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Post Approval Monitoring and Reporting

 

In accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research 2023 the institution, the lead HREC and investigators must ensure that research continues to conform to approved ethical standards and adheres to institutional requirements.

CALHN Research Services is tasked with monitoring all approved studies until their completion. This necessitates regular communication and reporting to CALHN Research Services. 

Continuation of CALHN ethics approval and CALHN governance authorisation is contingent on submission of annual reports. Failure to comply will result in the suspension or termination of HREC approval or RGO authorisation. All Annual Reports are due on the anniversary of ethics approval or the date specified by lead HREC. 

For inquiries regarding annual reports and further information, please contact CALHN Research Services at 08 7117 2218 or via email at Health.CALHNResearchMonitoring@sa.gov.au.

For inquiries regarding amendments to studies, safety, protocol deviations and breaches, please contact CALHN Research Services at 08 7117 2223 or via email at Health.CALHNResearchMonitoring@sa.gov.au.

Please note: CALHN HREC and RGO annual progress report and final report submissions are processed separately to amendment submissions.

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