SOP for Local SUSAR and SAE Notifications and Privacy Requirements

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Published on 22/12/2025

Local SUSAR and SAE Notifications and Privacy Requirements SOP

Department	Clinical Research
SOP No.	CS/NZ-SAF/202/2025
Supersedes	N.A.
Page No.	1 of 25
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 procedures for reporting Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in New Zealand, in compliance with Medsafe and Health and Disability Ethics Committees (HDEC) requirements. It also covers privacy obligations under the Privacy Act 2020 to protect participant data.

Scope

This SOP applies to all clinical trials conducted in New Zealand. It includes SAE/SUSAR detection, documentation, causality assessment, expedited reporting, DSUR submissions, and data privacy compliance. It applies to sponsors, investigators, CROs, PV officers, and regulatory staff.

Responsibilities

Principal Investigator (PI): Identifies, documents, and reports SAEs to sponsor within 24 hours, ensuring ISF records are updated.
Sponsor PV Team: Assesses SAE/SUSAR reports, determines causality, prepares regulatory submissions, and ensures compliance with timelines.
Regulatory Affairs (RA): Submits SUSARs and DSURs to Medsafe and HDEC.
Clinical Research Coordinator (CRC): Assists PI in safety reporting and documentation.
Quality Assurance (QA): Conducts audits of SAE/SUSAR logs and verifies adherence to privacy rules.
CRO: Provides pharmacovigilance support when delegated by sponsor.

Accountability

The sponsor’s Qualified Person for Pharmacovigilance (QPPV) is accountable for ensuring PV reporting compliance. The PI is accountable for site-level safety reporting and patient privacy adherence.

Procedure

1. SAE Identification and Initial Reporting

Document all SAEs within 24 hours of awareness using SAE Form (Annexure-1).
Notify sponsor PV team within required timeframe.
Ensure documentation in ISF.

2. SUSAR Reporting Timelines

Fatal/life-threatening SUSARs: submit to Medsafe and HDEC within 7 days, with follow-up within 8 days.
Other SUSARs: submit within 15 days.

3. ICSR and DSUR Submissions

Submit ICSRs to Medsafe’s online PV portal.
Prepare DSUR annually and submit within 60 days of data lock point.

4. Privacy Compliance

Ensure compliance with Privacy Act 2020 and HDEC privacy requirements.
De-identify subject data before reporting.
Maintain confidentiality through secure systems and restricted access.

5. Documentation and Archiving

Maintain SAE/SUSAR logs in TMF and ISF.
Archive safety data for minimum of 10 years post-trial completion.

Abbreviations

SAE: Serious Adverse Event
SUSAR: Suspected Unexpected Serious Adverse Reaction
ICSR: Individual Case Safety Report
DSUR: Development Safety Update Report
PI: Principal Investigator
CRC: Clinical Research Coordinator
PV: Pharmacovigilance
QPPV: Qualified Person for Pharmacovigilance
RA: Regulatory Affairs
QA: Quality Assurance
ISF: Investigator Site File
TMF: Trial Master File
HDEC: Health and Disability Ethics Committees

Documents

SAE Form (Annexure-1)
SUSAR Log (Annexure-2)
Privacy Compliance Checklist (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 Form

Subject ID	Event	Onset Date	Outcome	Investigator Assessment	Date Reported
NZ-301	Severe Allergic Reaction	10/08/2025	Recovered	Related	11/08/2025

Annexure-2: SUSAR Log

Date	Case ID	Event	Submitted To	Status
15/08/2025	SUSAR-305	QT Prolongation	Medsafe & HDEC	Submitted

Annexure-3: Privacy Compliance Checklist

Requirement	Compliant (Y/N)	Comments	Checked By
De-identification of subject data	Y	All identifiers removed	QA Team

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for SUSAR and SAE notifications and privacy requirements.	New SOP created for Medsafe and HDEC compliance in New Zealand.	Head of Clinical Research

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