Systems and methods for clinical study management

• US 10,528,757 B2
• Filed: 11/30/2012
• Issued: 01/07/2020
• Est. Priority Date: 12/01/2011
• Status: Active Grant

• Current Assignee: Fahad Naveed
• Original Assignee: Fahad Naveed
• Inventors: Naveed, Fahad
• Primary Examiner(s): Kanaan, Simon P
• Application Number:
  US13/691,702
• Publication Number:
  US 20130145479A1
• Time in Patent Office: 2,594 Days
• 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 device for managing a medical chart comprising:

at least one processor; and

at least one memory storing computer-readable instructions, wherein the at least one processor is operable to access the at least one memory and execute the computer-readable instructions to;

store, on the at least one memory, one or more data records of the medical chart;

associate an access level with the one or more data records, the access level comprising;

a first access level associated with a first of the one or more data records,

a second access level associated with a second of the one or more data records, and

a third access level associated with a third of the one or more data records;

display the one or more data records based at least in part on the access level;

restrict modifications of the one or more data records based at least in part on the access level;

store, on the at least one memory, the modifications wherein storing the modifications comprises storing a current value, a prior value, and the access level of the one or more data records;

store, on the at least one memory, an auditor username and timestamp associated with the modifications; and

store, on the at least one memory, a current version and prior versions of the one or more data records, the current version comprising modified values of the one or more data records, the prior versions comprising all previous values of the one or more data records.

2. The device of claim 1, wherein the at least one memory comprises at least one remotely located memory.

3. The device of claim 1, wherein the computer-readable instructions are further operable to designate a prior version as the current version of the one or more data records, based on the user authentication.

4. The device of claim 1, wherein the computer-readable instructions are further operable to automatically update a price data record based at least in part on the modifications.

5. The device of claim 1, wherein the modifications are accepted via a touch-screen display.

18. The device of claim 1, wherein the computer-readable instructions are further operable to store at least two prior versions of the one or more data records in addition to the current version of the one or more data records.

19. The device of claim 3, wherein the current version of the one or more data records can be designated from one of at least two prior versions of the one or more data records.

20. The device of claim 1, wherein the computer-readable instructions are further operable to execute a billing process based at least in part on the modifications.

6. A method of charting and auditing medical information, the method comprising:

storing, on the at least one memory, one or more data records of the medical information;

associating an access level with the one or more data records of the medical information, the access level comprising;

a first access level associated with a first of the one or more data records;

a second access level associated with a second of the one or more data records; and

a third access level associated with a third of the one or more data records;

displaying the one or more data records based at least in part on the access level;

restricting modifications of the one or more data records based at least in part on the access level;

storing, on the at least one memory, the modifications wherein storing the modifications comprises storing modified values of the one or more data records and storing prior values of the one or more data records;

storing, on the at least one memory, an auditor username and timestamp associated with the modifications; and

storing, on the at least one memory, a current version and prior versions of the one or more data records, the current version comprising modified values of the one or more data records, the prior versions comprising all previous values of the one or more data records.

7. The method of claim 6, wherein the at least one memory comprises at least one remotely located memory.

8. The method of claim 6, further comprising updating a cost data record based on a modification.

9. The method of claim 6, further comprising associating the modifications with a unique version identifier, wherein the unique version identifier is stored on the at least one memory.

10. The method of claim 9, further comprising selecting a group of prior modifications, from two or more groups of prior modifications, wherein each of the two or more groups of prior modifications are associated with a unique version identifier.

11. A system for auditing an electronic medical chart, the system comprising:

at least one processor; and

at least one memory storing computer-readable instructions, wherein the at least one processor is operable to access the at least one memory and execute the computer-readable instructions to;

store, on the at least one memory, one or more data records of the electronic medical chart;

associate an access level with the one or more data records, the access level comprising;

a first access level associated with a first of the one or more data records,

a second access level associated with a second of the one or more data records, and

a third access level associated with a third of the one or more data records;

display the one or more data records based at least in part on the access level;

restrict modifications of the one or more data records, based at least in part on the access level;

store, on the at least one memory, the modifications wherein storing the modifications comprises storing modified values of the one or more data records and storing prior values of the one or more data records;

store, on the at least one memory, an auditor username and a timestamp associated with the modifications; and

store, on the at least one memory, a current version and prior versions of the one or more data records, the current version comprising modified values of the one or more data records, the prior versions comprising all previous values of the one or more data records.

12. The system of claim 11, wherein the at least one memory comprises at least one remotely located memory.

13. The system of claim 11, wherein the computer-readable instructions are further operable to automatically update a price data record based at least in part on the modifications.

14. The system of claim 11, wherein the display is further operable to receive input from a user.

15. The system of claim 11, wherein a group of modifications is associated with the username and the timestamp, and wherein a version identifier comprises the username and the timestamp.

16. The system of claim 11, wherein prior values of the one or more data records are available to be designated by a user as current values of the one or more data records, based at least in part on the access level.

17. The system of claim 11, wherein the display comprises a remotely located display.