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

e

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