SOP for SUSAR/SAE Reporting to UK Authority (Country-Specific Pathways)

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“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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Published on 21/12/2025

Standard Operating Procedure for SUSAR/SAE Reporting to UK Authority (Country-Specific Pathways)

SOP No.	CR/OPS/161/2025
Supersedes	NA
Page No.	X of Y
Issue Date	27/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

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

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

References

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, PV Specialist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Pharmacovigilance

Annexures

Annexure-1: SAE Reporting Log

Date	Subject ID	Event	Reported By	Status
01/09/2025	SUB-801	Hospitalization – Pneumonia	Investigator	Submitted

Annexure-2: SUSAR Identification Log

Date	SAE ID	SUSAR Determination	Assessed By	Status
02/09/2025	SAE-2025-01	SUSAR – Unexpected Severity	PV Specialist	Confirmed

Annexure-3: MHRA Reporting Log

Date	SUSAR ID	Submitted To	Submitted By	Status
03/09/2025	SUSAR-2025-01	MHRA Gateway	PV Specialist	Submitted

Annexure-4: EC Reporting Log

Date	SUSAR ID	Submitted To	By	Status
04/09/2025	SUSAR-2025-01	REC London	Reg Affairs	Completed

Annexure-5: Safety Archiving Log

Date	Document Type	Archived By	Location	Status
10/09/2025	SUSAR-2025-01 Submission	QA	TMF	Archived

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
27/08/2025	00	Initial version	New SOP creation	Head Pharmacovigilance

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