A Web-Based Data Management System for Small And Medium Clinical Trials

Transcription

1 A Web-Based Data Management System for Small And Medium Clinical Trials Tzafi Glass and Diklah Geva EMR-IBS 2007 January 23-25, 2007 Eilat Israel 2007, Diklah Geva IntegriStat

2 Introduction-1 A Web based Data Management System (WDMS) can save considerable time and enhance data quality (1). Such systems were developed and used for large scale clinical trials, sponsored by the major pharma companies. In large scale trials it is cost effective to invest in a tailor made system that pays off later by reducing the time to market and saving in manual data management. These systems also enhance: uniformity, quality and integrity of trial data. 2

3 Introduction-2 Current regulatory thinking regarding requirements for management of electronic records(2,3,4), along with web technology advances, set the ground for introducing WDMS suitable not only for large scale trials but also for the medium size trials common in the biomedical Israeli industry. 3

4 Aim In this work we present the principles of a web data management system implemented by IntegriStat for small and medium size clinical trials. This system is flexible enough to easily adapt to large range of trials. This flexibility reduces the overhead cost and implementation time of a new trial and hence is suitable for small and medium trials. 4

5 Data Flow and Users DB Patients Investigator Database Queries Reports 5

6 Data Flow and Users The data collected in the clinical trial site is directly entered to the database via webbrowser. Only minimal training is required in order to enroll new patient and start data entry. Users definitions are : Investigator, studycoordinator, business-director, IT administrator and statistician. Different roles are granted different privileges. 6

7 System Diagram Hardware Software User Internet Browser Data Entry Data Output WDMS Wizard (generator) Customization Implementation Support SQL Based DB Data storage The diagram presents the main system components from three different aspects: Hardware, Software, User 7

8 System Architecture The system is based on state-of-the-art industry standard components, widely used and validated. Web data management platform (OpenClinica (5) ) Application server (Apache Tomcat) Java J2EE (Apache Tomcat) Relational database (PostgreSQL) These components assure the security and robustness of the system 8

9 Main features and activities-1 Activity Manage Study: Submit Data: Validate Data: Description Configuration of studies, sites, CRFs, users. Patient enrollment and data entry Discrepancy notes Automated edit checks Validation report User Administrator, Director Clinicians, Coordinator, Data Entry Coordinator, RA, Data Manager 9

10 Main features and activities-2 Activity Extract Data: System Admin : Description Enables data extraction and filtering of datasets. Configuration, Auditing, User management User Investigators, Statisticians, Directors System Administrator 10

11 Regulatory & Standards HIPAA privacy and security (4) : Medical Privacy - National Standards to Protect the Privacy of Personal Health Information; Key issues the system must address: Authentication, Integrity, Authorization, Availability, Auditing 21 CFR part 11 Electronic Records (2) : Criteria for trustworthiness and reliability of electronic records and electronic signatures; Data in computerized clinical trial systems must be Attributable, Original, Accurate, Contemporaneous, and legible. EMEA under Directive 95 46/EEC (6) : On the protection of individuals with regard to the processing of personal data and on free movement of data. 11

12 System Advantages Quality: Direct data entry by the clinicians familiar with specific clinical terminology. On-line data verification. Integrity Comprehensive Audit trail Monitored user access 12

13 System Advantages Time Savings: Time required to handle and transfer paper case report forms (CRFs) and data clarification forms (DCFs). Managerial: Uniformity of data management in all sites and countries. Online monitor enrollment and progress Introduce timely corrections of systematic errors 13

14 System Limitations Implementation of a WDMS requires the training of research personnel for using new technology and becoming accustomed to the new working procedures. This investment pays off in the advantages that the new technology offers. 14

15 System Extensions The WDMS also offers the opportunity for introducing additional modules such as: Random allocation tool Integrated code books Uniform CRF libraries Integrated messaging system and FAQs 15

16 Discussion The move towards paperless services is now relevant to clinical trials of all sizes. Web systems to manage clinical trials enhance data quality and integrity. We believe that early adoption of a web system provides important benefits in bringing a biomedical product to the market. 16

17 Screen Sample 17

18 References 1. A web based clinical trial management tool-more than data management tool, 27 th Annual ICCB conference, Geneva FDA Guidance for Industry Part 11, Electronic Records: Electronic Signatures Scope and Application (2003) Wikipedia about 21 CFR Part HIPAA privacy and security: 5. OpenClinica organization site 6. EMEA Privacy Directive 95/46/EEC 18

19 Acknowledgements Thanks! We would like to thank Shai Geva for all his help in implementing the system and providing kind support throughout the preparation of this poster

20 Screen Sample-Allocation Tool 20