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“headline”: “SOP for Local PV Reporting and Audits”,
“name”: “SOP for Local PV Reporting and Audits”,
“description”: “Comprehensive SOP describing sponsor, investigator, and CRO responsibilities for local pharmacovigilance (PV) reporting and audits in South Korea, in compliance with MFDS and KGCP requirements.”,
“keywords”: “MFDS safety reporting SOP, local PV reporting Korea, ICSR submission Korea, SOP for pharmacovigilance Korea, SOP for SUSAR reporting MFDS, SOP for SAE reporting Korea, SOP for expedited safety reporting Korea, SOP for DSUR submission Korea, SOP for PV database Korea, SOP for safety reporting timelines Korea, SOP for QPPV Korea, SOP for investigator safety reporting Korea, SOP for sponsor PV obligations Korea, SOP for CRO pharmacovigilance Korea, SOP for inspection readiness PV Korea, SOP for pharmacovigilance compliance Korea, SOP for regulatory safety reporting Korea, SOP for adverse reaction reporting Korea, SOP for safety case documentation Korea, SOP for GCP compliance PV Korea, SOP for trial subject safety Korea, SOP for audit readiness safety Korea, SOP for local PV governance Korea, SOP for MFDS pharmacovigilance compliance, SOP for safety reporting and audits Korea”,
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“datePublished”: “2025-08-28”,
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Local PV Reporting and Audits SOP

Purpose

The purpose of this SOP is to establish a standardized process for local pharmacovigilance (PV) reporting and audits in South Korea. It ensures compliance with Ministry of Food and Drug Safety (MFDS) regulations, Korean Good Clinical Practice (KGCP), and international safety reporting standards, thereby safeguarding trial participants and ensuring data integrity.

Scope

This SOP applies to all clinical trials conducted in South Korea under sponsor or investigator responsibility. It includes SAE, SUSAR, and ICSR reporting to MFDS, submission of Development Safety Update Reports (DSURs), PV system audits, and archiving of safety documentation. It applies to sponsors, CROs, investigators, PV officers, and regulatory affairs staff.

Responsibilities

• Sponsor PV Team: Collects, evaluates, and reports safety cases to MFDS and ensures timelines are met.
• Principal Investigator (PI): Reports SAEs to sponsor within 24 hours and files SAE forms in ISF.
• Clinical Research Coordinator (CRC): Supports PI in SAE documentation and maintains site safety records.
• Regulatory Affairs (RA): Submits safety reports, DSURs, and ensures acknowledgment from MFDS.
• Quality Assurance (QA): Conducts audits of PV systems to verify compliance with MFDS and KGCP.
• CRO (if applicable): Supports sponsor in PV reporting and audit preparation.

Accountability

The sponsor’s Qualified Person for Pharmacovigilance (QPPV) or designated local safety officer in South Korea is accountable for PV compliance and audit readiness. The PI is accountable for site-level reporting and documentation.

Procedure

1. SAE and SUSAR Reporting

1. Investigators must notify sponsor of SAEs within 24 hours using SAE forms.
2. Sponsor PV team assesses seriousness, expectedness, and causality of events.
3. SUSARs must be reported to MFDS within 7 days (fatal/life-threatening) or 15 days (others).

2. ICSR Submissions

1. Prepare ICSRs using MFDS reporting format and electronic submission system.
2. Log submissions in ICSR Tracker (Annexure-1).

3. DSUR Preparation and Submission

1. Prepare DSUR annually with cumulative safety data.
2. Submit DSUR to MFDS within 60 days of data lock point.

4. PV Audits

1. QA team conducts annual audits of PV systems, safety case processing, and reporting timelines.
2. Document audit findings and CAPA in Audit Log (Annexure-2).

5. Documentation and Archiving

1. Maintain SAE logs, SUSAR logs, ICSR submissions, DSURs, and audit reports in TMF and ISF.
2. Archive PV documentation for at least 10 years in compliance with MFDS.

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 Tracker (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 Tracker

Annexure-2: Audit Log

Annexure-3: DSUR Submission Log

Revision History

For more SOPs visit: Pharma SOP.