compliance safety NZ, SOP for CAPA safety findings NZ, SOP for ethics safety compliance NZ, SOP for trial oversight safety reporting NZ, SOP for GCP safety compliance NZ, SOP for pharmacovigilance audits NZ”,
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Published on 25/12/2025

Clinical Trial Safety Reporting and Pharmacovigilance SOP

Department	Clinical Research
SOP No.	CS/NZ-SAF/208/2025
Supersedes	N.A.
Page No.	1 of 28
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to establish processes for safety reporting and pharmacovigilance in clinical trials conducted in New Zealand. It ensures compliance with Medsafe, HDEC, and ICH GCP requirements to protect participant safety and ensure regulatory reporting obligations are met.

Scope

This SOP applies to all sponsor-led and investigator-initiated clinical trials in New Zealand. It covers SAE/SUSAR reporting, ICSR submissions, DSUR reporting, expedited safety notifications, safety database management, and PV audits. It applies to sponsors, investigators, CROs, PV officers, and QA teams.

Responsibilities

• Sponsor: Oversees pharmacovigilance systems, ensures timely safety reporting, and submits DSURs to Medsafe/HDEC.
• Principal Investigator (PI): Identifies, documents, and reports SAEs within 24 hours, and ensures site-level reporting compliance.
• Clinical Research Coordinator (CRC): Supports PI in safety reporting, documentation, and follow-up.
• Regulatory Affairs (RA): Manages submissions to Medsafe/HDEC, ensures acknowledgment of SUSAR/SAE reports.
• PV Officer: Maintains safety database and prepares ICSRs/DSURs.
• Quality Assurance (QA): Conducts pharmacovigilance audits and ensures corrective actions are implemented.
• CRO: Provides pharmacovigilance support when delegated by sponsor.

Accountability

The sponsor’s Qualified Person for Pharmacovigilance (QPPV) is accountable for ensuring compliance with PV requirements. The PI is accountable for site-level safety reporting accuracy and timeliness.

Procedure

1. SAE Reporting

1. Document all SAEs in SAE Form (Annexure-1) within 24 hours of awareness.
2. Notify sponsor PV team immediately for evaluation.
3. Retain records in ISF and TMF.

2. SUSAR Reporting

1. Fatal or life-threatening SUSARs: report to Medsafe/HDEC within 7 calendar days; provide follow-up within 8 days.
2. Other SUSARs: submit within 15 calendar days.
3. Record all SUSARs in SUSAR Log (Annexure-2).

3. ICSR Submissions

1. Prepare ICSRs in compliance with Medsafe requirements.
2. Submit electronically via approved PV system.

4. DSUR Submissions

1. Prepare DSUR annually, summarizing safety data across all regions.
2. Submit to Medsafe within 60 days of data lock point.

5. Privacy and Confidentiality

1. De-identify participant data before submissions.
2. Ensure compliance with Privacy Act 2020.

6. Pharmacovigilance Audits

1. QA team conducts annual PV audits.
2. Maintain CAPA for identified findings in PV Audit Log (Annexure-3).

7. Archiving

1. Archive SAE, SUSAR, ICSR, and DSUR records in TMF and ISF.
2. Maintain records for at least 10 years post-trial.

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
• Medsafe: Medicines and Medical Devices Safety Authority

Documents

1. SAE Form (Annexure-1)
2. SUSAR Log (Annexure-2)
3. PV Audit Log (Annexure-3)

References

• Medsafe — Medicines and Medical Devices Safety Authority
• HDEC — Health and Disability Ethics Committees
• New Zealand Privacy Act 2020
• ICH E6(R2) Good Clinical Practice
• ICH E2F — DSUR Guidelines

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-601	Severe Allergic Reaction	05/08/2025	Recovered	Related	06/08/2025

Annexure-2: SUSAR Log

Date	Case ID	Event	Submitted To	Status
10/08/2025	SUSAR-401	QT Prolongation	Medsafe & HDEC	Submitted

Annexure-3: PV Audit Log

Date	Audit Area	Findings	CAPA	Auditor
20/08/2025	PV Database	Two delayed SUSAR submissions	Staff retrained; system updated	Neha Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for safety reporting and pharmacovigilance in New Zealand clinical trials.	New SOP created for Medsafe, HDEC, and ICH GCP compliance.	Head of Clinical Research

For more SOPs visit: Pharma SOP.