AI AND ML ASSISTED SYSTEM FOR DETERMINING SITE COMPLIANCE USING SITE VISIT REPORT

Methods and systems to automatically construct a clinical study site visit report (SVR), conduct the SVR, evaluate the SVR in real-time, and provide feedback while the SVR is being conducted. Responses to the SVR include user-selectable answers and natural language notes. Each response is evaluated...

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Hauptverfasser: Patil, Rajneesh, Bonageri, Virupaxkumar, Shastri, Gargi
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:Methods and systems to automatically construct a clinical study site visit report (SVR), conduct the SVR, evaluate the SVR in real-time, and provide feedback while the SVR is being conducted. Responses to the SVR include user-selectable answers and natural language notes. Each response is evaluated as it is submitted based on a combination of pre-configured rules and a computer-trained model. If an anomaly is detected and is not already captured in the SVR, an alert is generated during performance of the SVR. The alert may include recommended remedial action.