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“headline”: “SOP for SUSAR Reporting to Regulatory Authorities and Portals in Clinical Trials”,
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Standard Operating Procedure for SUSAR Reporting to Authorities and Portals

Purpose

The purpose of this SOP is to provide standardized procedures for the reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory authorities and designated portals. It ensures expedited safety communication and regulatory compliance globally.

Scope

This SOP applies to sponsors, investigators, and CROs responsible for safety reporting in clinical trials. It covers initial SUSAR detection, expedited submission to regulatory authorities, follow-up reports, and reconciliation of SUSAR data across systems.

Responsibilities

• Principal Investigator (PI): Identifies potential SUSARs and reports to sponsor within required timelines.
• Sponsor/CRO: Submits SUSARs to regulatory authorities via appropriate portals such as FDA Safety Reporting Portal, EMA EudraVigilance, and CDSCO SUGAM.
• Regulatory Affairs Department: Ensures compliance with reporting timelines and maintains submission records.
• QA Officer: Verifies completeness and compliance of SUSAR reports during audits and inspections.

Accountability

The sponsor is accountable for regulatory SUSAR submissions, while the PI remains accountable for initial identification and timely reporting to the sponsor.

Procedure

1. Identification of SUSAR
Investigators assess seriousness, unexpectedness, and causality.
Report suspected SUSARs to sponsor within 24 hours.

2. Reporting Timelines
Fatal or life-threatening SUSARs: Submit to regulatory authority within 7 calendar days.
All other SUSARs: Submit within 15 calendar days.

3. Submission Process
Prepare Case Safety Report in ICH E2B(R3) format.
Submit electronically via FDA Safety Reporting Portal, EMA EudraVigilance, or CDSCO SUGAM.
Maintain regulatory acknowledgment receipts.

4. Follow-Up Reports
Update regulatory authorities with follow-up data (clinical outcome, lab results).
Maintain audit trail of all submissions.

5. Documentation
Record SUSARs in SUSAR Submission Log (Annexure-1).
File all submission receipts in ISF and TMF.

6. Reconciliation
Periodically reconcile SUSARs reported at site, sponsor database, and regulatory systems.

7. Archiving
Retain SUSAR records for minimum 5 years post-trial or as per applicable regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• CRO: Clinical Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• FDA: Food and Drug Administration
• EMA: European Medicines Agency
• CDSCO: Central Drugs Standard Control Organization

Documents

1. SUSAR Submission Log (Annexure-1)
2. SUSAR Case Report Template (Annexure-2)
3. Regulatory Acknowledgment Record (Annexure-3)

References

• ICH E2A – Clinical Safety Data Management
• US FDA – SUSAR and Safety Reporting
• EMA – EudraVigilance SUSAR Reporting
• CDSCO – SUSAR Reporting Guidelines
• WHO – International Pharmacovigilance Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: SUSAR Submission Log

Annexure-2: SUSAR Case Report Template

Annexure-3: Regulatory Acknowledgment Record

Revision History

For more SOPs visit: Pharma SOP