Systems for the collection of clinical data
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Software solution: Technology used at IBA

   General characteristics of electronic registries
   Technology used at IBA
   Reports
   Data validation
   Development of tailor-made database systems

Introduction
Basic characteristics of the system
Sharing patients
Applied technology
References

Introduction

 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 individual projects. 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.

IBA further supports the SW background of the project through an original analytic tool, called COBRA (Comprehensive Data Browser). COBRA is able to communicate the database of the project and returns standard statistical reporting or user-specific analytic outcomes, all in forms of final tables and figures. COBRA works both in locally installed and internet version.

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 browser MS Internet Explorer 5.5 or higher (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:

  • Internet Explorer 5.5 or higher
  • 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.