Systems and Methods for Clinical Trial Documenting Using a Mobile Communications Device
First Claim
1. A system for facilitating clinical trial documentation, the system comprising:
- a database including a non-transitory storage medium for storing clinical trial data; and
a processor in communication with the database, the processor executing instruction to perform stages comprising;
receiving, from a mobile communications device, a video clip of a participant administering a health intervention as part of a clinical trial;
associating the video clip with the participant by identifying the participant from amongst a plurality of participants based on an identifier received from the mobile communications device;
storing the video clip in the database in association with the first participant and the first administration; and
providing the video clip to a supervisory user to verify that the participant has complied with a requirement of the clinical trial.
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Accused Products
Abstract
Systems and methods presented herein may involve documenting clinical trials through use of a mobile communications device, such as a camera phone. Using the mobile communications device, the participant may record video of themselves administering a health intervention that is the subject of the clinical trial and/or report serious adverse events that occur. The video clips may be sent to a documentation server for documentation. The documentation server may also route serious adverse event notifications to a plurality of locations, such as the doctor'"'"'s office, the study center, and/or the pharmaceutical company that developed the health intervention being tested.
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Citations
20 Claims
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1. A system for facilitating clinical trial documentation, the system comprising:
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a database including a non-transitory storage medium for storing clinical trial data; and a processor in communication with the database, the processor executing instruction to perform stages comprising; receiving, from a mobile communications device, a video clip of a participant administering a health intervention as part of a clinical trial; associating the video clip with the participant by identifying the participant from amongst a plurality of participants based on an identifier received from the mobile communications device; storing the video clip in the database in association with the first participant and the first administration; and providing the video clip to a supervisory user to verify that the participant has complied with a requirement of the clinical trial. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A non-transitory computer-readable medium containing instructions that, when executed by a processor on a mobile communications device, cause the mobile communications device to perform steps including:
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display, on a screen of the mobile communications device; a first option to record video of an administration of a health intervention as part of a clinical trial; a second option to report a serious adverse event related to the clinical trial; and a third option to answer questions related to the clinical trial; receive a selection of the first option; record a video clip of the administration of the health intervention; connect to a documentation server that receives a plurality of video clips from a plurality of participants in the clinical trial; and transmit the video clip to the documentation server. - View Dependent Claims (10, 11)
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12. A non-transitory computer-readable medium containing instructions that, when executed by a processor on a mobile communications device, cause the mobile communications device to perform steps that include:
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displaying, on a screen of the mobile communications device, an option to record video documenting a participant'"'"'s compliance with a requirement of a clinical trial; receiving a selection of the option to record video; recording a video clip, using a camera component of the mobile communications device, of a participant complying with the requirement; wirelessly transmitting an identifier to the documentation server that the documentation server can use to identify the participant; and wirelessly transmitting the video clip to the documentation server for storage in a database in association with the identified participant. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20)
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Specification