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“headline”: “SOP for SUSAR/SAE Reporting to UK Authority (Country-Specific Pathways)”,
“description”: “This SOP outlines the procedures for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) and Serious Adverse Events (SAEs) to the MHRA in compliance with UK country-specific requirements. It ensures timely reporting, regulatory compliance, and subject safety monitoring.”,
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Standard Operating Procedure for SUSAR/SAE Reporting to UK Authority (Country-Specific Pathways)

Purpose

The purpose of this SOP is to describe the process for reporting Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) to the Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with UK country-specific requirements. This ensures patient safety, compliance with Good Clinical Practice (GCP), and adherence to expedited reporting timelines.

Scope

This SOP applies to sponsors, CROs, investigators, pharmacovigilance (PV) staff, and regulatory affairs teams responsible for safety data management in clinical trials conducted in the UK. It covers SAE documentation, SUSAR detection, expedited reporting, and submission through MHRA electronic pathways.

Responsibilities

• Sponsor: Ensures SUSAR and SAE reports are submitted to MHRA within required timelines.
• CRO: Supports safety data collection, SAE follow-up, and submissions to MHRA.
• Investigator: Identifies, documents, and reports SAEs/SUSARs promptly to the sponsor.
• PV Department: Prepares, validates, and submits electronic safety reports to MHRA.
• QA: Audits safety reporting processes for UK regulatory compliance.

Accountability

The Sponsor’s Head of Pharmacovigilance is accountable for ensuring all SAE and SUSAR reporting complies with MHRA requirements and UK-specific timelines.

Procedure

1. SAE Reporting
1.1 Investigators must record all SAEs in source documents and CRFs.
1.2 SAEs must be reported to the sponsor within 24 hours of awareness.
1.3 Record in SAE Reporting Log (Annexure-1).

2. SUSAR Identification
2.1 PV team evaluates reported SAEs to determine causality and expectedness.
2.2 Confirmed SUSARs must be prepared for expedited reporting.
2.3 Record in SUSAR Identification Log (Annexure-2).

3. Reporting to MHRA
3.1 Submit SUSARs electronically to MHRA via EudraVigilance MHRA Gateway or national system.
3.2 Fatal or life-threatening SUSARs: report within 7 days (follow-up within 8 additional days).
3.3 All other SUSARs: report within 15 days.
3.4 Document in MHRA Reporting Log (Annexure-3).

4. Communication with Ethics Committees
4.1 SUSARs must also be submitted to UK Research Ethics Committees as required.
4.2 Record submissions in EC Reporting Log (Annexure-4).

5. Archiving
5.1 File all SAE/SUSAR documentation and MHRA submissions in the TMF.
5.2 Record archiving in Safety Archiving Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• MHRA: Medicines and Healthcare products Regulatory Agency
• PV: Pharmacovigilance
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• EC: Ethics Committee
• CRF: Case Report Form

Documents

1. SAE Reporting Log (Annexure-1)
2. SUSAR Identification Log (Annexure-2)
3. MHRA Reporting Log (Annexure-3)
4. EC Reporting Log (Annexure-4)
5. Safety Archiving Log (Annexure-5)

References

• MHRA Guidance – Safety Reporting in Clinical Trials
• ICH GCP Guidelines
• UK Guidance on Pharmacovigilance

Version: 1.0

Approval Section

Annexures

Annexure-1: SAE Reporting Log

Annexure-2: SUSAR Identification Log

Annexure-3: MHRA Reporting Log

Annexure-4: EC Reporting Log

Annexure-5: Safety Archiving Log

Revision History

For more SOPs visit: Pharma SOP