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Standard Operating Procedure for SAE Identification and Documentation

Purpose

The purpose of this SOP is to define standardized procedures for the identification, classification, and documentation of serious adverse events (SAEs) during clinical trials. This ensures subject safety, accurate reporting, and compliance with applicable regulatory frameworks.

Scope

This SOP applies to investigators, study staff, sponsors, and CROs engaged in clinical trials where SAEs may occur. It covers SAE identification, seriousness assessment, causality evaluation, documentation, and reconciliation with safety databases.

Responsibilities

• Principal Investigator (PI): Responsible for assessing seriousness, causality, and documenting all SAEs accurately and promptly.
• Study Coordinator: Collects SAE data, completes SAE forms, and ensures timely entry into the database.
• Sponsor/CRO: Reviews SAE reports, ensures regulatory reporting timelines are met, and reconciles with global safety database.
• Quality Assurance Officer: Reviews SAE logs and documentation during monitoring visits and audits.

Accountability

The PI is accountable for ensuring all SAEs are correctly identified and documented within protocol-defined timelines. Sponsors are accountable for oversight and ensuring regulatory submissions are completed as required.

Procedure

1. Identification of SAEs
Train all staff on definitions of SAEs per ICH GCP and protocol.
Promptly identify any event meeting seriousness criteria (e.g., death, life-threatening event, hospitalization, disability, congenital anomaly).

2. Initial Documentation
Record SAE details immediately in the source document and SAE Form (Annexure-1).
Include subject ID, event description, date of onset, outcome, and treatment given.

3. Assessment
PI assesses seriousness, causality (related or unrelated to IP), and expectedness.
Classify SAE according to protocol and regulatory guidelines.

4. Follow-Up Documentation
Update SAE form with follow-up data (lab results, imaging, clinical course).
File updated SAE forms in ISF and TMF.

5. Reconciliation
Reconcile site SAE records with sponsor’s safety database periodically.
Resolve discrepancies in consultation with QA.

6. Archiving
Archive SAE records, including narratives, case files, and correspondence, for minimum 5 years post-trial or as per regulatory requirements.

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 Log (Annexure-2)
3. SAE Reconciliation Report (Annexure-3)

References

• ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• US FDA – Safety Reporting Requirements
• EMA – Clinical Trial Safety Reporting
• CDSCO – Clinical Trial Safety and SAE Rules
• WHO – Pharmacovigilance Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: SAE Form

Annexure-2: SAE Log

Annexure-3: SAE Reconciliation Report

Revision History

For more SOPs visit: Pharma SOP