Protocol for Electronic Data Management in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the use of software and electronic data capture (EDC) systems in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring efficient, accurate, and compliant data management.

Scope

This SOP applies to all study personnel involved in the use of software and electronic data capture systems for data entry, validation, monitoring, and reporting in BA/BE studies, including Investigators, Data Managers, Clinical Research Associates (CRAs), and IT Personnel.

Responsibilities

• The Investigator is responsible for ensuring the integrity, accuracy, and security of study data entered into electronic systems, in compliance with study protocols, regulatory requirements, and data management procedures.
• The Data Manager is responsible for configuring, validating, and maintaining electronic data capture (EDC) systems, ensuring that data entry screens, validation checks, and reporting functions meet study requirements and regulatory standards.
• The Clinical Research Associate (CRA) is responsible for monitoring data entry and quality control processes in EDC systems, verifying data accuracy and completeness, and resolving any discrepancies or data queries with study sites and data managers.
• The IT Personnel is responsible for providing technical support, troubleshooting, and system maintenance for EDC systems, ensuring uptime, performance, and security of electronic data capture platforms throughout the study conduct.

Procedure

1. Select and validate electronic data capture (EDC) systems suitable for the study requirements, considering factors such as user interface, data entry features, validation checks, reporting capabilities, and compliance with regulatory standards.
2. Configure EDC systems according to study protocols and data management plans, including data entry screens, edit checks, skip patterns, and user access controls, to ensure efficient and compliant data capture and validation.
3. Provide training to study personnel on the use of EDC systems, including data entry procedures, validation checks, query resolution, and reporting functions, ensuring proficiency and compliance with data management procedures.
4. Implement data validation checks and quality control measures in EDC systems to ensure data accuracy, completeness, and consistency, including range checks, logic checks, and query generation for data discrepancies.
5. Monitor data entry activities in EDC systems regularly, reviewing data completeness, accuracy, and timeliness, and resolving any discrepancies or data queries with study sites and data managers promptly to maintain data integrity.
6. Generate data listings, summary tables, and reports from EDC systems for data analysis, monitoring, and reporting purposes, ensuring compliance with study protocols, regulatory requirements, and sponsor specifications.
7. Document all data management activities, including system configurations, validation procedures, user training records, and data quality control measures, to maintain a complete audit trail of electronic data capture processes.
8. Conduct regular audits and inspections of EDC systems, data entry practices, and data management procedures, to identify and address any deficiencies, deviations, or non-compliance issues promptly.
9. Implement corrective and preventive actions (CAPAs) to address any deficiencies or non-compliance issues identified during audits or inspections, ensuring continuous improvement and adherence to best practices in electronic data management.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• EDC – Electronic Data Capture
• CRA – Clinical Research Associate
• IT – Information Technology
• CAPA – Corrective and Preventive Actions

Documents

• Data Management Plan
• Electronic Data Capture System Validation Plan
• User Training Records
• Data Quality Control Logs

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for electronic data capture (EDC) systems in clinical research.

SOP Version

Version 1.0