| 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. |
