Reporting

All research projects are subject to reporting requirements as a condition of approval:

• Investigators must submit an annual progress report. You can use the annual project progress report and extension request template
• Investigators must submit a final report when the research is complete. You can use the final report template
• Principal Investigators must provide regular reports at least annually on matters including:
  • unforeseen events that could affect the continued ethical acceptability of the project
  • proposed changes in the protocol
  • updates of the investigator brochures
  • continued compliance with approved consent procedures and updates of consent documentation
  • data safety monitoring board reports (where applicable)
  • security of records
  • updated insurance coverage
  • compliance with other approved procedures.

Additional reporting requirements

For some projects additional reporting will be required to ensure the ongoing safety for participants. This may include:

Safety reporting for clinical trials

Sponsors must provide the Research Ethics and Governance Office with an annual safety report that supports trial oversight. This is done through the local principal investigator. The report includes a clear summary of the evolving safety profile of the trial and evidence that the sponsor is conducting its own ongoing safety monitoring appropriately. If there is any new safety information the sponsor will be required to provide an updated participant information and consent form.

Sponsors are required to review the investigator brochure at least yearly. They need to provide updates to investigators and the office.

Sponsors must provide the office with reports of data safety and monitoring boards.

Investigators are obliged to review the safety information that is sent to them by the trial sponsor and to act on all safety advice. The investigator has primary responsibility to ensure that all investigators are up to date on all aspects of the safety of their protocol.

Questions of product or protocol safety are relevant to the conduct of any clinical trial. It is the responsibility of the investigator to be aware of and act on the latest available safety information. The investigators should discuss this information with participants as part of the ongoing assurance that consent is informed and remains valid.

Serious adverse event reporting

Serious adverse events that happen at Canberra Health Service sites, including Canberra Hospital, or involving trial participants enrolled through Canberra Heath Services must be reported. Go to the serious adverse event report form.

Protocol deviations

Any deviations from the approved protocol occurring at Canberra Health Services and Canberra Hospital must be reported. Protocol deviation logs must be submitted at least every six months. One deviation log needs to be submitted per trial. If a trial has had no deviations in the reporting period, you must submit a protocol deviation log to the office noting “nil deviations” and it needs to be signed by the investigator. Go to the protocol deviation log template.