It is essential that all Principal Investigators are familiar with and comply with the requirements of the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).
Investigators should assess all local safety events and should act on any events as clinical care dictates. The role of the investigator with regard to safety reporting is to provide the sponsor with all relevant information so that an appropriate safety analysis can be performed.
The Principal Investigator should:
Investigators should report the following safety information only for participants at Western Health sites to the Western Health Office for Research: