Systems and methods for clinical trials information management
First Claim
1. A system for managing clinical trials, the system comprising:
- a Web client, wherein the Web client can access the Web via a Web browser;
a client;
a server, wherein the Web client can access the server via a Web connection and the client can access the server via a connection other than the Web connection; and
a patient records database, wherein the patient records database can be accessed by the server and the patient records database is logically partitioned and distributed based on a role in the clinical trials process of a user accessing the information.
1 Assignment
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Accused Products
Abstract
Embodiments of the present invention relate to systems and methods for managing clinical trials. A system for managing clinical trials includes a Web client, a client, a server, and a patient records database. The server provides a number of different applications a user can run, depending on their role in the clinical trials process. These applications are divided into core and non-core components. In an exemplary embodiment, there are twenty nine core and non-core components. Information from the patient records database is reported based on the role in the clinical trials process of the user accessing the information. Users with different roles are called stakeholders. Stakeholders include sponsor, regulator, investigator, site, patient, and monitor. Methods for reporting clinical trials information, monitoring clinical trial events, scheduling and tracking appointments, providing good clinical information, closing-out a trial, and displaying information to stakeholders are disclosed.
166 Citations
47 Claims
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1. A system for managing clinical trials, the system comprising:
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a Web client, wherein the Web client can access the Web via a Web browser;
a client;
a server, wherein the Web client can access the server via a Web connection and the client can access the server via a connection other than the Web connection; and
a patient records database, wherein the patient records database can be accessed by the server and the patient records database is logically partitioned and distributed based on a role in the clinical trials process of a user accessing the information. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method for reporting clinical trials information comprising:
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creating reporting requirements for a stakeholder;
extracting data from the system based on the reporting requirements;
validating the data against regulations and standards;
creating information from the data based on what is known about the stakeholder; and
displaying the information to the stakeholder. - View Dependent Claims (22)
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23. A method for monitoring events within a system for managing clinical trials, the method comprising:
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performing an event in a clinical trials protocol;
checking the event against business logic rules, industry regulations, and industry standards; and
alerting at least one stakeholder of the event.
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24. A method for scheduling and tracking appointments of a clinical trial subject comprising:
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designing a schedule of subject visits based on a clinical trial protocol;
enrolling a subject based on inclusion and exclusion criteria of the clinical trial protocol;
scheduling subsequent visits for the subject;
providing alerts that the enrolled subject should be sent reminders in advance of subsequent visits of the subject;
generating a checklist upon a visit by the subject;
documenting the checklist of items completed and not completed after the visit by the subject;
documenting cancelled and missed visits by the subject;
dropping the subject if a number of visits cancelled and missed exceeds a threshold;
notifying the subject when the number of visits cancelled and missed exceeds the threshold; and
documenting the dropping of the subject when the number of visits cancelled and missed exceeds the threshold. - View Dependent Claims (25, 26, 27, 28)
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29. A method for assuring good clinical information in scheduling and tracking the appointments of a clinical trial subject comprising:
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checking a designed schedule of subject visits for consistency with a clinical trial protocol and rules of informed consent;
collecting subject information in a manner compliant with industry regulations and standards;
checking the collected subject information against inclusion and exclusion criteria of business logic rules;
changing subject information coding to indicate enrolled and non-enrolled subjects;
checking lead time of a scheduled visit against all other scheduled visits for conflicts;
assuring that reminder calls are made and documented;
assuring that due diligence is shown and documented in regard to cancelled and missed visits by subjects;
assuring that proper methods are used to drop a subject from the clinical trial;
assuring the proper notice is given to a dropped subject; and
assuring the subject information of a dropped subject is properly identified in the system. - View Dependent Claims (31)
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30. A method for alerting and reporting in scheduling and tracking the appointments of a clinical trial subject comprising:
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generating subject instructions at time of scheduling a subject visit;
generating a checklist automatically at beginning of the subject visit;
notifying at least one stakeholder at the beginning of the subject visit;
alerting at least one stakeholder if a scheduled visit is missed or cancelled;
alerting at least one stakeholder before a scheduled subject visit;
generating a checklist to track proper compliance with follow-up procedures; and
alerting at least one stakeholder if the subject is dropped for exceeding a threshold of missed and cancelled visits.
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32. A method for producing good clinical information within a system for managing clinical trials, the method comprising:
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assuring that clinical information is collected in compliance with regulatory requirements;
assuring that the clinical information is collected in accordance with a proper organization workflow;
assuring that the clinical information is collected according to a clinical trial critical path;
assuring data integrity of the clinical information;
assuring the security of the clinical information; and
assuring the privacy of the clinical information. - View Dependent Claims (33, 34, 35, 36, 37)
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38. A method for closing-out a clinical trial comprising:
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providing a first report of treatment allocation for all enrolled subjects;
providing a second report on all used and unused investigational products;
locking a clinical trial database after completion of all case report forms;
performing a final analysis on the locked clinical trial database;
notifying at least one stakeholder of completion of the clinical trial; and
drafting a final clinical study report.
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39. A method for presenting information to stakeholders within a system for managing clinical trials, the method comprising:
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creating a digital dashboard for a stakeholder;
displaying a category of information common to all stakeholders on the digital dashboard; and
displaying a category of information specific to the stakeholder on the digital dashboard. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47)
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Specification