SOP Guide for Pharma

SOP for Use of Electronic Systems and eCRFs

Auditor

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.
See also  SOP for Validation and Qualification of Electronic Systems

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
quality and consistency.
  • Data Queries and Resolution:
    • Monitor eCRF data for discrepancies and raise data queries when necessary.
    • Resolve data queries by verifying data with source documents and making necessary corrections.
  • Data Security and Integrity:
    • Ensure data stored in electronic systems is secure and protected against unauthorized access, loss, or corruption.
    • Implement backup and disaster recovery plans for electronic data.
  • Documentation and Record-Keeping:
    • Maintain records of data entry, queries, and resolutions for audit and regulatory compliance.
    • Document changes made to eCRF data and maintain an audit trail of data modifications.
  • Training and Awareness:
    • Provide training to study personnel on the use of electronic systems and eCRFs.
    • Ensure personnel are aware of data quality, security, and confidentiality practices.
  • Monitoring and Auditing:
    • Monitor the use of electronic systems and eCRFs to ensure compliance with SOPs and regulations.
    • Conduct regular audits of eCRF data to identify and address any issues.

    • Abbreviations Used

    • SOP: Standard Operating Procedure
    • PI: Principal Investigator
    • eCRF: Electronic Case Report Form
    • IT: Information Technology

    Documents

    • Training materials for electronic systems and eCRFs
    • Data entry and validation records
    • Records of data queries and resolutions

    References

    • Regulatory guidelines for the use of electronic systems and eCRFs
    • Institutional policies for data handling and security

    SOP Version

    Version: 1.0

    See also  SOP for Participant Recruitment and Screening
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