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Annual and Final/Site Closure Reporting

 

Annual Progress Reports

In accordance with the NHMRC National Statement on Ethical Conduct in Human Research 2023, it is the researchers’ responsibility to provide reports of the progress of approved research projects at least annually, and related to the degree of risk to participants, to lead HREC.

The report must be completed by the lead Principal Investigator (PI) for all clinical trials and health/medical research projects approved by the CALHN Human Research Ethics Committee (HREC). The report is due on the anniversary of lead HREC approval. This report incorporates both CALHN ethics and CALHN governance review. Continuation of CALHN ethics approval and CALHN governance authorisation (where applicable) is contingent on the submission of this report, due within two weeks of the approval anniversary. Where an external site(s) is participating, the site PI must also report to their institution via their local Research Governance Office. Failure to comply may result in suspension of the project.

Please note: Where CALHN is not the lead HREC, an external Annual Report and corresponding approval from lead HREC is required for governance review by CALHN. Governance submissions using CALHN templates will not be accepted.

Final Reports and Site Closure Reports

In accordance with the National Statement on Ethical Conduct in Human Research 2023, it is the researchers’ responsibility to provide a final report for completed research projects and for all site closures to review the lead HREC.

The report must be completed by the lead Principal Investigator (PI) for all clinical trials and health/medical research projects approved by the CALHN Human Research Ethics Committee (HREC). This report incorporates both CALHN ethics and CALHN governance review. Where the report pertains to completion or a site closure at an external site, the site PI must also report to their institution via their local Research Governance Office.

Please note: Where CALHN is not the lead HREC, an external Final/Site Closure Report and corresponding approval from lead HREC is required for governance review by CALHNGovernance submissions using CALHN templates will not be accepted.

To access the CALHN Research Progress Report Forms click here.

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.

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