal or life threatening, disabling or incapacitating, requires or prolongs hospitalisation, causes/results in congenital anomaly/cancer or is irreversible.
It may not be necessary to report events which are serious BUT expected eg. a stroke in a stroke trial.

Serious unexpected events

Definition: An unexpected serious event is one which is not anticipated, not known to be related to the disease being studied or the intervention being used. These need to be reviewed using the event reporting system

Minor adverse events (including adverse reactions and side effects)

Decide with the Principal Investigator how minor adverse events will be dealt with within the trial. Minor side effects are usually those which are not serious and may be due to the intervention.