Systems and methods for enabling an untrained or novice end-user to rapidly build clinical trials data management systems compliant with all appropriate regulatory guidances
First Claim
1. A method for creating a customized database management system, the method comprising:
- providing a user with at least one question related to an anticipated use of the customized database management system;
receiving at least one answer to the at least one question from the user;
retrieving a set of rules associated with the anticipated use of the customized database management system;
analyzing the at least one answer and the set of rules; and
generating the customized database management system according to the analyzing of the at least one answer and the set of rules.
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Accused Products
Abstract
Systems and methods for enabling an untrained or novice end-user to rapidly build clinical trials data management systems that are compliant with all appropriate regulatory guidelines are disclosed. An exemplary embodiment is a software package, executed by a computer, that contains a specified knowledge base of clinical trials regulations and provides an interactive venue through which information and specifications for a particular clinical trial is collected by the user. The knowledge base of clinical trials regulations and the user-provided information are combined by the software to produce a set of “creation rules” unique to the particular clinical trial. The creation rules are then utilized by the software to automatically generate a clinical trials database management system, that is customized specifically to the particular clinical trial and adheres to the appropriate regulations that must govern the particular clinical trial.
36 Citations
20 Claims
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1. A method for creating a customized database management system, the method comprising:
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providing a user with at least one question related to an anticipated use of the customized database management system;
receiving at least one answer to the at least one question from the user;
retrieving a set of rules associated with the anticipated use of the customized database management system;
analyzing the at least one answer and the set of rules; and
generating the customized database management system according to the analyzing of the at least one answer and the set of rules. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A creation system for generating a customized database management system, the creation system comprising:
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a computer configured to execute a first routine for asking a user at least one question related to a desired application for the customized database management system and for receiving at least one answer to the at least one question from the user;
the computer further configured to execute a second routine for retrieving a set of rules associated with the desired application for the customized database management system;
the computer further configured to execute a third routine for processing an analysis of the at least one answer and the set of rules; and
the computer further configured to execute a fourth routine for generating the customized relational database management system according to the analysis. - View Dependent Claims (9, 10, 11, 12, 13, 14, 16, 17, 18, 19)
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15. A method for creating a clinical trials database management system, the method comprising:
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providing information descriptive of a particular clinical trial;
providing a first set of rules in accordance with clinical trials governing regulations;
generating a second set of rules that conforms to the information and to the first set of rules; and
generating the clinical trials database management system to be compliant with the second set of rules.
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20. Computer-readable storage media containing computer software that performs the following functions when loaded into and executed on a computer:
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presents to a user a question related to a desired application for a customized database management system;
receives from the user an answer to the question;
retrieves a set of rules associated with the desired application for the customized database management system;
analyzes the answer and the set of rules; and
generates the customized relational database management system according to the analysis.
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Specification