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“headline”: “SOP for Local PV Reporting and Audits”,
“name”: “SOP for Local PV Reporting and Audits”,
“description”: “Detailed SOP describing sponsor, investigator, and CRO responsibilities for local pharmacovigilance reporting and audits in South Korea under MFDS regulations and KGCP.”,
“keywords”: “Korean PV reporting SOP, SOP for pharmacovigilance Korea, SOP for safety case management Korea, SOP for ICSR reporting Korea, SOP for DSUR submission Korea, SOP for SUSAR reporting Korea, SOP for SAE reporting Korea, SOP for expedited safety submissions Korea, SOP for safety database Korea, SOP for local regulatory reporting Korea, SOP for investigator safety responsibilities Korea, SOP for sponsor PV obligations Korea, SOP for CRO PV activities Korea, SOP for pharmacovigilance audits Korea, SOP for GCP compliance Korea, SOP for MFDS safety governance, SOP for adverse reaction reporting Korea, SOP for PV inspection readiness Korea, SOP for safety record keeping Korea, SOP for trial subject safety Korea, SOP for audit trail pharmacovigilance Korea, SOP for MFDS safety timelines Korea, SOP for electronic PV submissions Korea, SOP for regulatory compliance Korea, SOP for safety reporting documentation Korea”,
“articleSection”: “Standard Operating Procedure”,
“datePublished”: “2025-08-28”,
“dateModified”: “2025-08-28”,
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Local PV Reporting and Audits SOP

Purpose

This SOP establishes standardized procedures for local pharmacovigilance (PV) reporting and audits in South Korea. It ensures compliance with MFDS safety reporting timelines, Korean GCP (KGCP), and international guidelines, thereby protecting patient safety and ensuring inspection readiness.

Scope

This SOP applies to all clinical trials conducted in South Korea under sponsor or investigator responsibility. It includes safety case collection, SAE/SUSAR reporting, ICSR submission, DSUR preparation, PV audits, and archiving of safety documents. It applies to sponsors, CROs, investigators, PV officers, QA, and regulatory affairs staff.

Responsibilities

• Sponsor PV Team: Oversees safety case management, prepares ICSR and DSUR reports, and ensures submission to MFDS within timelines.
• Principal Investigator (PI): Identifies, documents, and reports SAEs within 24 hours to sponsor.
• CRC: Supports PI in documentation and reporting of adverse events.
• Regulatory Affairs (RA): Submits safety reports and ensures acknowledgment from MFDS.
• Quality Assurance (QA): Conducts audits on PV processes, documentation, and timelines.
• CRO (if delegated): Provides PV reporting support and ensures alignment with MFDS requirements.

Accountability

The sponsor’s Qualified Person for Pharmacovigilance (QPPV) or designated Korean safety officer is accountable for PV compliance. The PI is accountable for ensuring site-level safety reporting.

Procedure

1. SAE and SUSAR Reporting

1. Document SAEs in SAE forms and notify sponsor within 24 hours.
2. Sponsor PV team evaluates seriousness, causality, and expectedness.
3. Fatal or life-threatening SUSARs: submit within 7 days; all others within 15 days.

2. ICSR Submissions

1. Prepare ICSRs in MFDS-compliant electronic format.
2. Submit through MFDS PV reporting systems.
3. Log cases in ICSR Log (Annexure-1).

3. DSUR Preparation and Submission

1. Compile DSUR annually with cumulative global and local safety data.
2. Submit DSUR to MFDS within 60 days of data lock point.

4. PV Audits

1. QA team performs annual audits of PV systems and safety databases.
2. Audit findings are documented with CAPA in Audit Log (Annexure-2).

5. Documentation and Archiving

1. Maintain SAE forms, SUSAR reports, ICSR logs, DSURs, and audit reports in TMF/ISF.
2. Archive PV records for a minimum of 10 years as per MFDS requirements.

Abbreviations

• MFDS: Ministry of Food and Drug Safety
• KGCP: Korean Good Clinical Practice
• PV: Pharmacovigilance
• QPPV: Qualified Person for Pharmacovigilance
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• ICSR: Individual Case Safety Report
• DSUR: Development Safety Update Report
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• ISF: Investigator Site File
• TMF: Trial Master File

Documents

1. ICSR Log (Annexure-1)
2. Audit Log (Annexure-2)
3. DSUR Submission Log (Annexure-3)

References

• MFDS — Ministry of Food and Drug Safety
• ICH E6(R2) Good Clinical Practice
• ICH E2F: Development Safety Update Report

Version: 1.0

Approval

Annexures

Annexure-1: ICSR Log

Annexure-2: Audit Log

Annexure-3: DSUR Submission Log

Revision History

For more SOPs visit: Pharma SOP.