Standard Operating Procedure for Clinical Trial Insurance for BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/014/2025 |
| Supersedes | SOP/BA-BE/014/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a standard procedure for obtaining and managing clinical trial insurance coverage to safeguard the rights and well-being of study participants and to meet national and international regulatory requirements for conducting BA/BE studies.
2. Scope
This SOP is applicable to all BA/BE clinical trials conducted by or on behalf of the sponsor and covers activities related to procuring, verifying, renewing, and documenting insurance coverage for study subjects in India and globally.
3. Responsibilities
- Regulatory Affairs: Identifies insurance requirements based on country-specific regulations.
- Clinical Project Manager: Coordinates insurance procurement with approved vendors and ensures inclusion in submission dossiers.
- Legal/Contracts Department: Reviews policy terms, liability clauses, and indemnity provisions.
- Quality Assurance: Verifies insurance compliance during audits and maintains documentation.
4. Accountability
The Head of Clinical Operations is accountable for ensuring that valid and appropriate clinical trial insurance coverage is in place before study initiation and remains valid throughout the trial period.
5. Procedure
5.1 Identification of Insurance Requirement
- Determine the requirement for trial insurance based on:
- Country of study conduct (e.g., mandatory under Schedule Y in India)
- Sponsor policies and ethics committee expectations
- Document requirement justification in Annexure-1: Insurance Requirement Checklist.
5.2 Selection of Insurance Provider
- Select insurance providers with:
- IRDA registration (for India) or local authority approval (international)
- Prior experience with clinical trials
- Review sample policies and terms via the Legal department.
5.3 Preparation of Insurance Brief
- Prepare trial summary for insurer including:
- Study title and protocol number
- Sites and number of participants
- Study duration
- Dosage/formulation details
- Phase of trial (BA/BE)
- Share details with shortlisted insurance providers for quotation.
5.4 Review and Finalization of Policy
- Review policy for:
- Coverage limit per participant
- Total trial coverage
- Medical and legal liability
- Geographic coverage
- Validity period
- Sign agreement and obtain original policy certificate.
5.5 Distribution and Archival
- Distribute policy copies to:
- Ethics Committee (as part of submission)
- Investigational sites
- Sponsor’s Regulatory Affairs and Clinical Operations
- Archive scanned and hard copies in the eTMF and insurance file log (Annexure-2).
5.6 Insurance Renewal and Closure
- Monitor policy expiry and renew if study extends beyond original validity.
- Upon trial close-out, notify insurer of completion and obtain no-claim declaration, if required.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- IRDA: Insurance Regulatory and Development Authority
- eTMF: Electronic Trial Master File
- SOP: Standard Operating Procedure
7. Documents
- Insurance Requirement Checklist – Annexure-1
- Clinical Trial Insurance Log – Annexure-2
- Policy Review Form – Annexure-3
8. References
- Schedule Y – Drugs and Cosmetics Rules, India
- ICH E6 (R2) – Good Clinical Practice
- USFDA IND Safety Reporting Guidance
- EMA Clinical Trial Insurance Requirements
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Insurance Requirement Checklist
| Study Title | Region | Insurance Required | Remarks |
|---|---|---|---|
| XYZ BA/BE Study | India | Yes | Mandatory per Schedule Y |
Annexure-2: Clinical Trial Insurance Log
| Policy No. | Valid From | Valid To | Study Title | Provider | Status |
|---|---|---|---|---|---|
| INS12345 | 15/04/2025 | 14/04/2026 | ABC BA/BE Trial | LifeSecure India | Active |
Annexure-3: Policy Review Form
| Reviewer | Date | Key Findings | Action Taken |
|---|---|---|---|
| Sunita Reddy | 10/04/2025 | Coverage verified for 100 subjects | Policy finalized |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial release | New Document | QA Head |
| 17/04/2025 | 2.0 | Expanded to cover global practices and added annexures | Audit readiness | QA Head |