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Figure 3 Boxes on left show various steps at the study site. Notations on right indicate role of the INVEST on-line system in the step (from top to bottom). The system provides physicians with the electronic version of the protocol and appropriate references (e.g., JNC VI, links to medical data sources, etc.) to familiarize physicians with the project. The database core controls all data, checks for correctness and determines whether the patient is eligible by comparing data entries made during the first visit with eligibility criteria. Randomization assigns initial study medication strategy. Titration screen presents physicians with protocol-specific options regarding study medications. Physicians determine final prescription. The drug notification system relays final prescription to the drug distribution center to dispense medications and mail to the patient. The system schedules and prints out follow-up visit within protocol-specified window and medication expected in the mail. When the patient returns for follow-up visits, the database core assures that all data values entered are acceptable. Should the patient require change in treatment according to protocol, medications are titrated by the database core and options are presented to the physician by the titration core. In a manner similar to that of first visit, the physician modifies medications within protocol boundaries and the prescription is generated, verified by the physician and forwarded to the drug distribution core.
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