Abstract: Structure and methodology for reducing risk of protocol ambiguities that could lead to operational failures in the conduct of clinical trials. Roughly described, an analyst encodes the features of a protocol into a highly structured, formal model created specifically to capture issues that tend to cause operational difficulties. The process forces the analyst to look for specific parameters in the text version of the protocol. The system creates a database of the protocol as encoded, and can display the protocol schema as a graphical network of protocol events and temporal links. In one aspect, the database includes an object class into which an analyst encodes descriptions of operational uncertainties. The system can display the network in graphical-visual form, with a human-perceptible indication of objects that have operational uncertainties associated therewith. Advantageously, the formal protocol model includes slots for encoding temporal constraints among protocol events.

Abstract: Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements m the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.

Abstract: Roughly described, a machine-readable protocol database identifies a sequence of workflow tasks for a clinical trial protocol. The sequence of workflow tasks is organized as a graph whose nodes can contain or represent patient contact event objects, with one or more of the tasks assigned to each patient contact event object. The graph also indicates preferred or expected times for a patient to transition from one node to the next, and optionally also indicates a predicted likelihood that different alternative paths will be taken to a common destination node. A problem-solving method automatically extracts the time duration expected or predicted for a patient to traverse each separate phase of the protocol. Such durations are provided to a simulation engine which automatically generates timeline forecasts of patient progress through at least part of the workflow tasks prescribed by the protocol.