E Introduction To Clinical It
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  • 1. Clinical IT
    • Clinical IT is responsible for the computer system used to support the work processes involved in the conduct of the clinical trial undertaken by CRC.
    Project Management Site Management Clinical Supply Audit/ Compliance Safety Surveillance Monitoring Regulatory Affairs Statistics Biometrics Data Management Logistics Clinical Trial Environment Work Processes Computer System
  • 2. Importance
    • To ensure that the computer systems used for data capture and storage are performing consistently in accordance with the user requirements, principles of GCP, SOP and applicable requirements
    • To assure the data quality
  • 3. International Regulatory Requirements & Guideline
  • 4. ICH
    • E6: GCP: Consolidated Guideline (May 96)
    • E9: Statistical Principles for Clinical Trials (Feb 98)
    • E3: Structure and Content of Clinical Study Reports (Nov 95)
    • E2: Clinical Safety Data Management: definitions (Oct 94) , data elements (July 97)
  • 5. Some ICH Rules …
    • Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. (ICH GCP 5.1.3)
    • If data are transformed during processing, it should always be possible to compare the original data and observations with the processed data (ICH GCP 5.5.4)
  • 6. FDA
    • 21 CFR part 11: electronic records and electronic signatures, March 1997
    • Guidance for Industry Computerized Systems Used in Clinical Trials
  • 7. Scope of 21 CFR Part 11
    • Electronic records, electronic signatures, and handwritten signatures executed to electronic records are equivalent to paper records and handwritten signatures executed on paper
    • Electronic records are created, modified, maintained, archived, retrieved or transmitted to FDA under a records requirement in an FDA regulation
    • Computer systems, controls and attendant documentation shall be readily available for FDA inspection
  • 8. Some Rules
    • System validation at commissioning and periodically during operation
    • Changes to data that are stored in CDMS require an audit trail . Documentation should include who made the changes, when and why they were made
  • 9. More Rules
    • Data should be retrievable in such a fashion that all information regarding each individual subject in a study is attributable to that subject.
    • Security measures should be in place to prevent unauthorized access to the data and to the computerized system.
  • 10. What is a Computer System?
  • 11. Computer System
    • Computer System:
      • Hardware (IT/IS)
      • Software (e.g. Clintrial CDMS)
    • Work Process
      • People
      • Procedures (SOPs)
      • Equipment or instrumentation
    • Computerized System
      • Computer system used to support work process
      • E.g. Central Randomization, CDM
  • 12. Computer System in Context Computer System Work Process Computerised System (e.g. CDM/ Central Randomisation) Hardware Operating Environment Software Equipment People SOP
  • 13. Life Cycle of a GCP Compliant Computer System
  • 14. Roles & Responsibilities
  • 15. Roles and Responsibilities (1)
    • Computer System Planning
      • Need analysis
      • User Requirement Specification (URS)
        • Good user requirements are critical success factor for any project
    • Computer System Development
      • In-house or Vendor Development
    Planning Development
  • 16. Roles and Responsibilities (2)
    • Computer System Implementation
      • Testing
    • Computer System Operational Use
      • System setup & administration
      • User training
      • Helpdesk support (Change Control Management)
      • System maintenance
    Implementation Operational Use & Maintenance
  • 17. What Clinical IT Professional do?
  • 18. Computer System Validation (1)
    • “… an ongoing process of establishing documented evidence which provides a high degree of assurance that a computerised system will consistently perform according to its predetermined specifications and quality attributes ”
  • 19. Lifetime system validation goals Management control Controlled GCP work processes using computerized systems System reliability Consistent, intended performance of computerized systems Data integrity Secure, accurate, and attributable GCP e-data Auditable quality Documented evidence for control and quality of e-data and e-system e
  • 20. Computer System Validation (2)
    • Research Computer System Validation:
      • CDMS
      • Safety Surveillance System
      • CRF & Query Tracking System
      • Central Randomization System
  • 21. CDMS
    • CDMS is a comprehensive research system to collect, manage, and review trial data.
    • Benefits of CDMS:
      • Meet the extensive record-keeping requirement of a clinical trial
      • Build checks to ensure data quality
      • Ease of data entry
      • Flexible data review and reporting
  • 22. CDMS Setup
  • 23. CDMS Operational Use Data Entry Auto Coding Manual Coding Data Validation Data Retrieval
  • 24. Safety Surveillance System
    • Safety Surveillance System is a comprehensive database application for reporting and tracking clinical adverse events
    • Workflow:
    Enter Code Evaluate Generate Report
  • 25. Safety Surveillance System Data Entry Data Coding Evaluation Reporting
  • 26. Central Randomization Service (1)
    • “ The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.”
    • (ICH GCP 1.48)
  • 27. Central Randomization Service (2)
    • Every high quality randomized trial requires access to a central randomization service.
    • Done centrally to avoid the randomisation being subverted.
    • A computerized system is set up in CRC to provide the central randomisation service .
    • IVR technology is integrated into the system to provide a faster and better service
  • 28. Central Randomization Service (3)
    • IVR Central Randomization Service a f aster and better service:
      • Available 24 hrs a day, 7 days a week
      • Accessible via touch-tone telephone (including mobile) from anywhere at anytime
      • 4 phone lines
      • Automated and no human intervention
      • Secured
  • 29. Central Randomization Service (4) AUTHENTICATION Study ID: XXXXXX Site ID: XXXXXX Investigator ID: XXXX XXX SCREENING Inclusion Criteria (1 to n): Yes Exclusion Criteria (1 to n): No RANDOMIZATION Randomized Treatment: Control/ Treatment Subject ID END Fail Fail CRC Site
  • 30. CRF & Query Tracking System
    • An electronic CRF & Query tracking system to identify and manage bottlenecks, track performance metrics and make data management process more efficient while maintaining the paper/data trail
    • Other Benefits:
      • Quicken turnaround time
      • Reduce the paperwork
      • Allow access to data simultaneously
  • 31. CRF Tracking System DE Verification Data Entry Image Review Scan Login
  • 32. Query Tracking System First Review Send DCF Resolution Proposed Final Review DB Update
  • 33. THE END Thank You