Southern California Clinical and Translational Science Institute
Translating Science into Solutions for Better Health

Monitoring and Auditing Bootcamp: 3. Auditing GCP Systems for Data Integrity

In this series, we will discuss data integrity, GCP systems, regulatory framework enforcement, and auditing for data integrity

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Course Syllabus/Topics

  1. Data Integrity concepts
    • ALCOA + CCEA
    • Paper replaced with electronic files
    • GMP inspections have revealed data integrity problems all over the world
  2. GCP systems
    • EDC-Electronic Data Capture
    • IWRS-Interactive Web Response
    • Instrument Systems
    • LIMS-Laboratory Information Management
    • PIMS- Patient Information Management
    • PV- Pharmacovigilance
    • ECG reading systems
    • Radiological image reading systems
    • Programs to analyze and report subject data
    • LMS-Learning Management
    • EDMS- Electronic Document Management
    • ETMF- Electronic Trial Master File
    • CTMS- Clinical Trial Management
  3. Regulatory framework for enforcement
    • Investigator, Sponsor and CRO are 3 responsible entities in a clinical trial
    • Intended Recordkeeping ICH E-6: Investigators are responsible for all data in CRFs. Any discrepancies are the responsibility of the investigators.
    • IVRS Provider, EDC Provider, ePRO Provider, CRO, Central Lab are all selected by the Sponsor. Sponsor delegates all the responsibilities.
    • Investigator prepares case histories and sends data to the contractors/sponsors.
  4. Auditing for data integrity
    • Quality Management System (QMS) auditing helps us verify that a provider has processes, procedures, equipment, facilities, supporting documentation and qualified personnel to provide high quality services.
    • Data integrity audits show how a sponsor is preventing and detecting data integrity problems and risks.
    • Preparing for a data integrity audit
      • Review:
        • Protocol
        • Quality agreement
        • Documented requirements
        • Instructions provided and data transfer specifications
      • Ask clinical team about problems they experienced
        • Study manager
        • Data manager
        • Statistician
        • Programmer
        • Technical monitors
      • Identify parameters that have a serious impact on subject safety:
        • Exclusionary parameters
        • Change in parameters
        • Efficacy parameters
      • Identify equipment used to create those parameters
      • Research the equipment
      • Draft a data flow diagram
    • Conducting a data integrity audit
      • Don’ts:
        • Read all QMS documents
        • Focus only on computer system validation
        • Review descriptions
        • Read all disaster recovery plans
      • Do’s:
        • Work to develop high quality data
        • Focus on implementation parameters
        • Look at audit trails
        • Pay careful attention to how flat files are managed
        • Concentrate on QMS documents that support your work