Monitoring Research Projects

Research » Post Ethics & Governance Approval » Monitoring Research Projects

Monitoring Research Projects

The Northern Health Office of Research and Ethics (NHORE) monitors approved projects to ensure compliance with the protocol and relevant legislation and guidelines as per HREC and research governance approval. The  mechanisms for monitoring are as follows:

1. Annual Reports (including DSMB reports and multi-site approvals)
 An annual report must be submitted to the approving HREC and NHORE by the PI (or delegate) at the anniversary of the HREC approval date or as per HREC requirements. The annual report is submitted on the approved Department of Health & Human Services approved Site Report Form.

Annual reports not received within 4 weeks of the anniversary due date may result in the suspension of the research project.

2. Final Reports (including multi-site approvals)
 A final report must be submitted to the NHORE by the PI (or delegate) at the completion of a research project or if the project is discontinued or abandoned. The final report is submitted on the approved HREC Final Report Form.

3. Safety Reports
 The NHORE monitors approved research projects via the safety reports. A log of Serious Adverse Events is kept.

4. Protocol Deviation/Violation
 Protocol deviation/violation reports must be sent to the NHORE if the deviation/violation occurred at a NH site and impacts on patient’s safety or the overall conduct of the trial. A Riskman may also be requested to be completed.

5. Monitoring & Auditing visits 
The NHORE may conduct on site monitoring and auditing. The purpose of the auditing program is to review how research is conducted, and to detect, correct and prevent potential and existing problems.

The objectives of the auditing program are:

a)   to ensure research is conducted ethically, safely, legally and in compliance with the protocol; conditions of HREC approval and institutional policies & procedures.
b)   to raise awareness of requirements and promote researchers' accountability.
c)   to ensure that the conduct of research does not compromise the integrity of the results.

All ongoing human research projects conducted at Northern Health sites with ethics approval are eligible to be audited, including clinical trials, observational studies, clinical audit activities and public health research projects.

The NHORE may recommend that safety issues are logged in Riskman as a near miss or incident, escalation to the NH HREC and/or suspend the project at NH.

Click on this link to download the standard templates for self-audit accepted by NHORE.

For further guidance on Monitoring & Reporting go to the DHHS website

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