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Published on 21/12/2025

SUSAR and SAE Reporting via National Systems SOP

Department	Clinical Research
SOP No.	CS/ANVISA-SAF/182/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to establish standardized processes for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) and Serious Adverse Events (SAEs) through Brazil’s national pharmacovigilance systems (e.g., Notivisa). It ensures timely compliance with ANVISA’s regulatory requirements, maintaining patient safety and data integrity.

Scope

This SOP applies to all clinical trials sponsored or managed by the organization in Brazil under ANVISA oversight. It covers expedited SUSAR reporting, SAE submissions, data entry into Notivisa, narrative preparation, Development Safety Update Report (DSUR) submissions, and responsibilities of sponsors, investigators, and CROs.

Responsibilities

• Principal Investigator (PI): Identifies and reports SAEs to the sponsor within 24 hours, maintains source documentation, and ensures SAE forms are complete.
• Clinical Research Coordinator (CRC): Supports SAE reporting and ensures site documentation is filed in the Investigator Site File (ISF).
• Pharmacovigilance (PV) Team: Performs medical assessment, prepares SUSAR narratives, and submits cases into Notivisa.
• Regulatory Affairs (RA): Confirms case acknowledgments from ANVISA and ensures DSURs are submitted on time.
• Quality Assurance (QA): Audits SAE and SUSAR processes, ensuring compliance with Brazilian law and inspection readiness.

Accountability

The Sponsor’s Qualified Person for Pharmacovigilance (QPPV) in Brazil is accountable for ensuring timely and accurate SUSAR and SAE submissions to ANVISA. The Head of Clinical Research is accountable for overall compliance oversight.

Procedure

1. Identification and Initial Reporting

1. Investigators document SAEs in the SAE Report Form immediately upon awareness.
2. Forward SAE reports to the sponsor within 24 hours for evaluation.
3. Ensure medical records and source data are included for causality and expectedness assessment.

2. SUSAR Reporting Timelines

1. Fatal or life-threatening SUSARs: submit to Notivisa within 7 calendar days, with follow-up within 8 days.
2. Other SUSARs: submit within 15 calendar days.

3. Data Entry into Notivisa

1. PV team enters SUSAR and SAE cases into Notivisa using secure login credentials.
2. Ensure all mandatory fields are completed, including narrative, laboratory data, and outcome.
3. Generate acknowledgment receipt and file in Trial Master File (TMF).

4. DSUR Submissions

1. Prepare annual DSUR with cumulative safety data.
2. Submit DSUR to ANVISA within 60 days of data lock point.
3. Maintain DSUR Tracker in TMF.

5. Privacy and Data Protection

1. Ensure SAE/SUSAR reports exclude direct subject identifiers before submission.
2. Use anonymized trial subject IDs for regulatory submissions.

6. Archiving

1. Maintain SAE and SUSAR logs, acknowledgment receipts, and DSURs in TMF and ISF.
2. Archive documents for a minimum of 15 years or as per ANVISA requirements.

Abbreviations

• ANVISA: Agência Nacional de Vigilância Sanitária
• CONEP: Comissão Nacional de Ética em Pesquisa
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• DSUR: Development Safety Update Report
• PV: Pharmacovigilance
• QPPV: Qualified Person for Pharmacovigilance
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. SAE Report Form (Annexure-1)
2. SUSAR Submission Log (Annexure-2)
3. DSUR Tracker (Annexure-3)

References

• ANVISA — Clinical Trials and Pharmacovigilance
• ANVISA Notivisa System
• ICH E6(R2) Good Clinical Practice
• ICH E2A: Clinical Safety Data Management
• ICH E2F: Development Safety Update Report

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: SAE Report Form

Subject ID	Event	Onset Date	Outcome	Investigator Assessment	Date Reported
BRA-101	Severe Hepatic Injury	10/08/2025	Ongoing	Possibly Related	11/08/2025

Annexure-2: SUSAR Submission Log

Case ID	Subject ID	Event	Report Type	Date Submitted	Acknowledgment
SUS-501	BRA-102	Seizure	7-day Expedited	15/08/2025	Received

Annexure-3: DSUR Tracker

Protocol No.	DSUR Period	Submission Date	Status	Owner
BRA-2025-01	01/08/2024 – 31/07/2025	15/09/2025	Submitted	Neha Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for SUSAR and SAE reporting via Notivisa and national systems.	New SOP created for compliance with ANVISA pharmacovigilance requirements.	Head of Clinical Research

For more SOPs visit: Pharma SOP.