CLINICAL TRIAL DATA CAPTURE
First Claim
1. A clinical trial data capture system comprising:
- a plurality of clinical site computers, each configured to be registered with a clinical trial site and having thick client software, anda server is configured to receive clinical data from the site computers and to analyse said data in real time, wherein at least one site computer;
includes location tracking capability and is configured to automatically upload location data to the server, and the server is configured to log said data,is configured to automatically upload patient site visit data to the server, and to also save site visit data to a document and to upload said document to the server, andhas a camera and is configured to capture an image related to a clinical visit and to upload said image with associated clinical visit data.
1 Assignment
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Accused Products
Abstract
A clinical trial data capture system has clinical site computers (6), each registered with a site and having thick client software, and a server (2) programmed to receive clinical data from the site computers and to analyse said data in real time. The server (2) automatically determines if a site computer is outside of an allowed region, indicating unauthorised use, and takes an action such as clearing the computer'"'"'s data. Each site computer performs cycle management by maintaining a workflow (14) per patient, and imposes a consent gate through to subsequent workflow stages of patient treatment with n visits V1 . . . Vi . . . Vn, and treatment follow-up. A distribution lplot is generated (27) for parameters when data is close to thresholds and a threshold may be automatically modified accordingly.
14 Citations
21 Claims
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1. A clinical trial data capture system comprising:
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a plurality of clinical site computers, each configured to be registered with a clinical trial site and having thick client software, and a server is configured to receive clinical data from the site computers and to analyse said data in real time, wherein at least one site computer; includes location tracking capability and is configured to automatically upload location data to the server, and the server is configured to log said data, is configured to automatically upload patient site visit data to the server, and to also save site visit data to a document and to upload said document to the server, and has a camera and is configured to capture an image related to a clinical visit and to upload said image with associated clinical visit data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A clinical trial data capture system comprising:
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a plurality of clinical site computers, each configured to be registered with a clinical trial site and having thick client software, and a server configured to receive clinical data from the site computers and to analyse said data in real time, wherein at least one site computer and/or the server are configured to automatically detect a medical adverse event by analysis of inputted patient data, wherein at least one site computer is configured to perform the following steps; receive an entry of a patient data, dynamically carry out a plausibility check by comparing the entered data with allowed ranges, and if the automatic analysis reveals that the patient candidate should not be accepted, but with only a small margin on some parameter, generate a distribution plot for this parameter over a number of candidates, and upload said distribution plot data to the server, and wherein the server is configured to then make a determination as to candidate eligibility and compares it to that made by the site computer.
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21. A clinical trial data capture system comprising:
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a plurality of clinical site computers, each configured to be registered with a clinical trial site and having thick client software, and a server configured to receive clinical data from the site computers and to analyse said data in real time, wherein at least one site computer is configured to download a batch of enrolment codes and of randomisation codes and store them locally, in which there is one code per patient, and to make said codes available even if the site computer is offline, and wherein at least one site computer is configured to automatically synchronize with a server when next online, by uploading which codes have been used; and
wherein at least one site computer is configured to automatically download a fresh batch of enrolment and randomisation codes during said synchronization,wherein at least one site computer is configured to, upon completion of a data entry, request a list of dispensing codes for the patient from the server or from an interactive response system, allowing only one dispensing code per bottle or packet of medication, and wherein at least one site computer is configured to capture a scanned identifier of medication physically provided to the patient, and the site computer and/or a server are configured to automatically check the scanned identifiers against inputted codes for the patient.
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Specification