System and method for managing medical data

• US 20070191721A1
• Filed: 02/14/2006
• Published: 08/16/2007
• Est. Priority Date: 02/14/2006
• Status: Active Grant

• Current Assignee: IQVIA, Inc. (IQVIA Holdings, Inc.)
• Original Assignee: Quintiles Transnational Corporation (IQVIA Holdings, Inc.)
• Inventors: Parker, Jason
• Granted Patent: US 7,689,439 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

According to various embodiments of the present invention, a data management process is provided that manages ECG data collection, review, and reporting in an efficient and secure manner by utilizing biometric checks, quality control measures, and workflow control systems that route data based on a variety of factors to efficiently complete the measurement and analysis process.

Claims

1. An automated system for facilitating conduct of clinical trials comprising,

(a) an initial quality control for receiving ECG data and patient information from a plurality of testing centers and comparing the ECG data and patient information with known patient information and set parameters;

(b) a technician workflow system for receiving the ECG data and information from a plurality of measurement technicians, automatically determining which technician should receive particular ECG data based on a plurality of factors, and sending the ECG data to the technician that is, based on the factors, best able to measure the ECG data; and

(c) a cardiologist workflow system for receiving the ECG data and information from a plurality of cardiologists, automatically determining which cardiologist should receive particular ECG data based on a plurality of factors, and sending the ECG data to the cardiologist that is, based on the factors, best able to analyze the ECG data.

2. The system of claim 1, further comprising a biometric signature after the initial quality control that requires an initial quality control technician to submit biometric data that is associated with the ECG data, wherein the biometric signature is associated with the ECG data record and is accessible in the future.

3. The system of claim 1, further comprising a biometric signature device to obtain a biometric signature after the measurement technician measures the ECG data and the cardiologist analyzes the ECG data that requires the signature as a condition to the measurement technician and cardiologist being authorized to save or send the data.

4. The system of claim 1, further comprising a post-analysis diagnosis system for comparing ECG data to predetermined parameters and sending a notification if the ECG data is outside the set parameters.

5. The system of claim 1, further comprising a quality review component adapted to review incoming ECG data and accompanying data, comparing that data to data expected to be received for various individuals being tested in the clinical trial, and sending a follow up message to a testing center if data about a particular individual has not been received by a certain time or date.

6. The system of claim 1 wherein the factors utilized by the technician workflow system comprise,

the amount of time left before the ECG data measurement and analysis is due to be completed;

and

the amount of time left on the shift of each technician on duty.

7. The system of claim 6, wherein the factors further comprise, the number of ECG data records waiting to be measured by each technician.

8. The system of claim 1 wherein the factors utilized by the cardiologist workflow system comprise,

the amount of time left before the ECG data measurement and analysis is due to be completed;

and

the amount of time left on the shift of each cardiologist on duty.

9. The system of claim 8, wherein the factors further comprise, the number of ECG data records waiting to be analyzed by each cardiologist.

10. The system of claim 1, further comprising the measurement workflow system for receiving ECG data marked by a cardiologist as incorrectly measured.

11. The system of claim 1, wherein the initial quality control is a processor-based device that electronically compares ECG data to set parameters.

12. A method for automating conduct of clinical trials, comprising:

(a) providing ECG data and accompanying data from a plurality of test centers;

(b) subjecting the ECG data to an initial quality control;

(c) automatically comparing the ECG data and accompanying data to known information or set parameters to determine if an error communication needs to be sent;

(e) sending ECG data that is correct to a measurement workflow system;

(f) automatically determining which measurement technician should receive the ECG data for measurement based on factors associated with the ECG data, accompanying data and information related to the plurality of measurement technicians;

(g) sending the ECG data to the measurement technician determined best able to measure the data;

(h) measuring the ECG data;

(i) receiving the ECG data, measurements, and information related to a plurality of cardiologists at a cardiologist workflow system;

(j) automatically determining which cardiologist should receive the ECG data and measurements for analysis based on factors associated with the ECG data and information related to the plurality of cardiologists;

(k) sending the ECG data to the cardiologist determined best able to analyze the ECG data and measurements; and

(m) analyzing the ECG data and measurements by the cardiologist and creating a report based on the results.

13. The method of claim 12, further comprising requiring a biometric signature after the initial quality control compares the ECG data to set parameters, wherein the biometric signature is associated with the ECG data record and is accessible in the future.

14. The method of claim 12, further comprising requiring a biometric signature after the measurement technician measures the ECG data and after the cardiologist analyzes the ECG data, wherein the biometric signature is a condition to the measurement technician and cardiologist being authorized to save or send the data.

15. The method of claim 12, further comprising providing a post-analysis diagnosis device for receiving ECG data from the cardiologist and comparing the ECG data to set values to provide additional quality control.

16. The method of claim 12, further comprising sending ECG data that was incorrectly measured back to the measurement workflow system for re-measurement.

17. The method of claim 12, further comprising sending data that is incorrect from the initial quality control to a testing site for correction.

18. The method of claim 12, wherein the initial quality control is a processor-based device that electronically compares ECG data to set parameters.

19. The method of claim 12, further comprising determining which measurement technician should receive the ECG data, wherein said factors include:

the amount of time left before the ECG data measurement and analysis is due to be completed; and

the amount of time left on the shift of each technician on duty.

20. The method of claim 19, wherein said factors further include the number of ECG data records waiting to be measured by each technician.

21. The method of claim 12, further comprising determining which cardiologist should receive the ECG data and measurements for analysis, wherein said factors include:

the amount of time left before the ECG data measurement and analysis is due to be completed; and

the amount of time left on the shift of each cardiologist on duty.

22. The method of claim 21, wherein the factors include the number of ECG data records waiting to be analyzed by each cardiologist.

23. A workflow system for facilitating a clinical trial data management comprising,

(a) a distribution queue for receiving ECG data and patient information and information related to a plurality of personnel from a plurality of personnel queues, determining which personnel is best able to measure or analyze the data based on factors associated with the ECG data and information related to a plurality of personnel, sending the ECG data to the personnel queue of the personnel that is best able to measure or analyze the data;

and

(b) a plurality of personnel queues for sending information related to the personnel to the distribution queue, receiving ECG data to be measured or analyzed by the personnel, and storing ECG data until the personnel selects the data for measurement or analysis.

24. The workflow system of claim 23, wherein the distribution queue is a processor-based device that electronically compares ECG data to set parameters.

25. The workflow system of claim 23, wherein the distribution queue is a processor based device for receiving data, determining, based on the data, which measurement or analysis personnel is best able to measure or analyze the data, and sending the ECG data.

26. The workflow system of claim 23, wherein said factors comprise,

the amount of time left before the ECG data measurement and analysis is due to be completed;

and

the amount of time left on the shift of pertinent personnel on duty.

27. The workflow system of claim 26, wherein said factors further comprise,

the number of ECG data records waiting to be analyzed by the pertinent personnel.

28. The workflow system of claim 23, wherein said personnel queues are processor-based devices for sending information about the personnel, receiving ECG data, and storing ECG data until the personnel is ready to measure or analyze the ECG data.