Safety

Reporting of adverse events for FAST INdICATE

Adverse events will be reported to the Data Monitoring and Ethics Committee, set up in accordance with the Medical research Council Guidelines for Good Clinical Practice.

Adverse Events will be recorded from date of randomisation to end of trial.

Key:

yellow highlighted = person initiating the form (first aware of incident)
green highlighted = Principal Investigator (PI)
pink highlighted = Chief Investigator (CI)