Clinical trial monitoring system and method
First Claim
1. A method of monitoring clinical trial performance, the method comprising:
- creating one or more templates and storing the templates in a database, wherein the templates include data fields that can be filled by entering protocol data, the protocol data providing information about one or more elements of a protocol for the clinical trial;
downloading templates that have been filled with protocol data, from the database to one or more remote devices via a network;
prompting for the performance of at least one protocol element;
requesting performance data that contain information relating to any actual performance of one or more of the protocol elements; and
receiving the performance data and uploading the performance data from the remote devices onto the database.
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Accused Products
Abstract
A method and system are presented for monitoring the performance of a clinical trial, and the adherence of trial participants to a protocol for the clinical trial. A plurality of templates are provided, which can be populated with protocol data can be entered that relate to behavioral elements of the protocol. The populated templates are downloaded to a plurality of remote devices. The remote devices generate, upon receipt of the templates populated with protocol data, prompting messages that prompt participants whether protocol elements have been performed, and that request performance data relating to any actual performance of the protocol elements. Based on the performance data, reports are periodically generated that compare actual performance of the protocol elements with expected or desired performance of the protocol elements.
43 Citations
22 Claims
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1. A method of monitoring clinical trial performance, the method comprising:
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creating one or more templates and storing the templates in a database, wherein the templates include data fields that can be filled by entering protocol data, the protocol data providing information about one or more elements of a protocol for the clinical trial;
downloading templates that have been filled with protocol data, from the database to one or more remote devices via a network;
prompting for the performance of at least one protocol element;
requesting performance data that contain information relating to any actual performance of one or more of the protocol elements; and
receiving the performance data and uploading the performance data from the remote devices onto the database. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of monitoring performance of a clinical trial, the method comprising:
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accessing a remote database to download therefrom one or more templates over a network, the templates include data fields that can be filled by entering protocol data that provide information about one or more elements of a protocol for the clinical trial;
causing prompt messages to be sent to one or more participants of the trial, the prompt messages alerting the participants that performance of at least one protocol element is necessary;
requesting from at least one participant performance data relating to actual performance, if any, by the participant of one or more protocol elements;
in response to receipt of the performance data, generating a periodic report that assesses how well the trial protocol is being adhered to.
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11. A system for monitoring performance of a clinical trial, the system comprising:
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a database configured to store therein a plurality of templates that include data fields which can be filled by entering protocol data, the protocol data containing information relating to one or more elements of a protocol for the clinical trial, the database being linked to one or more remote devices through a communications network; and
a controller configured to control access to the database, and to control communications between the database and the remote devices over the network;
wherein the controller is configured to cause one or more templates to be downloaded over the network to the remote devices when the templates have been filled with at least some protocol data, so that the remote devices can generate one or more prompt signals that prompt for performance of one or more protocol elements in accordance with the protocol data, and that request performance data relating to any actual performance of the protocol elements; and
wherein the controller is further configured to upload the performance data from the remote devices and to store the performance data in the database. - View Dependent Claims (12, 13, 14, 15, 16)
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17. A machine-readable medium having stored therein instructions that, when executed by a computer, cause the computer to:
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create a plurality of templates and store the templates in a database, wherein the templates include data fields into which protocol data can be entered, the protocol data containing information that relate to one or more elements of a protocol for a clinical trial;
entering at least some protocol data into one or more templates, and downloading the templates containing the protocol data from the database onto at least one remote device via a network, so that the remote device can generate and display prompt signals that ask for at least some of the protocol elements to be performed in accordance with the protocol data entered in the templates, and that request performance data relating to any actual performance of the protocol elements; and
upload the performance data from the remote device onto the database, and store the performance data in the database.
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18. A computer system for monitoring clinical trial performance, the system comprising:
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means for creating and storing in a database a plurality of templates that include data fields into which protocol data can be entered, the protocol data providing information regarding one or more elements of a clinical trial protocol;
means for downloading from the database onto one or more remote devices one or more templates into which protocol data have been entered;
means for generating and displaying prompt signals which prompt for the performance of at least some of the protocol elements, and which request performance data relating to any actual performance of one or more protocol elements;
means for uploading any received performance data from the remote devices onto the database, and storing the performance data in the database.
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19. A monitoring apparatus for monitoring performance of a clinical trial, the apparatus comprising:
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means for communicating with a remote database having stored therein a plurality of templates that include data fields into which protocol data can be entered, the protocol data providing information relating to one or more elements of a protocol for the clinical trial;
a memory, a display, and an input device; and
a controller configured to control access to the memory, to control display of messages on the display, and to control communications with the remote database;
wherein the memory stores a computer program which is executable by the controller to;
download from the remote database one or more templates into which at least some protocol data have been entered;
responsive to the protocol data, generate one or more prompt messages that prompt for the performance of one or more protocol elements, and that request performance data relating to any actual performance of the protocol elements;
display the prompt messages on the display; and
record and store in the memory any performance data received through the input device. - View Dependent Claims (20, 21)
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22. A machine-readable medium having stored therein instructions that, when executed by a computer, cause the computer to:
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download from the remote database one or more templates into which at least some protocol data have been entered;
responsive to the protocol data, generate one or more prompt messages that prompt for the performance of one or more protocol elements, and that request performance data relating to any actual performance of the protocol elements;
display the prompt messages on the display; and
record and store in the memory any performance data received through the input device.
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Specification