Methods and systems for managing clinical research information

• US 7,870,006 B2
• Filed: 09/23/2002
• Issued: 01/11/2011
• Est. Priority Date: 09/23/2002
• Status: Active Grant

• Current Assignee: General Electric Company
• Original Assignee: General Electric Company
• Inventors: Iatrou, Maria, Tkaczyk, John Eric, Rao, Naresh Kesavan
• Primary Examiner(s): Morgan; Robert W
• Assistant Examiner(s): NGUYEN, TRAN N
• Application Number:
  US10/065,159
• Publication Number:
  US 20040059597A1
• Time in Patent Office: 3,032 Days
• Field of Search: 705 2- 3
• US Class Current: 705/2
• 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 30/20 for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method for managing clinical study (CS) information for a clinical research entity using a server system coupled to a centralized database and at least one client system is provided. The centralized database has a plurality of templates stored therein. The method includes receiving at the server system CS information relating to at least one patient involved in a clinical study wherein the CS information is entered through a user selected template displayed on the client system, storing CS information received at the server system in the centralized database, tracking CS information stored in the centralized database, updating the centralized database periodically with newly received CS information to maintain CS information, and providing CS information in response to an inquiry.

Claims

1. A method for managing clinical study (CS) information for a clinical research entity via a server computer coupled to a centralized database and at least one client computer, said method comprising:

receiving at the server computer CS information relating to at least one patient involved in a clinical study, the CS information being entered through a user selected template displayed on the client computer, wherein the user selected template is selected from a plurality of templates stored in a centralized database, each of the plurality of templates configured to correspond to specific clinical studies;

storing CS information received at the server computer in the centralized database;

tracking CS information stared in the centralized database;

updating the centralized database periodically with newly received information to maintain CS information; and

providing CS information in response to an inquiry.

2. A method in accordance with claim 1 further comprising providing at least one medical device in communication with the at least one client computer, the at least one medical device includes at least one of a computed tomography device, a radiography device, a positron emission tomography device, and an ultrasound imaging device.

3. A method in accordance with claim 2 wherein receiving CS information comprises:

using a template selected by a user from the plurality of templates stored in the centralized database to gather protocols for operating the at least one medical device;

displaying the template on the client computer;

operating the at least one medical device based on the entered protocols; and

receiving at the server computer information generated as part of the operation of the at least one medical device including at least one of x-rays and diagnostic images for a patient involved in a clinical study.

4. A method in accordance with claim 1 further comprising transmitting from the server computer to the at least one client computer at least one report summarizing information and findings for a clinical study.

5. A method in accordance with claim 1 further comprising transmitting from the server computer to the at least one client computer at least one report summarizing CS information and findings for at least one patient involved in a clinical study.

6. A method in accordance with claim 1 wherein receiving CS information comprises:

using a template selected by a user from the plurality of templates stored within the centralized database to gather CS information;

displaying the selected template on the client computer; and

inputting into the selected template at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents and information relating to the treatment and/or diagnosis patient involved in a clinical study conducted by the clinical research entity.

7. A method in accordance with claim 1 wherein tracking CS information comprises:

compiling a data report including at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient 1D number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information relating to utilized medical equipment, engineering information relating to utilized medical equipment, marketing information relating to utilized medical equipment, and any other information relating to the treatment and/or diagnosis of a patient involved in a clinical study, conducted by the clinical research entity; and

transmitting the data report to a predesignated party at the at least one client computer.

8. A method in accordance with claim 1 wherein tracking CS information comprises exporting CS information selected by a user to at least one computer program.

9. A method in accordance with claim 1 wherein tracking CS information further comprises:

linking to a specific patient involved in a clinical study at least one of a patient medical history, utilized medical application information, utilized medical equipment information, treatment diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents and information relating to the treatment and/or diagnosis of the patient; and

displaying on the client computer at least one of the patient medical history, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of the patient.

10. A method in accordance with claim 1 wherein providing CS information comprises:

displaying on the client computer at least one of a list of patients involved in a clinical study and a list of clinical studies conducted by the clinical research entity;

receiving an inquiry from the client computer regarding at least one of a patient included within the patient list and a clinical study included within the clinical study list.

11. A method in accordance with claim 1 wherein providing CS information comprises:

receiving an inquiry from the client computer regarding at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of a patient involved in a clinical study conducted by the clinical research entity; and

displaying information on the client computer regarding at least one of the patient name, the patient sex, the patient medical history, the patient weight, the patient height, the patient age, the patient ID number, the modality of treatment diagnosis, utilized medical application information, utilized medical equipment information, treatment diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of the patient.

12. A method in accordance with claim 1 wherein providing CS information comprises:

accessing the centralized database;

searching the database regarding the specific inquiry;

retrieving information from the database; and

transmitting the retrieved information to the client computer for display by the client computer,

13. A method in accordance with claim 1 further comprising connecting the client computer and the server computer via a network that includes one of a wide area network, a local area network, an intranet and the Internet.

14. A method tor managing clinical study (CS) information for a clinical research entity via a server computer coupled to a centralized database and at least one client computer, the at least one client computer in communication with at least one medical device, said method comprising:

using a template selected by a user from a plurality of templates stored in a centralized database to gather protocols for acquisition of image data via the at least one medical device, each of the plurality of templates configured to correspond to specific clinical studies;

operating the at least one medical device for acquiring image data based on the entered protocols;

receiving at the server computer CS information that relates to at least one patient involved in a clinical study, the CS information being entered through the user selected template displayed on the client computer and being generated as part of the operation of the at least one medical device including acquisition of diagnostic images;

storing CS information received at the server computer in the centralized database;

tracking CS information stored in the centralized database;

updating the centralized database periodically with newly received CS information to maintain CS information;

providing CS information in response to an inquiry; and

transmitting from the server computer to the at least one client computer at least one report relating to CS information and findings for at least one of a clinical study and a patient involved in a clinical study.

15. A method in accordance with claim 14 further comprising providing at least one medical device including at least one of a computed tomography device, a radiography device, a positron emission tomography device, and an ultrasound imaging device.

16. A method in accordance with claim 14 wherein receiving CS information comprises:

receiving at the server computer at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of a patient involved in a clinical study conducted by the clinical research entity.

17. A network based system for managing clinical study (CS) information, said system comprising:

a client computer comprising a browser;

a centralized database, stored on a tangible computer-readable medium, for storing information and a plurality of templates; and

a server computer configured to be coupled to said client computer and said database, said server computer further configured to;

receive CS information relating to at least one patient involved in a clinical study, said CS information being entered through a user selected template displayed on said client computer, wherein the user selected template is selected from the plurality of templates stored in the centralized database, each of the plurality of templates configured to correspond to specific clinical studies;

store CS information in said centralized database;

track CS information;

update said centralized database periodically with newly received CS information to maintain CS information; and

provide CS information in response to an inquiry by a user.

18. A system in accordance with claim 17 further comprising at least one medical device in communication with said client computer and said server computer, said at least one medical device including at least one of a computed tomography device, a radiography device, a positron emission tomography device, and an ultrasound imaging device.

19. A system in accordance with claim 18 wherein said server computer further comprises a receiving component that:

uses a template selected by a user from said plurality of templates stored in said centralized database to gather protocols for operating said at least one medical device;

displays said selected template on said client computer;

operates said at least one medical device based on said entered protocols; and

receives CS information generated as part of the operation of said at least one medical device including at least one of x-rays and diagnostic images for a patient involved in a clinical study.

20. A system in accordance with claim 17 wherein said server computer is further configured to transmit to said client computer at least one report summarizing CS information and findings for a clinical study.

21. A system in accordance with claim 17 wherein said server computer is further configured to transmit to said client computer at least one report summarizing CS information and findings for at least one patient involved in a clinical study.

22. A system in accordance with claim 17 wherein said server computer further comprises a receiving component that:

uses a template selected by a user from said plurality of templates stored in said centralized database to gather CS information;

displays said selected template on said client computer; and

receives through said selected template at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient-age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application, information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents and information relating to the treatment and/or diagnosis of a patient involved in a clinical study conducted by the clinical research entity.

23. A system in accordance with claim 17 wherein said server computer further comprises a tracking component that;

compiles a data report including at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information relating to utilized medical equipment, engineering information relating to utilized medical equipment, marketing information relating to utilized medical equipment, and any other information relating to the treatment and/or diagnosis of a patient involved in a clinical study conducted by the clinical research entity; and

transmits said data report to a predesignated party at said client computer.

24. A system in accordance with claim 17 wherein said server computer further comprises a tracking component that exports CS information selected by a user to at least one computer program.

25. A system in accordance with claim 17 wherein said server computer further comprises a tracking component that;

links to a specific patient involved in a clinical study at least one of a patient medical history, utilized medical application-information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents and information relating to the treatment and/or diagnosis of said patient; and

displays on said client computer at least one of said patient medical history, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of said patient.

26. A system in accordance with claim 17 wherein said server computer further comprises a providing component that:

displays on said client computer at least one of a list of patients involved in a clinical study and a list of clinical studies conducted by the clinical research entity; and

receives an inquiry from said client computer regarding at least one of a patient included within said patient list and a clinical study included within said clinical study list.

27. A system in accordance with claim 17 wherein said server computer further comprises a providing component that:

receives an inquiry from said client computer regarding at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of a patient involved in a clinical study conducted by the clinical research entity; and

displays information on said client computer regarding at least one of said patient name, said patient sex, said patient medical history, said patient weight, said patient height, said patient age, said patient ID number, said modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of said patient.

28. A system in accordance with claim 17 wherein said server computer further comprises a providing component that:

accesses said centralized database;

searches said database regarding a specific inquiry;

retrieves information from said database; and

transmits said retrieved information to said client computer for display by said client system computer.

29. A system in accordance with claim 17 wherein said server computer, said client computer, and said database we connected via a network that includes one of a wide area network, a local area network, an intranet and the Internet.

30. A network based system for managing clinical study (CS) information, said system comprising:

a client computer comprising a browser;

at least one medical device in communication with said client computer;

a centralized database, stored on a tangible computer-readable medium, for storing information and a plurality of templates; and

a server computer configured to he coupled to said client computer and said database, said server computer further configured to;

use a template selected by a user from the plurality of templates stored in the centralized database to gather protocols for acquisition of image data via the at least one medical device, each of the plurality of templates configured to correspond to specific clinical studies;

operate said at least one medical device for acquiring image data based on said entered protocols;

receive CS information relating to at least one patient involved in a clinical study, said CS information entered through a user selected template displayed on said client computer and generated as part of the operation of said at least one medical device including acquisition of diagnostic images;

store CS information in said centralized database;

track CS information;

update said centralized database periodically with newly received CS information to maintain CS information;

provide CS information in response to an inquiry; and

transmit to said client computer at least one report relating to CS information and findings for at least one of a clinical study and a patient involved in a clinical study.

31. A system in accordance with claim 30 wherein said at least one medical device comprises at least one of a computed tomography device, a radiography device, a positron emission tomography device, and an ultrasound imaging device.

32. A system in accordance with claim 30 wherein said server commuter further comprises a receiving component that:

receives at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of a patient involved in a clinical study conducted by the clinical research entity.

33. A computer program embodied on a non-transitory computer readable medium for managing clinical study (CS) information, said program comprising a code segment that;

receives CS information relating to at least one patient involved in a clinical study through a user selected template displayed on a client computer, wherein the user selected template is selected from a plurality of templates stored in a centralized database, each of the plurality of templates configured to correspond to specific clinical studies;

maintains a database by adding, deleting and updating CS information;

tracks CS information;

provides CS information in response to an inquiry by a user; and

transmits to said client computer at least one report summarizing CS information and findings relating to at least one of a clinical study and a patient involved in a clinical study.

34. A computer program in accordance with claim 33 further comprising a code segment that enables at least one medical device to communicate with said client computer wherein said at least one medical device includes at least one of a computed tomography device, a radiography device, a positron emission tomography device, and an ultrasound imaging device.

35. A computer program in accordance claim 34 further comprising a code segment that:

displays a template selected by a user on said client computer;

uses said selected template to gather protocols for operating said at least one medical device;

operates said at least one medical device based on said entered protocols; and

receives CS information generated as part of the operation of said at least one medical device including at least one of x-rays and diagnostic images.

36. A computer program in accordance with claim 33 further comprising a code segment that:

displays a template selected by a user on said client computer;

uses said selected template to gather US information; and

receives through said selected template at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents and information relating to the treatment and/or diagnosis of a patient involved in a clinical study conducted by the clinical research entity.

37. A computer program in accordance with claim 33 further comprising a code segment that:

compiles a data report including at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information relating to utilized medical equipment, engineering information relating to utilized medical equipment, marketing information relating to utilized medical equipment, and any other information relating to the treatment and/or diagnosis of a patient involved in a clinical study conducted by the clinical research entity; and

transmits said data report to a predesignated party at said client computer.

38. A computer program in accordance with claim 33 further comprising a code segment that:

links to a specific patient involved in a clinical study at least one of a patient medical history, medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents and information relating to the treatment and/or diagnosis of said patient; and

displays on said client computer at least one of said patient medical history, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays;

manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of said patient.

39. A computer program in accordance with claim 33 further comprising a code segment that:

displays on said client computer at least one of a list of patients involved in a clinical study and a list of clinical studies conducted by the clinical research entity; and

receives an inquiry from said the client computer regarding at least one of a patient included within said patient list and a clinical study included within said clinical study list.

40. A computer program in accordance with claim 33 further comprising a code segment that:

receives an inquiry from said client computer regarding at least one of a patient name, a patient sex, a patient medical history, a patient weight, a patient height, a patient age, a patient ID number, a modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of the patient involved in a clinical study conducted by the clinical research entity; and

displays information on said the client computer regarding at least one of said patient name, said patient sex, said patient medical history, said patient weight, said patient height, said patient age, said patient ID number, said modality of treatment and/or diagnosis, utilized medical application information, utilized medical equipment information, treatment and/or diagnosis results, modeled images, x-rays, manufacturing information and documents relating to utilized medical equipment, engineering information and documents relating to utilized medical equipment, marketing information and documents relating to utilized medical equipment, and any other documents or information relating to the treatment and/or diagnosis of said patient.