Clinical trial management system

专利名称：Clinical trial management system发明人：Karen L. Briegs,David Detoro,Andrew

Keim,Jean-Louis Saillot

申请号：US11363376申请日：20060227

公开号：US20060143047A1公开日：20060629

专利附图：

摘要：A system for designing and monitoring clinical trials includes a main database ofinformation concerning prior clinical trials and resources available to conduct futureclinical trials. In part information in the main database is obtained through data links to

other databases in the enterprise, e.g., human resources and finance databases. Some ofthe information in the main database concerns prior clinical trials and is, in part, in theform of a protocol of (a) scheduled visits of a test subject to a treatment site, (b)measurement of prescribed physical attributes of the subject during the visits and (c)administration of at least one prescribed medical product to the subject during the visitto determine over time the subject's response thereto. The protocols of prior clinicaltrial are stored in the main database in the form of a software template. Users access themain database through their computers which run programs that permit the design andtracking at the user's computer of a clinical trial through access to and use of thesoftware templates. Some users may be served indirectly through subsidiary databasesdistributed globally. These subsidiary databases contain portions of the data in the maindatabase that relates to the geographical regions where they are located. Datasynchronization is maintained by assigning exclusive write capability to rows of thedatabase tables to the main database and subsidiary database, respectively. Then themodified rows are periodically exchanged. The protocol is visually displayed to users as avisit map which shows the visits a subject in the clinical trial is to make to a treatmentcenter and what is to occur at each visit. As visits are made information is added to thesystem so that the progress of the trial can be monitored. If the protocol is in the formof minor tasks that make up a major task, an event manager system can indicatecompletion of the major task based on information entered in the system about thecompletion of the related minor tasks. In addition to visual presentation of the protocol,the system can generate reports and issue orders to other operations, e.g., a clinicalsupplies group, to facilitate the conduct of the trial.

申请人：Karen L. Briegs,David Detoro,Andrew Keim,Jean-Louis Saillot

地址：Neshanic Station NJ US,Lebanon NJ US,Voorhees NJ US,Berkeley Heights NJ US

国籍：US,US,US,US

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