SOP for EudraVigilance SUSAR/ICSR Submissions and Follow-Ups

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“description”: “This SOP outlines the process for submitting and managing SUSARs (Suspected Unexpected Serious Adverse Reactions) and ICSRs (Individual Case Safety Reports) through EudraVigilance. It ensures compliance with EMA pharmacovigilance regulations, timelines, and follow-up obligations.”,
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Published on 25/12/2025

Standard Operating Procedure for EudraVigilance SUSAR/ICSR Submissions and Follow-Ups

SOP No.	CR/OPS/137/2025
Supersedes	NA
Page No.	1 of 78
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

Purpose

The purpose of this SOP is to establish standardized procedures for reporting and managing Suspected Unexpected Serious Adverse Reactions (SUSARs) and Individual Case Safety Reports (ICSRs) through

the European Medicines Agency’s (EMA) EudraVigilance system. This ensures compliance with EU Clinical Trials Regulation (CTR), Good Pharmacovigilance Practices (GVP), and applicable EMA guidance.

Scope

This SOP applies to sponsors, investigators, CROs, pharmacovigilance staff, and regulatory affairs personnel involved in EU clinical trials requiring SUSAR/ICSR submissions. It covers electronic submissions, timelines, MedDRA coding, follow-ups, case reconciliation, and inspection readiness.

Responsibilities

Sponsor: Ensures timely SUSAR and ICSR submissions via EudraVigilance and overall compliance with EMA regulations.
Investigator: Reports SAEs to sponsor promptly and provides follow-up data for SUSAR assessment.
CRO: Assists in preparation, validation, and electronic submission of safety reports.
Pharmacovigilance Team: Manages safety database, ensures MedDRA coding accuracy, and prepares narratives.
Regulatory Affairs: Oversees submission compliance and communicates with EMA/NCAs.
QA: Audits safety reporting workflows and ensures inspection readiness.

Accountability

The Sponsor’s Pharmacovigilance Lead is accountable for compliance with EMA SUSAR/ICSR reporting requirements. Investigators are accountable for site-level SAE reporting accuracy.

Procedure

1. SAE Identification
1.1 Investigators report SAEs to sponsor within 24 hours.
1.2 Sponsor evaluates for SUSAR criteria.
1.3 Record in SAE/SUSAR Log (Annexure-1).

2. Case Assessment
2.1 Assess seriousness, causality, and expectedness against reference safety information (RSI).
2.2 Document in SUSAR Assessment Log (Annexure-2).

3. EudraVigilance Submission
3.1 Submit fatal/life-threatening SUSARs within 7 days.
3.2 Submit other SUSARs within 15 days.
3.3 Submit all ICSRs electronically via EudraVigilance.
3.4 Record in EudraVigilance Submission Log (Annexure-3).

4. MedDRA Coding
4.1 Use latest MedDRA version for coding adverse events.
4.2 Record coding validation in MedDRA Coding Log (Annexure-4).

5. Follow-Up Reporting
5.1 Submit follow-up ICSRs with additional information within 15 days.
5.2 Document in Follow-Up Log (Annexure-5).

6. Case Reconciliation
6.1 Perform quarterly reconciliation of EudraVigilance submissions with internal safety database.
6.2 Document in Reconciliation Log (Annexure-6).

7. Inspection Readiness
7.1 Maintain inspection-ready SUSAR/ICSR records.
7.2 Conduct mock inspections documented in Inspection Readiness Log (Annexure-7).

Abbreviations

SOP: Standard Operating Procedure
SUSAR: Suspected Unexpected Serious Adverse Reaction
ICSR: Individual Case Safety Report
EMA: European Medicines Agency
CTR: Clinical Trials Regulation
CRO: Contract Research Organization
QA: Quality Assurance
MedDRA: Medical Dictionary for Regulatory Activities
RSI: Reference Safety Information

Documents

SAE/SUSAR Log (Annexure-1)
SUSAR Assessment Log (Annexure-2)
EudraVigilance Submission Log (Annexure-3)
MedDRA Coding Log (Annexure-4)
Follow-Up Log (Annexure-5)
Reconciliation Log (Annexure-6)
Inspection Readiness Log (Annexure-7)

References

Version: 1.0

Approval Section

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

Annexures

Annexure-1: SAE/SUSAR Log

Date	Subject ID	Event	Investigator	Status
01/09/2025	E101	Severe Hepatic Failure	PI	Reported

Annexure-2: SUSAR Assessment Log

Date	Event	Assessment	Reviewed By	Status
02/09/2025	Severe Hepatic Failure	Related and Unexpected	Safety Officer	Confirmed

Annexure-3: EudraVigilance Submission Log

Date	Case ID	Submitted To EMA	Submitted By	Status
03/09/2025	EV-2025-01	Yes	Reg Affairs	Accepted

Annexure-4: MedDRA Coding Log

Date	Case ID	Term	Coded By	Status
03/09/2025	EV-2025-01	Hepatic Failure	PV Specialist	Validated

Annexure-5: Follow-Up Log

Date	Case ID	Follow-Up Information	Submitted To	Status
05/09/2025	EV-2025-01	Additional Labs	EMA	Filed

Annexure-6: Reconciliation Log

Date	Database	Reconciliation Done By	Status
15/09/2025	Internal vs EudraVigilance	QA Officer	Matched

Annexure-7: Inspection Readiness Log

Date	Agency	Simulation	Performed By	Status
20/09/2025	EMA	Mock Inspection	QA Team	Completed

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head Clinical Operations

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