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Safety reporting

Safety reporting for multi-centre studies

For multi-centre research projects, the Principal Investigator must report serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) occurring at the site directly to the reviewing HREC. The Principal Investigator will provide a copy of these reports to the site Research Governance Officer and Coordinating Investigator. All other safety reports must be submitted to the reviewing HREC by the Coordinating Investigator.

Safety Reporting for studies approved by St Vincent’s HREC

  1. Reports are submitted using the Serious Adverse Event and Suspected Unexpected Serious Adverse Event Form available on the standard forms page
  2. This report, and any supporting documentation must be submitted electronically, via email.
  3. For information regarding reporting requirements for medications and devices please refer to the ‘Definition and Guidance for Safety Reporting PDF [ 19 KB]

Annual safety reports and line listing submissions to the reviewing HREC

  1. Submit using the Letter template for submission of line listings and annual safety reports available on standard forms page
  2. This letter, and all associated listings/DSURs, must be submitted electronically, via email.

Safety Reporting to the St Vincent’s Research Governance Officer

For studies that are conducted at St Vincent’s & Mater Health Sydney network sites, but that have been reviewed by a Lead HREC other than St Vincent’s HREC, copies of reports to the approving HREC should be submitted to the Research Office along with HREC correspondence acknowledging the submission.

Please ensure that all submissions are accompanied by a cover letter that lists the study title, each document being submitted, and the St Vincent’s Research Office file number (usually a 5-digit number where the first 2 numbers indicate the year of submission, eg 13/001). This cover letter must be signed by the site Principal Investigator.

All correspondence must be submitted electronically, via email.

Incident reporting for Medical Devices

In addition to the requirements of the HREC and Research Governance Officer, safety incidents involving medical devices may require notification to the Australian Therapeutic Goods Administration (TGA). Please refer to the TGA website for information relating to the medical device incident reporting and investigation scheme (IRIS), and for reporting templates.