Methods and apparatus for the centralized collection and validation of geographically distributed clinical study data with verification of input data to the distributed system
DCFirst Claim
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1. A computer-based method for centralized collection of geographically distributed information from at least one user at a remote site computer, comprising:
- obtaining data from a clinical trial;
receiving said clinical trial data from the at least one user with the remote site computer;
checking the data for validity with the remote site computer;
providing the user an opportunity to correct any invalid data found during the checking;
transmitting the data to a centralized computer over a transmission medium;
receiving and validating the data from the remote site computer at the centralized computer, including comparing the data to data already stored at the centralized computer to determine if it is valid or invalid;
if the data from the remote site computer is determined to be invalid, then performing the following until all data is determined to be valid;
signaling with the centralized computer to the remote site computer to provide the user an opportunity to correct invalid data;
transmitting corrected data from the remote site computer to the centralized computer; and
receiving and validating the corrected data from the remote site computer at the centralized computer, including comparing the corrected data to data already stored at the centralized computer to determine if the data is valid or invalid;
when all data has been determined to be valid, then entering and storing the valid data in a central database at the centralized computer.
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Abstract
The centralized collection of geographically distributed data is accomplished using a system which takes advantage of an interactive programming language, such as Java® and existing wide area networks, such as the Internet including the world wide web (4), to collect high quality data in an information center (10). The information center being connected to remote sites (1) through the wide area network. One or more levels of validation of the data prior to storage in a database is provided for.
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Citations
30 Claims
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1. A computer-based method for centralized collection of geographically distributed information from at least one user at a remote site computer, comprising:
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obtaining data from a clinical trial;
receiving said clinical trial data from the at least one user with the remote site computer;
checking the data for validity with the remote site computer;
providing the user an opportunity to correct any invalid data found during the checking;
transmitting the data to a centralized computer over a transmission medium;
receiving and validating the data from the remote site computer at the centralized computer, including comparing the data to data already stored at the centralized computer to determine if it is valid or invalid;
if the data from the remote site computer is determined to be invalid, then performing the following until all data is determined to be valid;
signaling with the centralized computer to the remote site computer to provide the user an opportunity to correct invalid data;
transmitting corrected data from the remote site computer to the centralized computer; and
receiving and validating the corrected data from the remote site computer at the centralized computer, including comparing the corrected data to data already stored at the centralized computer to determine if the data is valid or invalid;
when all data has been determined to be valid, then entering and storing the valid data in a central database at the centralized computer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
wherein the checking the data for validity with the remote site computer comprises checking the data as it is entered in a field by the user; and
wherein the providing the user an opportunity to correct any invalid data found during the checking comprises signaling the user that data entered in a field may be invalid.
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3. The method according to claim 2, wherein the checking the data for validity with the remote site computer comprises checking the data after data has been entered by the user into all fields of the form.
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4. The method according to claim 1, wherein the transmitting the data to a centralized computer over a transmission medium comprises:
sending the data from the remote site computer to the centralized computer via the internet.
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5. The method according to claim 1, wherein the method further comprises:
establishing a connection between the remote site computer and the centralized computer via the internet using a browser having interface filter plug-ins.
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6. The method according to claim 5, wherein the interface filter plug-ins provide the checking the data for validity with the remote site computer.
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7. The method according to claim 5, wherein the receiving and validating the data from the remote site computer to determine if the data is valid or invalid is performed using interface filter scripts.
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8. The method according to claim 5, wherein the remote site computer and the centralized computer are programmed to perform the method using a programming language optimized for use with the browser, suitable for interactive applications, platform independent, relatively concise and downloadable through a browser.
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9. The method according to claim 8, wherein the programming language comprises JAVA®
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10. The method according to claim 1, wherein the user can customize the database fields and format.
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11. A computer-based system to gather, transmit, and store geographically distributed information comprising:
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input means for entry of information at a remote site;
an information center having receiving means for receiving and storing the information;
transmission means for transmitting the entered information to the receiving means from the remote site input means;
first verification means at the remote site for verifying the information for accuracy as the information is being entered with the input means;
second verification means at the information center for verifying the information received from the remote site input means by comparing the information with information previously stored at the information center;
wherein at least one of the first verification means and the second verification means comprises means for verifying the information for accuracy as clinical trial data against a predetermined clinical trial data variable. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A computer system for clinical trial management of centralized collection of geographically distributed information, comprising:
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a remote site computer having a browser with a first data verification module for verifying data entered at the remote, site computer;
a transmission medium coupled to the remote site computer; and
a central computer coupled to the transmission medium, and having a database and a second data verification module for verifying data received from the remote site computer;
wherein at least one of the first verification module and the second verification module comprises means for verifying the information for accuracy as clinical trial data against a predetermined clinical trial data variable. - View Dependent Claims (26, 27)
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28. An interactive computer web-enabled method for use in clinical trial research using centralized collection of geographically distributed information from at least one user at a remote site computer, comprising:
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obtaining data from a clinical trial;
receiving said data from the at least one user with the remote site computer;
checking the data for validity with the remote site computer;
providing the user an opportunity to correct any invalid data found during the checking;
transmitting the data to a centralized computer over a transmission medium;
receiving and validating the data from the remote site computer at the centralized computer, including comparing the data to data already stored at the centralized computer to determine if it is valid or invalid;
if the data from the remote site computer is determined to be invalid, then performing the following until all data is determined to be valid;
signaling with the centralized computer to the remote site computer to provide the user an opportunity to correct invalid data;
transmitting corrected data from the remote site computer to the centralized computer; and
receiving and validating the corrected data from the remote site computer at the centralized computer, including comparing the corrected data to data already stored at the centralized computer to determine if the data is valid or invalid;
when all data has been determined to be valid, then entering, storing, and providing physicians real time access to the valid data in a central database at the centralized computer to allow them to react quickly to the patient'"'"'s symptoms.
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29. A web-enabled clinical trial management system for gathering, transmitting, and storing geographically distributed information comprising:
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input means for entry of information at a remote site;
an information center having receiving means for receiving and storing information;
transmission means for transmitting the entered information to the receiving means from the remote site input means;
first verification means at the remote site for verifying the information for accuracy as the information is being entered with the input means; and
second verification means at the information center for verifying the information received from the remote site input means by comparing the information with information previously stored at the information center;
wherein at least one of the first verification means and the second verification means comprises means for verifying the information for accuracy as clinical trial data against a predetermined clinical trial data variable. - View Dependent Claims (30)
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Specification