METHOD, SYSTEM, AND APPARATUS FOR CLINICAL TRIAL MANAGEMENT OVER A COMMUNICATIONS NETWORK
First Claim
1. Within a centralized, online clinical study system, a method of coordinating a clinical study at a plurality of participating sites comprising:
- logging a user onto the clinical study system;
comparing workflows of the clinical study that are available through the clinical study system with workflows for which the user has been authorized;
restricting access to workflows of the clinical study for which the user has not been trained; and
providing online training to the user for a workflow or clinical trial activity for which the user has not been trained.
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Abstract
A centralized, online clinical study system configured to coordinate aspects of a clinical study can include a training module configured to evaluate whether users have completed training for selected workflows for the clinical study that are available from the clinical study system, and to provide training to registered users for the selected workflows. The system also can include a financial engine configured to determine when a participating site meets or exceeds a milestone of the clinical study and to initiate a payment to the participating site. Further, the system can include a module configured to receive and verify clinical research data and to designate the verified clinical research data as official source data for the clinical study.
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Citations
26 Claims
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1. Within a centralized, online clinical study system, a method of coordinating a clinical study at a plurality of participating sites comprising:
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logging a user onto the clinical study system; comparing workflows of the clinical study that are available through the clinical study system with workflows for which the user has been authorized; restricting access to workflows of the clinical study for which the user has not been trained; and providing online training to the user for a workflow or clinical trial activity for which the user has not been trained. - View Dependent Claims (2, 3)
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4. Within a centralized, online clinical study system, a method of coordinating a clinical study at a plurality of participating sites comprising:
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configuring the online clinical study system with a payment schedule of the clinical study; receiving clinical research data from participating sites via a communications network; comparing the clinical research data with the payment schedule of the clinical study; and if at least one criterion of the payment schedule has been met or exceeded, initiating an electronic payment to an account designated by the participating site from which the clinical research data was received. - View Dependent Claims (5, 6)
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7. Within a centralized, online clinical study system, a method of coordinating a clinical study at a plurality of participating sites comprising:
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receiving clinical research data pertaining to the clinical study; receiving a user input indicating that the information is complete; causing a summary of the clinical research data to be presented, whereby the user having provided the clinical research data can verify the accuracy of the clinical research data; receiving an additional user input indicating that the clinical research data is accurate; storing the clinical research data within a data store of the clinical study system; and designating the stored clinical research data as official electronic source data for the clinical study. - View Dependent Claims (8)
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- 9. A centralized, online clinical study system configured to coordinate aspects of a clinical study, said clinical study system comprising a training module configured to evaluate whether users have completed training for selected workflows for the clinical study that are available from the clinical study system, and provide training to registered users for the selected workflows.
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19. A machine readable storage, having stored thereon a computer program having a plurality of code sections executable by a machine for causing the machine to perform the steps of:
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logging a user onto a centralized, online clinical study system; comparing workflows of a clinical study that are available through the clinical study system with workflows for which the user has been authorized; restricting access to workflows of the clinical study for which the user has not been trained; and providing online training to the user for a workflow or clinical trial activity for which the user has not been trained. - View Dependent Claims (20, 21)
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22. A machine readable storage, having stored thereon a computer program having a plurality of code sections executable by a machine for causing the machine to perform the steps of:
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configuring a centralized, online clinical study system with a payment schedule of a clinical study; receiving clinical research data from participating sites via a communications network; comparing the clinical research data with the payment schedule of the clinical study; and if the at least one criterion of the payment schedule has been met or exceeded, initiating an electronic payment to an account designated by the participating site from which the clinical research data was received. - View Dependent Claims (23, 24)
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25. A machine readable storage, having stored thereon a computer program having a plurality of code sections executable by a machine for causing the machine to perform the steps of:
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receiving, within a centralized, online clinical study system, clinical research data pertaining to a clinical study; receiving a user input indicating that the clinical research data is complete; causing a summary of the clinical research data to be presented, whereby the user having provided the clinical research data can verify the accuracy of the clinical research data; receiving an additional user input indicating that the clinical research data is accurate; storing the clinical research data within a data store of the online clinical study system; and designating the stored clinical research data as official electronic source data for the clinical study. - View Dependent Claims (26)
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Specification