SemanticBits

There is a distinct lack of open source calendaring systems in the clinical trials arena that have the flexible necessary to support a variety of study types. For example, therapeutic, observational, prevention, correlative, ancillary, and biobanking studies all have slightly different needs when it comes to patient scheduling. Furthermore, while many calendaring applications are embedded in large CTOS products, they do not have the capabilities to be integrated into other hospital systems, such as billing and lab systems. This feature greatly reduces double data entry and insures that patients are aware of non-treatment events.

The Patient Study Calendar (PSC) supports the application of a study template (study plan) to study participants and enable the prospective forecasting of visit information, tracking of study participant events and provide a framework for reviewing historical study calendar events. PSC supports various types of studies including therapeutic, observational, prevention, correlative, ancillary, and biobanking studies. The standalone implementation of PSC integrates with the components necessary to create the study calendar plan (protocol authoring), is able to instantiate a plan for a study participant, provides a mechanism for forecasting the events for a participant based on the study plan, and as the participant progresses through the study, represents study events for that participant and provide mechanisms for linking to data about those events in other systems for analysis. These study events are identified at a study participant and event level, enabling the stable linking to external systems such as patient scheduling systems, laboratory interfaces, adverse event reporting modules, case report form collection, electronic data capture (EDC) systems, financial billing and other event-based modules.

PSC provides an open source, highly integratable patient calendaring system for clinical trials.  The core benefits include:

• Create and amend templates that represent activities of a study and release templates to sites as per IRB approval.
• Apply template to subject to generate calendar.
• Schedule the collection of re-consent forms.
• Manage activities for special subject populations.
• Manage state and schedule of subject activities.
• Provide access control to subject calendars within a multi-site environment.
• Export patient calendar in ICS format.
• Provide aggregate view of upcoming patient activities for coordinators.
• Allow coordinators to view upcoming activities of their colleagues.
• Allow managers to balance workload of coordinators.
• Function as the study calendar module of the caBIG Clinical Trials Suite.

PSC provides APIs for data sharing and application interaction. An important component of PSC is modeling the data representations for patient study calendars in the caBIG BRIDG domain analysis model and workflows in the Business Architecture Model (BAM). BRIDG in turn has been adopted by CDISC and HL7 for the purpose of representing clinical research data plans and elements. The intent of the BRIDG harmonization and semantic modeling in general is to provide open and standard interfaces that can provide deep interoperability with other systems or modules.

SemanticBits, in collaboration with Northwestern University, is a key developer of the Patient Study Calendar. The software is being adopted by a number of large cancer centers throughout the cancer research community.

Version 1.0 of PSC was released in December, 2006, version 2.0 released in February, 2008, and the most recent version of 2.4.4 released in June of 2009.

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