Systems and Methods for Clinical Study Management

• US 20130145479A1
• Filed: 11/30/2012
• Published: 06/06/2013
• Est. Priority Date: 12/01/2011
• Status: Active Grant

• Current Assignee: Fahad Naveed
• Original Assignee: Fahad Naveed
• Inventors: Naveed, Fahad
• Granted Patent: US 10,528,757 B2
• Time in Patent Office: Days
• US Class Current: 726/27
• CPC Class Codes: G06F 21/62 Protecting access to data via a platform, e.g. using keys or access control rules
• CPC Class Codes: G06F 21/6245 Protecting personal data, e.g. for financial or medical purposes
• CPC Class Codes: G06F 2221/2101 Auditing as a secondary aspect

Abstract

Electronic systems and methods for managing and auditing Clinical Trial data includes using storage and classification of all data. New data is added to the data storage system and designated as a current version, rather than deleting previous data and storing only a single version. Further identifying information about the data, including the user name who modified it and the date of modification, may also stored. Computer users are authenticated by the systems and methods and may then add and alter data according to user permissions. Further systems and methods include electronic billing for clinical trials based on statuses of clinical trial procedures. Prices for procedures may be assigned by appropriate users and billing mechanisms may proceed based on statuses of the procedures and not necessarily on the status of the entire clinical trial.

Claims

1. A method of electronically managing clinical trial data comprising:

authenticating a user to access a data management system;

displaying one or more items of data according to permissions of the user;

allowing modification of the one or more items according to permissions of the user;

storing in a data storage system a modification of the one or more items; and

retaining at least one prior value of the one or more items after the modification.

2. The method of claim 1 further comprising storing a name identifying the user.

3. The method of claim 1 further comprising storing a date and time of the modification.

4. The method of claim 1 further comprising storing a version identifier of the one or more items.

5. The method of claim 1 wherein retaining at least one prior value of the one or more items comprises retaining all prior values.

6. The method of claim 1 wherein storing a new value comprises creating a new record within the data storage system.

7. The method of claim 1 further comprising creating a medical chart wherein the medical chart is organized according to a criterion selected from the group consisting of patient-based organization, clinical study-based organization, and a combination of patient-based and clinical study-based organization.

8. A system of electronically managing clinical trial data comprising:

electronic authentication of a user;

one or more processors configured to display one or more items of clinical trial data according to permissions of the user;

one or more processors configured to allow modification of the one or more items according to permissions of the user; and

a data storage system comprising;

retention by a computer readable medium of at least one prior value of the one or more items; and

retention by a computer readable medium of the modification of the one or more items.

9. The system of claim 8 wherein retention of at least one prior value of the one or more items before modification comprises retention of all prior values of the one or more items before modification.

10. The system of claim 8 further comprising a document library comprised of forms selected from the group consisting of standardized medical forms, user-customized medical forms, and a combination of standardized and user-customized forms.

11. The system of claim 8 further comprising a medical chart comprising the clinical trial data and organized on a basis selected from the group consisting of patient data, study data, and a combination of patient and study data.

12. The system of claim 8 wherein the data storage system further comprises retention by a computer readable medium of a name identifying the user.

13. The system of claim 8 wherein the data storage system further comprises retention by a computer readable medium of a date and time of the modification.

14. The system of claim 8 wherein the data storage system further comprises retention by a computer readable medium of a version identifier of the one or more items.

15. The system of claim 8 wherein retention by a computer readable medium of the at least one prior value of the one or more items comprises retention of all prior values of the one or more items.

16. The system of claim 8 wherein retention by a computer readable medium of the modification of the one or more items comprises creating a new record within the data storage system.

17. A method of clinical trial billing comprising:

storing a price for a clinical trial procedure in a computer readable medium;

authenticating a user to access a clinical trial management system comprising the clinical trial procedure;

immediately upon completion of the clinical trial procedure,

configuring one or more processors to recognize the completion of the clinical trial procedure; and

communicating the price of the clinical trial procedure through a computer network to a designated recipient.

18. The method of claim 17 further comprising allowing the user to modify the price for the clinical trial procedure according to privileges of the user.

19. A system of clinical trial billing comprising:

a computer readable medium on which a data storage system comprises a price for a clinical trial procedure;

authentication of a user for access to a clinical trial management system comprising the clinical trial procedure;

one or more processors configured to recognize immediately completion of the clinical trial procedure; and

a computer network to communicate the price of the clinical trial procedure to a designated recipient.

20. The system of claim 19 further comprising modification of the price for the clinical trial procedure by the user according to privileges of the user.