3.9 Trial Treatment

SERIOUS ADVERSE EVENT REPORTING

Example of an SAE form

Example of Adverse Event reporting procedure

UNBLINDING

Unblinding of the trial treatment should remain an exceptional event and depends on the requirements of the trial. However, it may be appropriate to break the code in certain medical emergencies in response to a critical medical situation experienced by the patient. Any code breaking must be decided by the investigator and discussed (unless this is not possible) with the coordinating centre and notification sent in writing.