Standard Operating Procedure for Electronic Systems and eCRFs

Purpose

This SOP outlines the procedures for the use of electronic systems and electronic case report forms (eCRFs) in clinical trials and clinical studies. The goal is to ensure accurate, efficient, and secure data collection, storage, and management through the use of electronic systems and eCRFs.

Scope

This SOP applies to all personnel involved in the use of electronic systems and eCRFs in clinical trials and clinical studies, including principal investigators, clinical research coordinators, data managers, and other study staff.

Responsibilities

• Principal Investigator (PI): Oversees the use of electronic systems and eCRFs in the study and ensures compliance with SOPs and regulations.
• Clinical Research Coordinators: Manage data entry into eCRFs and ensure data quality and integrity.
• Data Managers: Monitor data entered into eCRFs and manage data queries, ensuring accurate data handling.
• IT Personnel: Provide technical support for electronic systems and eCRFs, ensuring proper function and security.

Procedure

• System Access and Authentication:
  • Provide secure access to electronic systems and eCRFs through user authentication and authorization processes.
  • Grant access only to authorized personnel based on their roles and responsibilities.
• Data Entry and Validation:
  • Ensure data entry into eCRFs follows study protocols and is completed accurately and in a timely manner.
  • Use built-in validation checks and edit functions to ensure data