SOP for SAE reporting Korea – Clinical Research Made Simple

SOP for Local PV Reporting and Audits

digi — Thu, 04 Sep 2025 05:29:34 +0000

SOP for Local PV Reporting and Audits

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Local PV Reporting and Audits SOP

Department	Clinical Research
SOP No.	CS/MFDS-PV/199/2025
Supersedes	N.A.
Page No.	1 of 25
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

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

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

2. ICSR Submissions

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

3. DSUR Preparation and Submission

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

4. PV Audits

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

5. Documentation and Archiving

Maintain SAE forms, SUSAR reports, ICSR logs, DSURs, and audit reports in TMF/ISF.
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

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

References

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: ICSR Log

Date	Case ID	Event	Submitted To	Status
15/08/2025	ICSR-202	QT Prolongation	MFDS	Submitted

Annexure-2: Audit Log

Date	Audit Area	Findings	CAPA	Auditor
20/08/2025	PV Reporting Timelines	2 delayed SAE submissions	Training of staff completed	Neha Sharma

Annexure-3: DSUR Submission Log

Protocol No.	Period	Submission Date	Status	Owner
KR-2025-06	01/08/2024 – 31/07/2025	20/09/2025	Submitted	Rajesh Kumar

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for local PV reporting and audits under MFDS regulations.	New SOP created for compliance with Korean GCP and MFDS safety requirements.	Head of Clinical Research

For more SOPs visit: Pharma SOP.

SOP for Local PV Reporting and Audits

digi — Wed, 03 Sep 2025 16:11:06 +0000

SOP for Local PV Reporting and Audits

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Local PV Reporting and Audits SOP

Department	Clinical Research
SOP No.	CS/MFDS-PV/198/2025
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 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

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

2. ICSR Submissions

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

3. DSUR Preparation and Submission

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

4. PV Audits

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

5. Documentation and Archiving

Maintain SAE logs, SUSAR logs, ICSR submissions, DSURs, and audit reports in TMF and ISF.
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

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

References

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: ICSR Tracker

Date	Case ID	Event	Submitted To	Status
15/08/2025	ICSR-101	Hepatic Failure	MFDS	Submitted

Annexure-2: Audit Log

Date	Audit Area	Findings	CAPA	Auditor
20/08/2025	PV System	Delayed SAE entry	Implemented corrective training	Neha Sharma

Annexure-3: DSUR Submission Log

Protocol No.	Period	Submission Date	Status	Owner
KR-2025-05	01/08/2024 – 31/07/2025	20/09/2025	Submitted	Rajesh Kumar

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for local PV reporting and audits under MFDS regulations.	New SOP created for Korean compliance.	Head of Clinical Research

For more SOPs visit: Pharma SOP.