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“headline”: “SOP for eSource and eClinical Data Expectations”,
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“description”: “Comprehensive SOP detailing investigator, sponsor, and CRO responsibilities for eSource and eClinical data collection, validation, storage, and submission in South Korea under MFDS regulations.”,
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“datePublished”: “2025-08-28”,
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eSource and eClinical Data Expectations SOP

Purpose

This SOP defines processes for managing electronic source (eSource) and eClinical data in clinical trials conducted in South Korea. It ensures compliance with MFDS regulations, Korean Good Clinical Practice (KGCP), and international GCP standards regarding data integrity, authenticity, confidentiality, and retention.

Scope

This SOP applies to all sponsor-led and investigator-initiated trials using eSource, EDC, eCRF, CTMS, or electronic consent systems in South Korea. It covers data entry, validation, security, audit trails, archiving, and regulatory submission of eClinical data.

Responsibilities

• Sponsor: Ensures systems used for eClinical data meet MFDS and KGCP requirements, validates vendor systems, and oversees compliance.
• Principal Investigator (PI): Ensures accurate and timely entry of eSource data, verifies completeness, and protects subject confidentiality.
• Clinical Research Coordinator (CRC): Supports PI in entering and validating eSource data.
• Data Management Team: Maintains database integrity, runs edit checks, and ensures data quality.
• Quality Assurance (QA): Audits systems for compliance with ALCOA principles and data integrity.
• CRO: Provides system support and ensures delegated tasks meet MFDS compliance standards.

Accountability

The Sponsor’s Head of Data Management is accountable for compliance with MFDS eClinical requirements. The PI is accountable for ensuring subject data accuracy and integrity at site level.

Procedure

1. System Validation

1. Ensure all eClinical systems are validated per 21 CFR Part 11 and MFDS requirements.
2. Maintain System Validation Report in TMF (Annexure-1).

2. Data Entry and Validation

1. Record eSource data directly into validated systems (EDC, eCRF).
2. Perform edit checks and query resolution to ensure accuracy.
3. PI must verify final data entries with electronic signature.

3. Audit Trail

1. Ensure all changes to data are recorded with user ID, date, time, and reason.
2. Audit trails must be reviewable and retained with study records.

4. Data Security

1. Grant access only to authorized personnel.
2. Implement role-based permissions and password controls.
3. Back up eClinical data daily and store securely.

5. Data Submission to MFDS

1. Prepare eClinical datasets per MFDS formatting requirements.
2. Submit datasets and associated metadata for regulatory review.

6. Archiving

1. Archive eClinical data, metadata, and audit trails in TMF and ISF.
2. Ensure minimum retention of 10 years post-study, or longer if required by MFDS.

Abbreviations

• MFDS: Ministry of Food and Drug Safety
• KGCP: Korean Good Clinical Practice
• eSource: Electronic Source Data
• EDC: Electronic Data Capture
• eCRF: Electronic Case Report Form
• CTMS: Clinical Trial Management System
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• QA: Quality Assurance
• CRO: Contract Research Organization
• ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. System Validation Report (Annexure-1)
2. Submission Log (Annexure-2)
3. Audit Trail Report (Annexure-3)

References

• MFDS — Ministry of Food and Drug Safety
• ICH E6(R2) Good Clinical Practice
• FDA 21 CFR Part 11 Guidance

Version: 1.0

Approval

Annexures

Annexure-1: System Validation Report

Annexure-2: Submission Log

Annexure-3: Audit Trail Report

Revision History

For more SOPs visit: Pharma SOP.