SOP for eSource and eClinical Data Expectations

Posted on digi By digi

SOP for eSource and eClinical Data Expectations

{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/esource-and-eclinical-data-expectations”
},
“@id”: “https://www.clinicalstudies.in/esource-and-eclinical-data-expectations”,
“headline”: “SOP for eSource and eClinical Data Expectations”,
“name”: “SOP for eSource and eClinical Data Expectations”,
“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.”,
“keywords”: “eSource SOP Korea, eClinical data SOP Korea, SOP for electronic source data Korea, SOP for MFDS eClinical requirements, SOP for electronic CRF Korea, SOP for investigator site electronic data SOP, SOP for sponsor eClinical responsibilities Korea, SOP for CRO electronic data SOP Korea, SOP for data integrity MFDS Korea, SOP for ALCOA principles Korea, SOP for regulatory compliance eSource Korea, SOP for trial master file eClinical Korea, SOP for eClinical inspection readiness Korea, SOP for data validation Korea, SOP for electronic records SOP Korea, SOP for audit trail requirements Korea, SOP for electronic consent data Korea, SOP for clinical trial management systems Korea, SOP for safety database eClinical Korea, SOP for data

retention Korea, SOP for eSource to TMF migration Korea, SOP for data authenticity Korea, SOP for electronic records archiving Korea, SOP for secure access electronic data Korea, SOP for GCP compliance eClinical Korea”,
“articleSection”: “Standard Operating Procedure”,
“datePublished”: “2025-08-28”,
“dateModified”: “2025-08-28”,
“author”: { “@type”: “Organization”, “name”: “Clinicalstudies.in” },
“publisher”: {
“@type”: “Organization”,
“name”: “Clinicalstudies.in”,
“logo”: { “@type”: “ImageObject”, “url”: “https://www.clinicalstudies.in/logo.png” }
}
}

See also  SOP for EC Registration Verification and Communications (Country-Specific)

Published on 25/12/2025

eSource and eClinical Data Expectations SOP

Department Clinical Research
SOP No. CS/MFDS-EDATA/196/2025
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 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.
See also  SOP for ATMP Trial Design and Submissions (Advanced Therapies)

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
See also  SOP for HDEC Ethics Submissions and Conditions of Approval

Documents

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

System Validation Date Validated By Status
EDC v2.0 01/08/2025 Neha Sharma Validated

Annexure-2: Submission Log

Date Protocol No. Dataset Submitted To Status
12/08/2025 KR-2025-02 Clinical Dataset v1.0 MFDS Under Review

Annexure-3: Audit Trail Report

Date User Data Changed Reason Status
15/08/2025 CRC01 Blood Pressure value Correction after verification Recorded

Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
28/08/2025 1.0 Initial SOP for eSource and eClinical data expectations under MFDS guidelines. New SOP created for Korean compliance. Head of Clinical Research

For more SOPs visit: Pharma SOP.

MFDS — Unique SOPs (South Korea), SOP for GCP Tags:, , , , , , , , , , , , , , , , , , , , , , , ,