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Standard Operating Procedure for SAE Reporting to EC/IRB

Purpose

The purpose of this SOP is to establish procedures for reporting serious adverse events (SAEs) to Ethics Committees (EC) or Institutional Review Boards (IRB) to protect participant safety and ensure compliance with international regulations and Good Clinical Practice (GCP).

Scope

This SOP applies to all investigators and site personnel involved in SAE management and reporting to EC/IRB. It covers expedited and periodic safety reporting requirements, including timelines and follow-up documentation.

Responsibilities

• Principal Investigator (PI): Responsible for assessing SAEs and ensuring timely submission to EC/IRB.
• Study Coordinator: Completes SAE reporting forms and maintains records of EC/IRB communication.
• Sponsor/CRO: Provides templates, guidance, and oversight of SAE submissions to EC/IRB.
• Quality Assurance Officer: Ensures SAE reporting to EC/IRB is complete and compliant during audits.

Accountability

The PI is accountable for ensuring all SAEs are reported to the EC/IRB as per local and international regulations. Sponsors are accountable for verifying compliance during monitoring and close-out.

Procedure

1. Initial SAE Notification
Notify EC/IRB within 24–48 hours of awareness of an SAE, as per local regulations.
Use EC/IRB-specified forms or sponsor-approved SAE notification form (Annexure-1).

2. Follow-Up Reports
Submit follow-up information including lab tests, imaging, and clinical course to EC/IRB until event resolution.
Document updates in SAE Follow-Up Form (Annexure-2).

3. Reporting Timelines
Fatal or life-threatening SAEs: Report within 24 hours.
Other SAEs: Report within 7–15 days based on regulatory guidance.

4. Documentation
Maintain SAE submissions, acknowledgment receipts, and EC/IRB correspondence in ISF and TMF.
Record details in SAE Reporting Log (Annexure-3).

5. Reconciliation
Reconcile EC/IRB SAE reports with sponsor and site SAE logs periodically.

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

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• SAE: Serious Adverse Event
• EC: Ethics Committee
• IRB: Institutional Review Board
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. EC/IRB SAE Notification Form (Annexure-1)
2. SAE Follow-Up Form (Annexure-2)
3. SAE Reporting Log (Annexure-3)

References

• ICH E2A – Clinical Safety Data Management
• US FDA – Reporting Requirements for SAEs
• EMA – Safety Reporting Guidelines
• CDSCO – SAE Reporting to Ethics Committees
• WHO – Clinical Trial Safety and Ethics Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: EC/IRB SAE Notification Form

Annexure-2: SAE Follow-Up Form

Annexure-3: SAE Reporting Log

Revision History

For more SOPs visit: Pharma SOP