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Standard Operating Procedure for SAE Reporting to Sponsor

Purpose

The purpose of this SOP is to establish standardized procedures for reporting serious adverse events (SAEs) to the sponsor in clinical trials. This ensures subject safety, regulatory compliance, and timely communication for expedited safety reporting obligations.

Scope

This SOP applies to investigators, study coordinators, and other authorized site personnel involved in SAE identification and reporting. It covers initial SAE notification, follow-up reporting, causality assessment, and sponsor communication requirements.

Responsibilities

• Principal Investigator (PI): Responsible for SAE assessment, initial reporting, and follow-up updates to the sponsor.
• Study Coordinator: Completes SAE reporting forms, ensures supporting documentation is submitted, and maintains ISF/TMF records.
• Sponsor/CRO: Reviews SAE reports, ensures regulatory submission within required timelines, and reconciles data with the safety database.
• Quality Assurance Officer: Audits SAE reporting records during monitoring visits and inspections.

Accountability

The PI is accountable for timely and accurate SAE reporting to the sponsor. The sponsor is accountable for ensuring further submission to regulatory authorities and global safety databases.

Procedure

1. Initial Reporting
Notify the sponsor of any SAE within 24 hours of site awareness.
Use the sponsor-provided SAE Form (Annexure-1).
Provide minimum required details: subject ID, event description, date of onset, and outcome.

2. Follow-Up Reporting
Submit follow-up information including diagnostic results, hospital records, and updated outcomes.
Update SAE Form (Annexure-1) with each follow-up.

3. Causality and Expectedness Assessment
PI assesses causality (related or unrelated) and expectedness.
Record assessment on SAE Causality Form (Annexure-2).

4. Documentation
File SAE Forms, correspondence, and acknowledgment receipts in ISF and TMF.
Maintain SAE Log (Annexure-3).

5. Reconciliation
Reconcile SAE data with sponsor’s safety database at regular intervals.
Resolve discrepancies prior to trial close-out.

6. Archiving
Archive SAE records for a minimum of 5 years post-trial or as per local regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• SAE: Serious Adverse Event
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. SAE Form (Annexure-1)
2. SAE Causality Form (Annexure-2)
3. SAE Log (Annexure-3)

References

• ICH E2A – Clinical Safety Data Management
• US FDA – Safety Reporting Requirements
• EMA – Clinical Trial Safety Reporting
• CDSCO – SAE Reporting Guidelines
• WHO – Pharmacovigilance Reporting Standards

Version: 1.0

Approval Section

Annexures

Annexure-1: SAE Form

Annexure-2: SAE Causality Form

Annexure-3: SAE Log

Revision History

For more SOPs visit: Pharma SOP