ObTiMA is an ontology-based clinical trial management system intended to support clinicians in both designing and conducting clinical trials. The design phase is facilitated by the Trial Builder in which all aspects of a clinical trial can be specified: A trial chairman can define the outline and metadata of a trial in a master protocol to describe, e.g., trial goals or administrative data. He can further setup treatment plans for guiding clinicians through individual patient treatment where events, e.g., surgery or chemotherapy, can be defined with all necessary information. Also, the particular treatment order can be freely setup on a timeline as well as treatment stratifications and randomizations to be applied for a patient. A Case Report Form (CRF) can be assigned to each treatment step to collect documentation data.
The ontology-based creation of CRFs in the Trial Builder is one of ObTiMA's major functionalities. A graphical user interface allows defining content, navigation, and layout of CRFs to capture all patient data during a trial, e.g., medical findings or diagnostic data. The resulting descriptions are based on ACGT Master Ontology concepts for each CRF item along with metadata, e.g., data type and measurement unit, and used to setup the trial database.
The user interface makes the underlying aspects of the ontological metadata transparent to user and tries to overcome the gap between clinical practice and the actual logical representation of ontological concepts. (Even if natural language descriptions are given for concepts, those often do not mirror the needs of clinical perception of reality. Therefore an application-specific, simplified view of the ontology is given showing only its relevant portions in a clinician-friendly way.) When an item has been created based on a concept, its attributes are determined automatically, e.g., label, data type or answer possibilities but can be manually adopted.
Since many trials collect similar or equal data, it is possible to store components of or complete CRFs in a repository as templates. When setting-up a clinical trial, fitting CRF templates can either be directly reused or can be quickly created by plugging together existing CRF components. This in turn fosters the CRF standardization since CRFs can then readily be compared on the level single items (through ontological concepts) and also on the component level or in their entirety.
The second major functionality is the patient data management system supporting clinicians during a clinical trial. It is automatically set-up based on the items defined in the Trial Builder in the design phase. It guides the clinicians through the treatment of the individual patients according to the given treatment plans and provides an easy user interface to fill in the CRFs for a patient (again hiding the actual underlying ontology concepts from the clinician). When the PDMS is set-up, the trial database is automatically derived from the ontology-based CRF definitions. Thus, given appropriate rights are given, the database can then also be accessed by other trials or applications through using a semantic mediation service based on the ontology.
ObTiMA itself is composed of different modules. Besides the above described basic components a DICOM server and DICOM viewer, a SAE and SUSAR reporting tool and a consultation tool are integrated. These tools are optional to handle images used in clinical trials, to simplify the SAE and SUSAR reporting according to GCP criteria. The consultation tool will store all consultations in a standardized way in the trial database. ObTiMA itself fulfils GCP criteria, including an Audit Trail. Data safety and security are guaranteed as pseudonymization of private data is done according roles and rights assigned to users of ObTiMA. It is of utmost importance that ObTiMA and TOB will be certified for the use within clinical trials.
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