Clinical trials management system and method

摘要

Protocol meta-models are made available to a protocol designer. Each protocol meta-model includes a list of preliminary patient eligibility attributes appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Once a patient is enrolled into a study, the protocol database indicates to a clinician what tasks are to be performed at each patient visit. These tasks can include both patient management tasks and data management tasks.

主权项

1. A method of designing a clinical protocol, the method comprising:
accessing a plurality of protocol meta-models using a computing device, the plurality of protocol meta-models associated with respective diseases; selecting a protocol meta-model of the plurality of protocol meta-models using the computing device, the protocol meta-model including a set of patient eligibility criteria and a set of workflow actions which are relevant to a disease associated with the protocol meta-model, each patient eligibility criterion of the set of patient eligibility criteria including an attribute associated with the disease and a range of values for the attribute to designate whether the patient eligibility criterion is satisfied; and generating, by the computing device, an intelligent clinical protocol database, the intelligent clinical protocol database being encoded with one or more of the set of patient eligibility criteria and a protocol schema of one or more of the set of workflow actions.