e introduction to clinical it
DESCRIPTION
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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
MonitoringRegulatory Affairs
StatisticsBiometrics
Data Management Logistics
Clinical Trial Environment
Work Processes Computer System
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
International Regulatory Requirements & Guideline
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)
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)
FDA 21 CFR part 11: electronic records
and electronic signatures, March 1997
Guidance for Industry Computerized Systems Used in Clinical Trials
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
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
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.
What is a Computer System?
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
Computer System in Context
Computer System Work Process
Computerised System (e.g. CDM/ Central Randomisation)
Hardware
Operating Environment
Software
Equipment
People
SOP
Life Cycle of a GCP Compliant Computer System
Roles & Responsibilities
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
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
What Clinical IT Professional do?
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”
Lifetime system validation goals
Management controlControlled GCP workprocesses usingcomputerized systems
System reliabilityConsistent, intendedperformance ofcomputerized systems
Data integritySecure, accurate, andattributable GCP e-data
Auditable qualityDocumented evidence forcontrol and quality ofe-data and e-system
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Computer System Validation (2)
Research Computer System Validation: CDMS Safety Surveillance System CRF & Query Tracking System Central Randomization System
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
CDMS Setup
CDMS Operational Use
Data EntryAuto
CodingManualCodingData
ValidationData
Retrieval
Safety Surveillance System Safety Surveillance System is a
comprehensive database application for reporting and tracking clinical adverse events
Workflow:
Enter Code Evaluate Generate Report
Safety Surveillance System
Data EntryData
CodingEvaluationReporting
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)
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
Central Randomization Service (3)
IVR Central Randomization Service a faster 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
Central Randomization Service (4)
AUTHENTICATIONStudy ID: XXXXXXSite ID: XXXXXX
Investigator ID: XXXXXXX
SCREENINGInclusion Criteria (1 to n): Yes Exclusion Criteria (1 to n): No
RANDOMIZATIONRandomized Treatment:
Control/ TreatmentSubject ID
END
Fail
Fail
CRC
Site
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
CRF Tracking System
DE Verification
Data Entry
Image Review
Scan
Login
Query Tracking System
First Review
Send DCF
Resolution Proposed
Final Review
DB Update
THE END
Thank You