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Published on 25/12/2025

Local Pharmacovigilance and ICSR Submission Pathways SOP

Department	Clinical Research
SOP No.	CS/SAHPRA-PV/188/2025
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 procedures for local pharmacovigilance (PV) reporting and Individual Case Safety Report (ICSR) submissions in South Africa. It ensures compliance with SAHPRA requirements for safety reporting in clinical trials, safeguarding subject safety and maintaining trial integrity.

Scope

This SOP applies to all sponsor-led and investigator-initiated clinical trials conducted in South Africa. It covers SAE identification, SUSAR reporting, ICSR submission timelines, DSUR submissions, safety narrative preparation, and archiving. It applies to sponsors, investigators, CROs, regulatory affairs, and PV teams.

Responsibilities

• Principal Investigator (PI): Identifies and reports SAEs to the sponsor within 24 hours, completes SAE forms, and ensures timely documentation in the ISF.
• Clinical Research Coordinator (CRC): Assists PI in reporting and filing safety documents.
• Pharmacovigilance (PV) Team: Conducts medical assessment, prepares narratives, and ensures ICSRs are submitted to SAHPRA per timelines.
• Regulatory Affairs (RA): Confirms acknowledgments from SAHPRA and ensures DSUR submissions.
• Quality Assurance (QA): Reviews safety reporting systems, ensuring compliance with inspection readiness standards.
• CRO (if applicable): Supports PV case management and submission activities.

Accountability

The Sponsor’s Qualified Person for Pharmacovigilance (QPPV) or equivalent in South Africa is accountable for ensuring compliance with safety reporting obligations. The PI is accountable for initial SAE detection and prompt reporting.

Procedure

1. SAE Identification and Initial Reporting

1. Document all SAEs in SAE forms within 24 hours of awareness.
2. Forward SAE reports to sponsor for causality and expectedness assessment.
3. File copies of SAE reports in the ISF.

2. ICSR Submission Timelines

1. Fatal or life-threatening SUSARs: submit to SAHPRA within 7 calendar days with follow-up within 8 days.
2. Other SUSARs: submit within 15 calendar days.
3. Non-serious ICSRs: submit as periodic line listings as per SAHPRA guidance.

3. Data Entry and Submission

1. PV team enters ICSRs into SAHPRA’s electronic reporting system.
2. Ensure narratives, laboratory data, and outcomes are included.
3. Retain acknowledgment receipts in the TMF.

4. Development Safety Update Reports (DSURs)

1. Prepare DSUR annually including cumulative safety data.
2. Submit DSUR to SAHPRA within 60 days of the data lock point.

5. Training

1. Ensure all staff involved in PV reporting are trained on SAE reporting timelines and SAHPRA electronic systems.
2. Maintain training logs in TMF.

6. Archiving

1. Archive SAE reports, SUSAR logs, ICSRs, DSURs, and acknowledgment receipts for 15 years or per SAHPRA requirements.

Abbreviations

• SAHPRA: South African Health Products Regulatory Authority
• PV: Pharmacovigilance
• ICSR: Individual Case Safety Report
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• DSUR: Development Safety Update Report
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• QPPV: Qualified Person for Pharmacovigilance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

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

References

• SAHPRA — Clinical Trials and Pharmacovigilance
• 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 Form

Subject ID	Event	Onset Date	Outcome	Investigator Assessment	Date Reported
SA-201	Severe Anemia	10/08/2025	Recovered	Possibly Related	11/08/2025

Annexure-2: ICSR Submission Log

Case ID	Subject ID	Event	Report Type	Date Submitted	Acknowledgment
ICSR-001	SA-202	Seizure	7-day Expedited	15/08/2025	Received

Annexure-3: DSUR Tracker

Protocol No.	DSUR Period	Submission Date	Status	Owner
SA-2025-01	01/08/2024 – 31/07/2025	20/09/2025	Submitted	Neha Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for local pharmacovigilance and ICSR submissions in South Africa.	New SOP created for SAHPRA compliance.	Head of Clinical Research

For more SOPs visit: Pharma SOP.