KOLOREKTUM.CZ | COLORECTAL CANCER SCREENING [ISSN 1804-0888]
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PARTNERS AND EXPERT GUARANTORS
Partners and expert guarantors: MZ ČR, ČGS, SVL, SPL ČR, ČGPS, ČOS, VIZE
Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University
PROJECT SUPPORT
Project support: Roche, Ipsen, Orion Diagnostica, OnkoMaják
For health professionals TECHNICAL SOLUTION

Technical solution: Description

Introduction

From the technical point of view, data from colorectal cancer screening are collected via an on-line application which is accessible to all authorized users. Its three-layer architecture is based on a central web server (Windows Server) and a central database server (ORACLE). Both servers are located in a secured server room with a strictly controlled physical access. All network access to these servers is secured with a firewall. Data transfer and all on-line communication is accomplished via encrypted channels. The application software has been developed and maintained in compliance with the ISO 20 000 standard on the provision of IT services.

General characteristics of the system

The database system was originally based on a modified version of TrialDB system, which is being developed in the Center for Medical Informatics, Yale University School of Medicine, USA[1-3]. The on-line system is newly customized for the collection of specific clinical data of the Colorectal Cancer Screening Programme. The system is actually designed as a robust base for data collection in clinical trials and/or clinical registries. The on-line application is widely accessible via a standard internet browser.

The key elements of the system involve tools for:

  • user-friendly definition and creation of forms used in data collection,
  • administration of user accounts and access rights,
  • processes for data export and import,
  • creation of validation rules and reports,
  • monitoring of the system.

The main advantages of this system involve a centralized administration, an uniform appearance of forms for data collection in all registries and an easy development of new, extended functions.

Basic characteristics of the system

  • The system is very user-friendly: all data are entered via web forms which are analogical to paper collection (classical CRF).
  • The data can be entered into the registry from any computer connected to internet and equipped with the any web browser (Internet Explorer, Mozilla Firefox etc.; it must support the encrypted communication with a 128-bit SSL protocol).
  • No additional software needs to be installed on the client's computer.
  • Only authorized persons have access to the registry, using their login and password.
  • The data in the registry are anonymized, i.e. the patients' records are kept under codes (ID) which do not allow to identify the person. In this way, the system meets the valid rules on the protection of personal data.
  • All data transfer is encrypted to prevent a potential abuse during the transfer.
  • All submitted data are collected in a central computer - server, where they are safely stored in a database, administered in the ORACLE 9i system.
  • The data can be exported for authorized users as a local database for further processing.
  • The user can print the filled forms or save them on a local computer in the MS Excel format.

Sharing patients

The standard solution is realized in such way that each centre (hospital) has only access to its own data. This is defined by user rights of individual centres (the so-called “individual access control”).

Another option is to configure user rights in such way that the centres can share data of their patients, transfer patients’ data from one centre to another, access to individual data forms etc. However, such technological and communication settings have to be approved by all involved data owners as well as by the expert council over the project.

Applied technology

Thin client – internet browser:

  • Any web browser (Internet Explorer, Mozilla Firefox etc.)
  • Data collection, viewing, editing etc.
  • Analytical functions
  • Client scripts facilitating data entry

Web server (application server):

  • Microsoft Windows 2003 Server
  • Microsoft IIS
  • Web application
  • Server-side scripts
  • ASP Language

Database server

  • SUSE Linux Enterprise Server
  • Oracle database
  • Central data repository
  • Definition and design of forms for data collection
  • Definition and administration of user accounts and rights
  • Validation rules

References

  1. Nadkarni PM, Brandt C, Frawley S, Sayward FG, Einbinder R, Zelterman D, Schacter L, Miller PL. 1998. Managing attribute--value clinical trials data using the ACT/DB client-server database system. J Am Med Inform Assoc 5(2):139-151.
  2. Nadkarni PM, Brandt CM, Marenco L. 2000. WebEAV: automatic metadata-driven generation of web interfaces to entity-attribute-value databases. J Am Med Inform Assoc 7(4):343-356.
  3. Nadkarni PM, Marenco L. 2001. Easing the transition between attribute-value databases and conventional databases for scientific data. Proc AMIA Symp:483-487.

Last updated on 23 February 2015