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Standard Operating Procedure for SAE Compensation Assessment, Payment, and Reporting Timelines

Purpose

The purpose of this SOP is to define procedures for the assessment, payment, and reporting of Serious Adverse Event (SAE) compensation in clinical trials conducted in India. It ensures compliance with the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), and New Drugs and Clinical Trials Rules (NDCTR), 2019. The SOP safeguards participant rights and ensures transparency in compensation timelines.

Scope

This SOP applies to sponsors, CROs, investigators, and ethics committees involved in clinical trials conducted in India where SAEs result in trial-related injury or death. It covers SAE assessment, compensation calculation, payment timelines, reporting to DCGI and ethics committees, and documentation.

Responsibilities

• Sponsor: Assesses SAE compensation liability, arranges for timely payment, and reports to DCGI/EC.
• Investigator: Reports SAEs within 24 hours, provides required medical documentation, and supports compensation process.
• CRO: Coordinates assessment and reporting on behalf of sponsor.
• EC: Reviews SAE assessment reports and approves compensation decisions.
• QA: Audits SAE reporting and payment records for compliance.

Accountability

The Sponsor’s Medical and Regulatory Affairs Head is accountable for timely SAE compensation assessment, disbursement, and regulatory reporting compliance.

Procedure

1. SAE Reporting
1.1 Investigator reports SAE to sponsor, EC, and DCGI within 24 hours.
1.2 Document in SAE Initial Report Log (Annexure-1).

2. Causality Assessment
2.1 Sponsor’s Independent Expert Committee conducts causality assessment within 30 days.
2.2 Record decision in SAE Causality Assessment Log (Annexure-2).

3. Compensation Calculation
3.1 Compensation calculated as per DCGI formula (NDCTR, 2019).
3.2 Record calculation details in Compensation Calculation Log (Annexure-3).

4. EC Review
4.1 Submit assessment and proposed compensation to Ethics Committee for approval.
4.2 Document review outcome in EC Review Log (Annexure-4).

5. Payment Execution
5.1 Disburse compensation within 30 days of EC/DCGI approval.
5.2 Record transaction in Compensation Payment Log (Annexure-5).

6. Reporting Timelines
6.1 Final compensation report submitted to DCGI and EC within 45 days of SAE reporting.
6.2 Archive all reports in TMF and ISF.

Abbreviations

• SOP: Standard Operating Procedure
• SAE: Serious Adverse Event
• EC: Ethics Committee
• DCGI: Drugs Controller General of India
• CDSCO: Central Drugs Standard Control Organization
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• NDCTR: New Drugs and Clinical Trials Rules

Documents

1. SAE Initial Report Log (Annexure-1)
2. SAE Causality Assessment Log (Annexure-2)
3. Compensation Calculation Log (Annexure-3)
4. EC Review Log (Annexure-4)
5. Compensation Payment Log (Annexure-5)

References

• CDSCO – Central Drugs Standard Control Organization
• New Drugs and Clinical Trials Rules, 2019
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: SAE Initial Report Log

Annexure-2: SAE Causality Assessment Log

Annexure-3: Compensation Calculation Log

Annexure-4: EC Review Log

Annexure-5: Compensation Payment Log

Revision History

For more SOPs visit: Pharma SOP