SOP for SUSAR Reporting to Appropriate Authorities/Portals

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Published on 21/12/2025

Standard Operating Procedure for SUSAR Reporting to Authorities and Portals

Department	Clinical Research
SOP No.	CR/SAE/044/2025
Supersedes	NA
Page No.	1 of 22
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 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

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

References

Version: 1.0

Approval Section

Prepared By	Rajesh Kumar, Clinical Research Associate
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Principal Investigator

Annexures

Annexure-1: SUSAR Submission Log

Date	Subject ID	Event	Regulatory Authority	Submission Date	Acknowledgment
12/09/2025	CT2025-SITE01-111	Unexpected anaphylaxis	EMA	13/09/2025	Yes

Annexure-2: SUSAR Case Report Template

Subject ID	Event Description	Date of Onset	Causality	Expectedness	Outcome
CT2025-SITE01-111	Unexpected anaphylaxis	12/09/2025	Related	Unexpected	Recovered

Annexure-3: Regulatory Acknowledgment Record

Date	Regulatory Authority	Acknowledgment No.	Verified By
13/09/2025	EMA	EV-2025-9987	QA Officer

Revision History

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

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