Research

Report a safety issue or adverse event

This page explains what safety information must be reported at Austin Health, when it must be reported, and how to submit it through Research Architect.

This process ensures compliance with:

  • NHMRC National Statement on Ethical Conduct in Human Research (2025) – effective early 2026
  • NHMRC Guidance: Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (2016)
  • Therapeutic Goods Administration (TGA) requirements
  • ICH-GCP E6(R3) (2025)
  • Victorian Managed Insurance Authority (VMIA) obligations (where applicable)
  • Last updated: 22 September 2025 – Next review: September 2026

What must be reported

Investigators at Austin Health

Investigators at Austin Health must report via Research Architect:

  • Significant Safety Issues (SSIs), including Urgent Safety Measures (USMs), trial halts, or early terminations.
  • SUSARs / USADEs possibly, probably, or definitely related to study conduct at Austin sites.
  • Annual Safety Reports and Investigator Brochure (IB) updates supplied by the Sponsor.
  • Do not submit routine SAEs to Austin Health. These are reported directly to the Sponsor unless classified as an SSI, USM, or SUSAR.

Sponsors

Sponsors must provide:

  • SUSARs, SSIs/USMs, IB updates, and Annual Safety Reports to the site PI for submission into Research Architect.
  • Direct reports to the TGA and to the Reviewing HREC (if not Austin Health).

Reporting timeframes

Report type

Defintion

Timeframe
Urgent Safety Measure (USM) Immediate action taken to eliminate an unforeseen hazard to participants   Within 72 hours of implementation
Significant Safety Issue (SSI) New safety info that materially alters participant risk or trial conduct  Within 72 hours
SUSAR – fatal/life-threatening

Suspected Unexpected Serious Adverse Reaction

  Within 7 calendar day
SUSAR – all other

Suspected Unexpected Serious Adverse Reaction

  Within 15 calendar days
USADE Unanticipated/Unexpected Serious Adverse Device Effect  Within 7 or 15 days (same as SUSARs)
Annual Safety Report Annual sponsor report of global and local safety information  With annual progress report submission
IB updates /amendments Investigator Brochure or protocol amendment containing safety updates  With the amendment submission
Other SAEs Serious Adverse Events not classified as SSI/USM/SUSAR  As per protocol (24 to 72 hours; deaths immediately)

Critical to know

Deaths or life-threatening SAEs must be reported immediately, with follow-up details provided as soon as available.

Note on timeframes

Timeframes apply to reports submitted via Research Architect by the Investigator (site PI). Sponsors separately meet their reporting obligations to the TGA and to the Reviewing HREC (if not Austin).

Responsibilities and accountability

Golden rule

All safety information relevant to Austin Health participants, staff, or resources must be submitted through Research Architect by the site PI (or delegate).

In addition:

  • Investigators never report directly to any HREC.
  • Sponsors originate reports, but the PI is responsible for uploading them into Research Architect.

What happens next depends on whether Austin Health is the Reviewing HREC or not.

If Austin Health is the reviewing HREC

The Investigator (via Research Architect) submits:

  • SSIs and USMs (< 72 hours)
  • SUSARs/USADEs involving Austin participants (7 or 15 days)
  • Annual Safety Reports via progress report
  • IB updates / amendments

The Discovery & Innovation Unit (DIU) forwards reports to the Austin Health HREC for review.

The Sponsor continues to report to the TGA (and any global regulators).

If another HREC is the Reviewing HREC

The Investigator (via Research Architect) submits to Austin DIU (for governance oversight):

  • SSIs and USMs involving Austin Health participants (< 72 hours)
  • SUSARs/USADEs involving Austin Health participants (7 or 15 days)
  • Annual Safety Reports and IB updates only where these change the risk/consent profile or otherwise impact Austin participants

The Sponsor is responsible for also reporting directly to the Reviewing HREC and the TGA.

Submissions in Research Architect to ensure Austin Health maintains a complete governance record of issues affecting its participants, staff, or resources.

How to report at Austin Health

  1. Log in to your project in Research Architect.
  2. Go to the Parent Case and select Safety Incident.
  3. Complete the online form (templates are available in the portal).
  4. Upload supporting documents if required.
  5. Select Submit. The DIU is notified automatically.
  6. Confirmation: The submission is recorded in your project as proof of receipt.

Research Architect is the only accepted pathway. Email submissions will not be processed.

Access Research Architect

Visit the Knowledge Base on Research Architect to download the Research Architect user guide.