Clinical trials are defined, managed and evaluated according to an overall end-to-
end system. The
central authority creates protocol meta-models and makes them available to
clinical trial protocol designers. Each meta-model includes a short
list of preliminary patient eligibility attributes which are 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. Sponsors and individual clinical sites have controlled access to the protocols. Study sites make reference to the pertinent protocol databases to which they have access in the protocol
database library in order to perform patient eligibility screening. Once a patient is enrolled into a study, the protocol
database indicates to the clinician what tasks are to be performed at each
patient visit. These tasks can include both
patient management tasks and
data management tasks. The
workflow graph advantageously also instructs the
proper time for the clinician to obtain a patient's informed consent. The
system reports patient progress to study sponsors, who can then monitor the progress of the trial, and to a
central authority which can then generate performance
metrics. Advantageously, a common controlled
medical terminology database is used by all components of the
system.