In accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research 2007 (updated 2018), the institution, the Human Research Ethics Committee (HREC) and investigators must ensure that research continues to conform to approved ethical standards and adheres to institutional requirements.

Central Adelaide Local Health Network (CALHN) Research Services is required to monitor all approved research and this can only occur through regular communication and reporting.

At a minimum, deviations/breaches from the approved study protocol must be reported to the reviewing HREC and Research Governance Office, and annual progress reports must be provided on the anniversary of the HREC approval.

Researchers conducting clinical trials of drugs and/or devices have additional safety-related reporting requirements. 

CALHN Guideline: Safety Monitoring and Reporting and Reporting Serious Breaches of Good Clinical Practice or the Protocol for Clinical Trials Involving Therapeutic Goods

CALHN Clinical Trial Reporting Requirements Table

For sponsored clinical trials migrated into Research GEMS, and for all research studies submitted via Research GEMS: post approval monitoring must be made via Research GEMS.

For investigator initiated health/medical research projects approved prior to Research GEMS release (17 December 2020): post approval submissions to the CALHN HREC must be made on the appropriate form available under the Post Approval Monitoring Forms tab below, submitted via email to [email protected] 

For any queries please email [email protected] or call 7117 2223