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“headline”: “SOP for EudraVigilance SUSAR/ICSR Submissions and Follow-Ups”,
“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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Standard Operating Procedure for EudraVigilance SUSAR/ICSR Submissions and Follow-Ups

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

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

References

• EMA – EudraVigilance
• EU Clinical Trials Regulation (EU CTR 536/2014)
• ICH E2A/E2F Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: SAE/SUSAR Log

Annexure-2: SUSAR Assessment Log

Annexure-3: EudraVigilance Submission Log

Annexure-4: MedDRA Coding Log

Annexure-5: Follow-Up Log

Annexure-6: Reconciliation Log

Annexure-7: Inspection Readiness Log

Revision History

For more SOPs visit: Pharma SOP