SYSTEMS AND METHODS FOR MANAGING PATIENT RESEARCH DATA
First Claim
1. A system for use in clinical trial,wherein a mobile device is used for registration process of a subject for said clinical trial,wherein a biometric consent process is included that provides obtaining one or more pieces of biometric information via said mobile device,wherein the subject is able to provide a signature on said mobile device, that generates a signed informed consent form, andwherein said informed consent form is mapped directly to the said subject'"'"'s profile.
1 Assignment
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Accused Products
Abstract
The disclosure is directed to a process and system for managing the end-to-end process of obtaining research data from patients and/or participants in a Clinical Trial. The process enables collection of appropriate informed consent from patient/participants via electronic devices such as smart phones and tablets. Additionally, the system uses biometric information such as finger prints, face pictures, digital signature to provide additional information concerning a participant. This helps to make the whole informed consent process effortless, paperless and transparent. An aspect of the disclosure enables investigators to reach out to a wider patient/participant population irrespective of their physical location. Thus the platform enables investigators to collect and transfer real time data, seamlessly from across the world.
10 Citations
17 Claims
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1. A system for use in clinical trial,
wherein a mobile device is used for registration process of a subject for said clinical trial, wherein a biometric consent process is included that provides obtaining one or more pieces of biometric information via said mobile device, wherein the subject is able to provide a signature on said mobile device, that generates a signed informed consent form, and wherein said informed consent form is mapped directly to the said subject'"'"'s profile.
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9. A system for use in clinical trial,
wherein said system is able to capture subject data and monitor progress remotely, on an ongoing basis throughout the duration of a clinical trial, wherein said subject data is collected directly from said subject with verification of the said subject'"'"'s identity, wherein said system enables data flow management between the study sites, said subjects and the investigators. wherein said subject data is captured directly into a mobile device.
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14. A system for use in clinical trial,
wherein said system is configurable to allow a mobile device to integrate subject data captured from medical devices, wherein said subject data is stored in said subject'"'"'s visit profile, and directly fed to a cloud-based server, wherein said subject data is seamlessly accessed by investigators.
Specification