SOP for Insurance, Indemnity and ACC Considerations

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SOP for contract insurance clauses NZ, SOP for inspection readiness insurance NZ, SOP for ACC compensation NZ, SOP for cultural safety indemnity NZ, SOP for trial governance insurance NZ”,
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Published on 21/12/2025

Insurance, Indemnity and ACC Considerations SOP

Department	Clinical Research
SOP No.	CS/NZ-INS/203/2025
Supersedes	N.A.
Page No.	1 of 23
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 outline requirements for insurance, indemnity, and Accident Compensation Corporation (ACC) considerations in clinical trials conducted in New Zealand. It ensures protection of trial participants, compliance with HDEC and Medsafe expectations, and adherence to GCP standards.

Scope

This SOP applies to all clinical trials conducted in New Zealand, covering sponsor-provided insurance, indemnity agreements, site-level obligations, and ACC coverage. It applies to sponsors, investigators, CROs, regulatory staff, and QA personnel involved in trial conduct.

Responsibilities

Sponsor: Arranges insurance coverage for participants, ensures indemnity agreements are executed, and submits documentation to HDEC.
Principal Investigator (PI): Verifies insurance documents at site level and ensures participant information reflects coverage and ACC entitlements.
Regulatory Affairs (RA): Submits insurance/indemnity documentation to Medsafe and HDEC as part of ethics and regulatory approvals.
CRO: Supports sponsor in managing insurance and indemnity obligations when delegated.
Quality Assurance (QA): Audits insurance documentation and indemnity agreements for compliance.

Accountability

The sponsor’s Head of Clinical Operations is accountable for ensuring adequate insurance and indemnity provisions. The PI is accountable for ensuring site compliance with ACC and trial subject coverage requirements.

Procedure

1. Insurance Coverage

Sponsor must arrange clinical trial insurance covering injury or harm related to participation.
Maintain insurance certificates in TMF and ISF.
Ensure coverage complies with HDEC requirements and New Zealand law.

2. Indemnity Agreements

Draft and execute indemnity agreements with investigators and sites.
Submit copies to HDEC with trial application.

3. ACC Considerations

Ensure trial participants are informed of their rights under ACC coverage.
Document ACC provisions in Participant Information Sheet (PIS) and Informed Consent Form (ICF).

4. Documentation and Submission

Maintain Insurance Documentation Log (Annexure-1).
Submit insurance and indemnity documents as part of ethics and regulatory submissions.

5. Audits and Inspections

QA must audit insurance and indemnity records annually.
Maintain inspection readiness with complete and current documentation.

Abbreviations

HDEC: Health and Disability Ethics Committees
Medsafe: New Zealand Medicines and Medical Devices Safety Authority
ACC: Accident Compensation Corporation
PI: Principal Investigator
RA: Regulatory Affairs
QA: Quality Assurance
CRO: Contract Research Organization
PIS: Patient Information Sheet
ICF: Informed Consent Form
TMF: Trial Master File
ISF: Investigator Site File

Documents

Insurance Documentation Log (Annexure-1)
Indemnity Agreement Log (Annexure-2)
ACC Disclosure Form (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: Insurance Documentation Log

Date	Policy No.	Coverage	Insurer	Status
05/08/2025	INS-2025-45	Participant Injury	NZ Health Insurers Ltd.	Valid

Annexure-2: Indemnity Agreement Log

Date	Site	Agreement Executed	Signed By
08/08/2025	Auckland Clinical Centre	Yes	Dr. Anita Patel

Annexure-3: ACC Disclosure Form

Subject ID	Disclosure Provided	Date	Signature
NZ-401	Yes	12/08/2025	__________

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for insurance, indemnity, and ACC considerations in New Zealand trials.	New SOP created for Medsafe, HDEC, and ACC compliance.	Head of Clinical Research

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