System for conducting clinical trials
First Claim
1. A method of conducting a clinical trial of a device or method or substance of treatment on a plurality of trial participants, the method including the steps of:
- establishing an electronic database in communication with one or more remote computers;
entering predetermined trial parameters of the conduct of the clinical trial into the database;
programming the database and remote computers to provide a predetermined interface for accepting predetermined information relating to the trial being entered by trial participants, administrators and/or auditors;
recording particulars of the trial participants and forming ordered registration information on the database;
forming randomised particulars of the trial participants in the database from the ordered registration information, the randomised particulars including the allocation of an identifier label;
assigning the device or method or substance of treatment to the randomised particulars of each trial participant;
entering trial data via the predetermined interface into the database by an authorized trial participant;
producing a report of data entered onto the database in response to predetermined reporting conditions;
controlling and tracking the ordering, allocation and dispensing of the device or method or substance of treatment and compiling a method or substance inventory record on the database; and
terminating the clinical trial in response to predetermined termination conditions.
1 Assignment
0 Petitions
Accused Products
Abstract
There is disclosed a system (1) for conducting a clinical trial of a pharmaceutical substance on a plurality of trial participants. The system (1) includes a central database (2) having a memory means in communication with a database means, one or more trial sites each having a remote computer (3) located remotely from the central database (2) and in communication therewith, the central database (2) being configured to receive predetermined parameters of the trial, both the central database (2) and the remote computers (3) being configured to receive predetermined trial data from one or more trial participants, the central database (2) being configured to control and track the ordering, allocation and dispensing of the pharmaceutical substances and compiling a pharmaceutical substance inventory record on the central database, and the central database (2) being configured to terminate the clinical trial in response to one or more predetermined trial termination conditions. A method of conducting a clinical trial of a pharmaceutical substance on a plurality of trial participants is also disclosed.
14 Citations
31 Claims
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1. A method of conducting a clinical trial of a device or method or substance of treatment on a plurality of trial participants, the method including the steps of:
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establishing an electronic database in communication with one or more remote computers;
entering predetermined trial parameters of the conduct of the clinical trial into the database;
programming the database and remote computers to provide a predetermined interface for accepting predetermined information relating to the trial being entered by trial participants, administrators and/or auditors;
recording particulars of the trial participants and forming ordered registration information on the database;
forming randomised particulars of the trial participants in the database from the ordered registration information, the randomised particulars including the allocation of an identifier label;
assigning the device or method or substance of treatment to the randomised particulars of each trial participant;
entering trial data via the predetermined interface into the database by an authorized trial participant;
producing a report of data entered onto the database in response to predetermined reporting conditions;
controlling and tracking the ordering, allocation and dispensing of the device or method or substance of treatment and compiling a method or substance inventory record on the database; and
terminating the clinical trial in response to predetermined termination conditions. - 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 system for conducting a clinical trial of a device or method or substance of treatment on a plurality of trial participants, the system including:
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a database having a memory means in communication with a database means;
one or more trial sites each having a remote computer located remotely from the database and in communication therewith;
the database being configured to receive predetermined parameters of the trial;
both the database and the remote computers being configured to receive predetermined trial data from one or more trial participants; and
the database being configured to control and track the ordering, allocation and dispensing of the device or method or substance of treatment and compiling a device or method or substance inventory record on the central database;
wherein the database being configured to terminate the clinical trial in response to one or more predetermined trial termination conditions. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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Specification