| Annual Progress Reporting and Auditing |
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The Human Research Ethics Committee (HREC) is required to monitor research in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007). A condition of approval of all projects approved by a Melbourne Health HREC is that a report of project progress is submitted annually by the principal investigator.
In addition to submitting an annual progress report, investigators are also required to submit a final report, due on completion of the study, or if the research is discontinued before the expected date of completion.
"Completion" of a project means:
- For commercially sponsored clinical trials - a study is considered complete once the closeout visit has been completed.
- For investigator initiated clinical trials - a study is considered complete once the last patient has completed follow-up and the data have been analysed.
- For other research projects - a study is considered complete once data collection is complete and there is no further contact with patients or access to medical recodrds or other sources of personal health or information.
Further Information and Forms
Annual progress reports are due on the anniversary of the date of HREC approval. Continued ethical approval is contingent upon the provision of an annual progress report in a timely manner.
In order to ensure diligent governance of Research at Melbourne Health, the Office for Research will be introducing an additional monitoring scheme to that of annual progress reports to the HREC - site audit of research progress by the Research Governance Office and Investigator Self-Accreditation Audits.
Progress Report and Audit Forms
Based on the information provided in the annual report, the HREC may recommend a random inspection of the research site, data and signed consent forms, or that research participants be interviewed.
Researchers should also complete the following forms as required.
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