SOP for SUSAR Reporting to TGA and Privacy Requirements

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Published on 25/12/2025

SUSAR Reporting to TGA and Privacy Requirements SOP

Department	Clinical Research
SOP No.	CS/TGA-SAF/175/2025
Supersedes	N.A.
Page No.	1 of 22
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Table of Contents

Purpose

The purpose of this SOP is to define the requirements for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) and Serious Adverse Events (SAEs) to the Therapeutic Goods Administration (TGA). It ensures compliance with GCP, CTN/CTX obligations, and Australian privacy regulations while protecting subject safety and maintaining sponsor responsibilities for pharmacovigilance.

Scope

This SOP applies to all clinical trials conducted under CTN/CTX schemes requiring safety reporting to TGA. It includes expedited reporting of SUSARs, SAE documentation, case narrative preparation, ICSR submissions, and privacy protection requirements in line with the Australian Privacy Act and local institutional policies.

Responsibilities

Principal Investigator (PI): Identifies and reports SAEs to sponsor within 24 hours, provides causality assessment, and maintains documentation.
Clinical Research Coordinator (CRC): Completes SAE forms, verifies medical records, and assists in subject re-consent where applicable.
Pharmacovigilance (PV) Team: Performs medical review, prepares SUSAR narratives, and ensures submissions to TGA within mandated timelines.
Regulatory Affairs (RA): Confirms acknowledgments from TGA and ensures SUSAR submissions are filed in TMF.
Quality Assurance (QA): Reviews safety workflows, audits case files, and ensures privacy compliance.

Accountability

The Sponsor’s Qualified Safety Officer is accountable for ensuring accurate and timely SUSAR and SAE reporting to TGA. The Head of Clinical Research is accountable for monitoring compliance across trials.

Procedure

1. SAE and SUSAR Identification

Investigators record SAEs immediately upon awareness using SAE Report Form.
Determine seriousness, causality, and expectedness against Investigator’s Brochure (IB) or Reference Safety Information (RSI).
Forward initial SAE reports to sponsor PV team within 24 hours.

2. Expedited SUSAR Reporting to TGA

Fatal or life-threatening SUSARs: report within 7 calendar days, followed by complete data within 8 additional days.
All other SUSARs: report within 15 calendar days.
Reports must be submitted in E2B(R3) electronic format via TGA eBusiness portal.

3. Privacy and Data Protection

Ensure SAE/SUSAR forms do not contain direct identifiers (e.g., names, addresses) before submission.
Subject IDs and trial numbers must be used instead of personal identifiers.
Comply with the Australian Privacy Act 1988 and institutional data protection policies.

4. Narrative Preparation

PV team prepares comprehensive narratives including demographics, medical history, event description, treatment, and outcome.
Narratives must be translated into English if required and archived in TMF.

5. DSUR and Periodic Reports

Prepare annual Development Safety Update Reports (DSURs) for cumulative safety data and submit to TGA within 60 days of data lock point.
Provide summaries to HRECs as per institutional requirements.

6. Documentation and Archiving

Maintain SAE Case Files, SUSAR Logs, and Privacy Compliance Logs.
Archive safety records for 15 years or per TGA guidance.

Abbreviations

SAE: Serious Adverse Event
SUSAR: Suspected Unexpected Serious Adverse Reaction
DSUR: Development Safety Update Report
ICSR: Individual Case Safety Report
PI: Principal Investigator
PV: Pharmacovigilance
RA: Regulatory Affairs
QA: Quality Assurance
IB: Investigator’s Brochure
RSI: Reference Safety Information
TMF: Trial Master File
HREC: Human Research Ethics Committee

Documents

SAE Reporting Form (Annexure-1)
SUSAR Submission Log (Annexure-2)
Privacy Compliance Log (Annexure-3)

References

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: SAE Reporting Form

Subject ID	Event	Onset Date	Outcome	Investigator Assessment	Date Reported
AUS-101	Severe Anaphylaxis	10/08/2025	Recovered	Related	11/08/2025

Annexure-2: SUSAR Submission Log

Case ID	Subject ID	Event	Report Type	Date Submitted	Acknowledgment
SUS-301	AUS-102	Seizure	7-day Expedited	15/08/2025	Received

Annexure-3: Privacy Compliance Log

Date	Document	Privacy Check	Reviewer
20/08/2025	SAE Report – AUS-102	Identifiers Removed	Sunita Reddy

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for SUSAR reporting to TGA and privacy requirements.	New SOP created for compliance with TGA guidance and Australian Privacy Act.	Head of Clinical Research

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