SOP for Insurance and Indemnity Requirements

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Published on 22/12/2025

Insurance and Indemnity Requirements SOP

Department	Clinical Research
SOP No.	CS/TGA-INS/176/2025
Supersedes	N.A.
Page No.	1 of 20
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 establish requirements for insurance and indemnity in clinical trials conducted under the CTN/CTX schemes in Australia. It ensures sponsor, site, and investigator compliance with TGA, Human Research Ethics Committee (HREC), and institutional governance requirements to safeguard participant rights and provide indemnity coverage for clinical trial-related injuries.

Scope

This SOP applies to all clinical trials sponsored or managed by the organization in Australia requiring insurance and indemnity arrangements. It covers sponsor obligations for trial insurance, indemnity agreements with investigators and sites, documentation requirements, and institutional governance compliance. It also applies to multi-site trials requiring SSA documentation of insurance arrangements.

Responsibilities

Sponsor: Secures insurance policy covering trial participants for injury or harm related to investigational products and trial procedures.
Principal Investigator (PI): Ensures site staff are informed of indemnity arrangements and provides indemnity certificates to site governance offices.
Regulatory Affairs (RA): Confirms insurance documents are filed with CTN/CTX submissions and SSA applications.
Clinical Project Manager (CPM): Coordinates insurance certificates for each site and maintains tracking logs.
Quality Assurance (QA): Audits insurance and indemnity records for inspection readiness.

Accountability

The Sponsor is accountable for ensuring valid insurance and indemnity coverage throughout the trial duration. The Head of Clinical Research is accountable for maintaining oversight of insurance arrangements across all trials.

Procedure

1. Insurance Policy Requirements

Obtain trial insurance policy covering clinical trial liability, participant compensation, and investigator indemnity.
Ensure policy meets Australian law and HREC requirements.
Maintain policy validity throughout the study with no lapses in coverage.

2. Indemnity Agreements

Prepare indemnity agreements for investigators and institutions using Medicines Australia Standard Indemnity templates.
Ensure indemnity agreements are executed before trial initiation at each site.
File signed agreements in TMF and ISF.

3. Documentation for Ethics and Governance

Submit copies of insurance policies and indemnity agreements with HREC and SSA applications.
Record acknowledgments and approvals in Insurance Documentation Log.

4. Monitoring and Renewals

Monitor policy expiry dates and renew coverage before lapse.
Update insurance certificates for protocol amendments or trial extensions.

5. Archiving

Archive insurance and indemnity documents for a minimum of 15 years or as per institutional requirements.

Abbreviations

CTN: Clinical Trial Notification
CTX: Clinical Trial Exemption
TGA: Therapeutic Goods Administration
HREC: Human Research Ethics Committee
SSA: Site-Specific Assessment
PI: Principal Investigator
CPM: Clinical Project Manager
RA: Regulatory Affairs
QA: Quality Assurance
TMF: Trial Master File
ISF: Investigator Site File

Documents

Insurance Documentation Log (Annexure-1)
Indemnity Agreement Template (Annexure-2)
Insurance Certificate Tracker (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 Type	Expiry Date	Status	Owner
05/08/2025	POL-2025-01	Clinical Trial Liability	05/08/2026	Active	Rajesh Kumar

Annexure-2: Indemnity Agreement Template

Institution	Investigator	Agreement Type	Date Signed
Melbourne General Hospital	Dr. Sarah Lee	Medicines Australia Standard Indemnity	10/08/2025

Annexure-3: Insurance Certificate Tracker

Site	Certificate No.	Issued Date	Expiry Date	Status
Sydney Clinical Centre	IC-2025-07	12/08/2025	12/08/2026	Valid

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for insurance and indemnity requirements.	New SOP created for compliance with TGA CTN/CTX governance.	Head of Clinical Research

For more SOPs visit: Pharma SOP.