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SUSAR Reporting to TGA and Privacy Requirements SOP

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

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

2. Expedited SUSAR Reporting to TGA

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

3. Privacy and Data Protection

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

4. Narrative Preparation

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

5. DSUR and Periodic Reports

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

6. Documentation and Archiving

1. Maintain SAE Case Files, SUSAR Logs, and Privacy Compliance Logs.
2. 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

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

References

• TGA — Safety Reporting Requirements
• ICH E6(R2) Good Clinical Practice
• ICH E2A: Clinical Safety Data Management
• ICH E2F: Development Safety Update Report
• Australian Privacy Act 1988

Version: 1.0

Approval

Annexures

Annexure-1: SAE Reporting Form

Annexure-2: SUSAR Submission Log

Annexure-3: Privacy Compliance Log

Revision History

For more SOPs visit: Pharma SOP.