- Meeting abstract
- Open Access
© Stenzhorn; licensee BioMed Central Ltd. 2015
- Published: 22 May 2015
- Core Functionality
- Creation Module
- Ontological Aspect
- Audit Trial
- Answer Possibility
Ontology-based Clinical Trial Management Application, clinical trial data management.
ObTiMA is an ontology-based clinical trial data management system  to support clinicians in designing and conducting clinical trials. The Trial Builder in which all trial aspects can be specified facilitates the design phase; it is therefore possible to define the outline as well as metadata of a trial in a master protocol including trial goals or administrative data.
Since many trials collect similar types of data, it is useful to store CRF forms in a template repository for reuse. When setting up a trial these templates can be reused and adapted to the new trial's needs.
ObTiMA's second core functionality is the management of patient data. The setup of this modul is done automatically based on the items defined in the trial builder and an easy to use interface is provided to enter patient data into CRFs. A protection framework that de-identifies all patient-related data and role-based access control that enables fine-grained control over access ensure the security of all collected data. Furthermore, all system access and changes to data are permanently logged via an audit trial. In summary, the ObTiMA system has been developed in a modular way allowing the straightforward extension of its core functionalities. Currently modules to integrate DICOM images with collected CRF data and a module to facilitate the reporting of Serious Adverse Events are being developed.
The prototype is being validated for GCP compliance.
Supported by p-medicine (European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement No 270089).
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