Post approval project management

Post approval project management including amendments, progress reports, safety reports, breaches, audits and archiving.

Monitoring research

Alfred Health has a responsibility to monitor research in accordance with the Australian Code for the Responsible Conduct of Research and the National Statement on Ethics Conduct in Human Research (2023).

Monitoring occurs through:

  • Progress reporting
  • Review of adverse events
  • Review of deviations from the proposed research plan
  • Review of reports from researchers and safety monitoring boards
  • Review of audit reports
  • Key performance indicators
  • Feedback from participants

Researchers must monitor their research in accordance with the National Statement and complete progress reports and report adverse events and unexpected outcomes promptly to the Office of Ethics & Research Governance.