METHODS AND SYSTEM FOR IMPLEMENTING A CLINICAL TRIAL
First Claim
1. A system for automating the implementation of and collection of data during a clinical trial on living subjects, the system comprising:
- a computer-based clinical trial management system, programmed to define a clinical trial protocol and to store subject data, including a subject identifier;
an electronic subject monitoring system, for acquiring physiological data from the subject during the clinical trial; and
an electronic subject polling module programmed to acquire the physiological data from the subject monitoring system in accordance with the clinical trial protocol, automatically, electronically associate the physiological data with the appropriate subject identifier and transmit the physiological data to the clinical trial management system for storage.
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Accused Products
Abstract
A system and method for automating the implementation of and collection of data during a clinical trial on living subjects includes a computer-based clinical trial management system, programmed to define clinical trial protocols and to store subject data, including a subject identifier; an electronic subject monitoring system, for acquiring physiological data from the subject during the clinical trial; and an electronic subject polling device. The electronic polling device is programmed to acquire physiological data from the monitoring system in accordance with the clinical trial protocols, automatically, electronically associate the physiological data with an appropriate subject ID and transmit the physiological data to the clinical trial management system for storage.
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Citations
20 Claims
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1. A system for automating the implementation of and collection of data during a clinical trial on living subjects, the system comprising:
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a computer-based clinical trial management system, programmed to define a clinical trial protocol and to store subject data, including a subject identifier; an electronic subject monitoring system, for acquiring physiological data from the subject during the clinical trial; and an electronic subject polling module programmed to acquire the physiological data from the subject monitoring system in accordance with the clinical trial protocol, automatically, electronically associate the physiological data with the appropriate subject identifier and transmit the physiological data to the clinical trial management system for storage. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A system for automating the implementation of and collection of data during a clinical trial on living subjects, the system comprising:
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a computer-based clinical trial management system, programmed to define a clinical trial protocol and to store subject data, including a subject identifier; an electronic subject monitoring system, for acquiring ECG data from the subject during the clinical trial, the ECG data including an image file representing the ECG waveform, and a text file representing ECG measurements and analysis data; an electronic subject polling module programmed to acquire the ECG data from the subject monitoring system in accordance with the clinical trial protocol, automatically, electronically associate the physiological data with the appropriate subject identifier and transmit the physiological data to the clinical trial management system for storage; and a cardiologist assignment and review module, programmed to automatically, electronically assign cardiologists to review the ECG data in accordance with the protocol. - View Dependent Claims (16, 17, 18, 19)
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20. A method of implementing and collecting physiological data during a clinical trial, the method comprising:
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developing an electronic database of potential clinical trial subjects; programming a clinical trial management system with a clinical trial protocol; automatically, electronically selecting the subjects for the clinical trial from the database based on a comparison of the protocol with the database, and associating each selected subject with an identifier; programming a subject monitoring system with the subject identifier and connecting the selected subjects to the subject monitoring system; acquiring ECG data from the subject monitoring system; and transmitting the ECG data to the clinical trial management system in accordance with the protocol.
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Specification