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Local SUSAR and SAE Notifications and Privacy Requirements SOP

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

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

2. SUSAR Reporting Timelines

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

3. ICSR and DSUR Submissions

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

4. Privacy Compliance

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

5. Documentation and Archiving

1. Maintain SAE/SUSAR logs in TMF and ISF.
2. 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

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

References

• Medsafe — Clinical Trial Safety Reporting
• Health and Disability Ethics Committees (HDEC)
• New Zealand Privacy Act 2020
• ICH E6(R2) Good Clinical Practice

Version: 1.0

Approval

Annexures

Annexure-1: SAE Form

Annexure-2: SUSAR Log

Annexure-3: Privacy Compliance Checklist

Revision History

For more SOPs visit: Pharma SOP.

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HDEC Ethics Submissions and Conditions of Approval SOP

Purpose

The purpose of this SOP is to define the process for preparing, submitting, and managing Health and Disability Ethics Committee (HDEC) submissions in New Zealand. It ensures compliance with New Zealand ethical standards, GCP requirements, and specific HDEC conditions of approval.

Scope

This SOP applies to all sponsor-led and investigator-initiated clinical trials requiring HDEC approval in New Zealand. It covers initial submissions, amendments, reporting obligations, and compliance with approval conditions. It is applicable to sponsors, investigators, CROs, regulatory affairs, and quality teams involved in New Zealand-based studies.

Responsibilities

• Sponsor: Ensures completeness of submission packages, manages communications with HDEC, and complies with conditions of approval.
• Principal Investigator (PI): Provides site-level documentation, ensures informed consent processes meet HDEC expectations, and maintains ISF accordingly.
• Regulatory Affairs (RA): Submits initial and amended documents to HDEC via online systems, and ensures timely responses to queries.
• CRO: Supports sponsor with preparation of submissions and communication with HDEC when delegated.
• Quality Assurance (QA): Audits submissions and documentation for compliance and readiness for inspection.

Accountability

The sponsor’s Head of Regulatory Affairs is accountable for ensuring adherence to HDEC submission procedures. The PI is accountable for site-level compliance with conditions of approval.

Procedure

1. Initial Submission

1. Prepare documents: protocol, Investigator’s Brochure, ICF, PIS, CVs, and other required attachments.
2. Submit through the HDEC Online Submission System.
3. Record submission details in Submission Log (Annexure-1).

2. Review and Queries

1. Respond to HDEC queries within stipulated timelines.
2. Submit revised documents where requested.

3. Conditions of Approval

1. Review HDEC approval letter for specific conditions.
2. Ensure timely reporting of protocol deviations, amendments, and safety updates.
3. Maintain a Conditions of Approval Log (Annexure-2).

4. Amendments

1. Prepare amendment packages including updated protocols or consent forms.
2. Submit amendments via HDEC online system.

5. Reporting Obligations

1. Submit annual progress reports to HDEC.
2. Submit safety reports including SAEs and SUSARs as per HDEC guidelines.
3. Submit final report upon trial completion.

6. Archiving

1. Archive submission documents, communications, and approvals in TMF and ISF.
2. Maintain records for minimum 10 years after trial completion.

Abbreviations

• HDEC: Health and Disability Ethics Committee
• MFDS: Ministry of Food and Drug Safety
• PIS: Patient Information Sheet
• ISF: Investigator Site File
• TMF: Trial Master File
• RA: Regulatory Affairs
• QA: Quality Assurance
• PI: Principal Investigator
• CRO: Contract Research Organization

Documents

1. Submission Log (Annexure-1)
2. Conditions of Approval Log (Annexure-2)
3. Amendment Log (Annexure-3)

References

• New Zealand Health and Disability Ethics Committees (HDEC)
• ICH E6(R2) Good Clinical Practice
• WHO Clinical Trials Guidelines

Version: 1.0

Approval

Annexures

Annexure-1: Submission Log

Annexure-2: Conditions of Approval Log

Annexure-3: Amendment Log

Revision History

For more SOPs visit: Pharma SOP.