Post-approval reporting2021-03-16T16:54:31+10:00

Post-approval reporting

While undertaking a research project, researchers have an obligation to both the participants and to the Human Research Ethics Committee (HREC) and Research Governance Officers to provide reporting and monitoring.

Commencement, annual and final reporting

The commencement form should be sent as soon as the study commences. Use the start date rather than the date the first participant is successfully recruited.

For research studies to receive ongoing ethical approval, an Annual Report is due by the 30th April each year.  Once a study has finished, please submit a Final Report together with a copy of the final results and any publications.

Reporting adverse events

Unless otherwise stipulated in your approval letter, for externally-sponsored clinical trials being conducted at Metro North HHS, the attached NHMRC guidance document applies to safety monitoring and reporting for clinical trials involving therapeutic products NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods

What should be reported to the HREC?

  • Urgent Safety Measures (USMs) instigated by the Site or Sponsor within 72 hours of becoming aware of the event
  • All other Significant Safety Issues (SSIs) should be notified within 15 calendar days of the sponsor instigating or being made aware of the issue
  • An annual safety report including a clear summary of the evolving safety profile of the trial
  • Investigator Brochure amendments
  • Data Safety Monitoring Board (DSMB) reports

What should be reported to the RGO?

  • Urgent Safety Measures (USMs) instigated by the Site or Sponsor within 72 hours of becoming aware of the event
  • Suspected Unexpected Serious Adverse Reactions (SUSARs) or Unanticipated Serious Adverse Device Effects (USADEs) arising from the local site, within 72 hours of becoming aware of the event or change in status from SAE to SUSAR
  • All other SSI that result in temporary halt, amendment or early termination of a trial within 72 hours of becoming aware of the event
  • An annual safety report including a clear summary of the evolving safety profile of the trial
  • Investigator Brochure amendments
  • Data Safety Monitoring Board (DSMB) reports

What should NOT be reported to the HREC or RGO?

  • Single Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs) and Adverse Events (AEs) that do not affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
  • External SUSARs or device/non-therapeutic good equivalents
  • Six monthly line listings

What if Metro North HHS are the sponsor of the clinical trial?

For studies where Metro North HHS is the sponsor, please notify all safety events for all sites for which Metro North HHS is responsible through to the relevant Metro North HHS research governance office.

Amendments

Remember that HREC approval is required for any amendments to the protocol, PICF s, advertisements, radio scripts, questionnaires, patient cards, etc.

Please refer to the single and multi-centre amendment checklist and forward one set of papers with a covering letter from the Principal Investigator explaining the amendment rationale and whether/how it will affect the study.  Please also provide an electronic copy of all documentation.

Ensure that all documents submitted for approval contain document identifiers, version numbers, dates and page numbers.

Amended documents also need to have the changes highlighted (use the Microsoft Word Track Changes feature for this).

Data archiving, retention and disposal