Methods and systems for data analysis

• US 10,276,054 B2
• Filed: 11/29/2012
• Issued: 04/30/2019
• Est. Priority Date: 11/29/2011
• Status: Active Grant

• Current Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Original Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Inventors: Eger, Jason, McClelland, Jon, Peterson, Dave
• Primary Examiner(s): Utama, Robert J
• Application Number:
  US13/688,962
• Publication Number:
  US 20130157244A1
• Time in Patent Office: 2,343 Days
• CPC Class Codes: G06Q 30/02 Marketing; Price estimation or determination; Fundraising
• CPC Class Codes: G09B 7/00 Electrically-operated teaching apparatus or devices working with questions and answers mechanically operated G09B3/00; computing arrangements G06F
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

Abstract

Provided herein are systems, methods, and computer readable medium for entering, identifying, and aggregating data for analysis data in an electronic device, wherein the data are from a plurality of multi-participant surveys.

Claims

1. A method for enhancing function of an electronic device in a clinical trial, the method comprising:

a. receiving, by the electronic device, first clinical trial data associated with a first participant in a first clinical trial;

b. communicating, by the electronic device, first data to one or more servers over a network, the first data comprising the first clinical trial data, first compliance data associated with the first clinical trial data, first subject identification information identifying the first participant, or first study identification information identifying the first clinical trial;

c. receiving, by the electronic device, second clinical trial data associated with a second participant in a second clinical trial;

d. communicating, by the electronic device, second data to the one or more servers over the network, the second data comprising the second clinical trial data, second compliance data associated with the second clinical trial data, second subject identification information identifying the second participant, or second study identification information identifying the second clinical trial;

e. generating and storing, by the one or more servers, a first data structure and a second data structure in a staging data repository, wherein the first data structure is based at least on the first data, and wherein the second data structure is based at least on the second data;

f. sifting, by the one or more servers, data structures from the staging data repository into a plurality of study data repositories, wherein the plurality of study data repositories comprises a first study data repository associated with the first clinical trial and a second study data repository associated with the second clinical trial and wherein the sifting comprises;

transferring, by the one or more servers, the first data structure to the first study data repository; and

transferring, by the one or more servers, the second data structure to the second study data repository;

g. locking, by the one or more servers, the first study data repository; and

h. preventing, by the one or more servers based at least on a determination that the first study data repository is locked, a third data structure from being transferred to the first study data repository; and

transferring, by the one or more servers, a fourth data structure to the second study data repository.

2. The method of claim 1, further comprising recording the first clinical trial data and the second clinical trial data on the electronic device.

3. The method of claim 1, wherein the electronic device is connected to Internet.

4. The method of claim 1, wherein the first participant enters the first clinical trial data into the electronic device, and the second participant enters the second clinical trial data into the electronic device.

5. The method of claim 1, wherein a first individual enters the first clinical trial data into the electronic device, and a second individual enters the second clinical trial data into the electronic device.

6. The method of claim 1, further comprising entering data from at least 3 clinical trials into the electronic device.

7. The method of claim 1, wherein the electronic device is in electronic communication with the staging data repository.

8. The method of claim 1, further comprising receiving, by the one or more servers, third data from the electronic device over the network, the third data comprising third clinical trial data associated with the first participant in the first clinical trial, third compliance data associated with the third clinical trial data, the first subject identification information, or the first study identification information.

9. The method of claim 1, further comprising receiving, by the one or more servers, fourth data from the electronic device over the network, the fourth data comprising fourth clinical trial data associated with the second participant, fourth compliance data associated with the fourth clinical trial data, the second subject identification information, or the second study identification information.

10. The method of claim 7, wherein the staging data repository is in electronic communication with the plurality of study data repositories.

11. The method of claim 8, further comprising storing, by the one or more servers, a third data structure in the staging data repository, wherein the third data structure is based at least on the third data.

12. The method of claim 9, further comprising storing, by the one or more servers, a fourth data structure in the staging data repository, wherein the fourth data structure is based at least on the fourth data.

13. The method of claim 10, further comprising adding a new study data repository to the plurality of study data repositories, wherein the new study data repository is in electronic communication with the staging data repository.

14. The method of claim 10, wherein the plurality of study data repositories comprise at least 3 study data repositories.

15. The method of claim 1, further comprising providing the electronic device to a site, wherein a plurality of participants communicates with the site.

56. The method of claim 1, further comprising assessing validity of the first data or the second data.

57. The method of claim 56, further comprising performing an action based on the validity of the first data or the second data.

58. The method of claim 57, wherein the action comprises providing a message to the first participant, the second participant, a clinical trial staff, or a sponsor.

59. The method of claim 58, wherein the message is feedback.

60. The method of claim 57, wherein the action comprises excluding the first data or excluding the second data.

79. The method of claim 1, wherein the electronic device is a personal computer, minicomputer, mainframe, multiprocessor system, network computer, processor-based electronic device, desktop computer, laptop computer, PC computer, Macintosh computer, notebook computer, netbook computer, e-reader, tablet computer, or tablet PC.

80. The method of claim 79, wherein the electronic device comprises a tablet computer.

81. The method of claim 1, wherein the electronic device comprises a handheld electronic device.

82. The method of claim 1, wherein the electronic device comprises one or more visual, audible, or tactile features for communicating with the first participant or the second participant.

95. The method of claim 1, wherein the second participant is in the second clinical trial, and wherein the first participant and the second participant are the same person.

96. The method of claim 1, the first participant and the second participant are different people.

16. A non-transitory computer readable medium having stored thereon sequences of instructions, which, when executed by one or more computer processors of a computer system, cause the computer system to perform:

a. receiving, by an electronic device, first clinical trial data associated with a first participant in a first clinical trial;

b. communicating, by the electronic device, first data to one or more servers over a network, the first data comprising the first clinical trial data, first compliance data associated with the first clinical trial data, first subject identification information identifying the first participant, or first study identification information identifying the first clinical trial;

c. receiving, by the electronic device, second clinical trial data associated with a second participant in a second clinical trail;

d. communicating, by the electronic device, second data to the one or more servers over the network, the second data comprising the second clinical trial data, second compliance data associated with the second clinical trial data, second subject identification information identifying the second participant, or second study identification information identifying the second clinical trial;

e. generating and storing by the one or more servers, a first data structure and a second data structure in a staging data repository, wherein the first data structure is based at least on the first data, and wherein the second data structure is based at least on the second data;

f. sifting, by the one or more servers, data structures from the staging data repository into a plurality of study data repositories, wherein the plurality of study data repositories comprises a first study data repository associated with the first clinical trial and a second study data repository associated with the second clinical trial and wherein the sifting comprises;

transferring, by the one or more servers, the first data structure to the first study data repository; and

transferring, by the one or more servers, the second data structure to the second study data repository;

g. locking, by the one or more servers, the first study data; and

h. preventing, by the one or more servers based at least on a determination that the first study data repository is locked, a third data structure from being transferred to the first study data repository; and

transferring, by the one or more servers, a fourth data structure to the second study data repository.

19. The non-transitory computer readable medium of claim 16, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform recording the first clinical trial data and the second clinical trial data on the electronic device.

20. The non-transitory computer readable medium of claim 16, wherein the electronic device is connected to the Internet.

21. The non-transitory computer readable medium of claim 16, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform accepting the first clinical trial data into the electronic device, and accepting the second clinical trial data into the electronic device.

22. The non-transitory computer readable medium of claim 16, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform accepting from a first individual the first clinical trial data into the electronic device, and accepting from a second individual the second clinical trial data into the electronic device.

23. The non-transitory computer readable medium of claim 16, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform accepting data from at least 3 clinical trials into the electronic device.

24. The non-transitory computer readable medium of claim 16, wherein the electronic device is in electronic communication with the staging data repository.

25. The non-transitory computer readable medium of claim 16, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform receiving, by the one or more servers, third data from the electronic device over the network, the third data comprising third clinical trial data associated with the first participant in the first clinical trial, third compliance data associated with the third clinical trial data, the first subject identification information, or the first study identification information.

26. The non-transitory computer readable medium of claim 16, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform receiving, by the one or more servers, fourth data from the electronic device over the network, the fourth data comprising fourth clinical trial data associated with the second participant, fourth compliance data associated with the fourth clinical trial data, the second subject identification information, or the second study identification information.

27. The non-transitory computer readable medium of claim 24, wherein the staging data repository is in electronic communication with the plurality of study data repositories.

28. The non-transitory computer readable medium of claim 25, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform storing, by the one or more servers, a third data structure in the staging data repository, wherein the third data structure is based at least on the third data.

29. The non-transitory computer readable medium of claim 26, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform storing, by the one or more servers, a fourth data structure in the staging data repository, wherein the fourth data structure is based at least on the fourth data.

30. The non-transitory computer readable medium of claim 27, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, cause the computer system to perform adding a new study data repository to the plurality of study data repositories, wherein the new study data repository is in electronic communication with the staging data repository.

31. The non-transitory computer readable medium of claim 27, wherein the plurality of study data repositories comprise at least 2 study data repositories.

61. The non-transitory computer readable medium of claim 16, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, causes the computer system to assess validity of the first data or the second data.

62. The non-transitory computer readable medium of claim 61, further comprising stored thereon sequences of instructions, which, when executed by the one or more computer processors of the computer system, causes the computer system to perform an action based on the validity of the first data or the second data.

63. The non-transitory computer readable medium of claim 62, wherein the action comprises providing a message to the first participant, the second participant, a clinical trial staff, or a sponsor.

64. The non-transitory computer readable medium of claim 63, wherein the message is feedback.

65. The non-transitory computer readable medium of claim 62, wherein the action comprises excluding the first data or excluding the second data.

83. The non-transitory computer readable medium of claim 16, wherein the electronic device comprises a personal computer, minicomputer, mainframe, multiprocessor system, network computer, processor-based electronic device, desktop computer, laptop computer, PC computer, Macintosh computer, notebook computer, netbook computer, e-reader, tablet computer, or tablet PC.

84. The non-transitory computer readable medium of claim 83, wherein the electronic device comprises a tablet computer.

85. The non-transitory computer readable medium of claim 16, wherein the electronic device comprises a handheld electronic device.

86. The non-transitory computer readable medium of claim 16, wherein the computer system comprises one or more visual, audible, or tactile features for communicating with the first participant or the second participant.

97. The non-transitory computer readable medium of claim 16, wherein the first participant and the second participant are the same person.

98. The non-transitory computer readable medium of claim 16, wherein the first participant and the second participant are different people.

17. A system for enhancing function of an electronic device in a clinical trial, the system comprising:

one or more computer processors; and

computer readable instructions for;

a. receiving, by the electronic device, first clinical trial data associated with a first participant in a first clinical trial;

b. communicating, by the electronic device, first data to one or more servers over a network, the first data comprising the first clinical trial data, first compliance data associated with the first clinical trial data, first subject identification information identifying the first participant, or first study identification information identifying the first clinical trial;

c. receiving, by the electronic device, second clinical trial data associated with a second participant in a second clinical trial;

d. communicating, by the electronic device, second data to the one or more servers over the network, the second data comprising the second clinical trial data, second compliance data associated with the second clinical trial data, second subject identification information identifying the second participant, or second study identification information identifying the second clinical trial;

e. generating and storing, by the one or more servers, a first data structure and a second data structure in a staging data repository, wherein the first data structure is based at least on the first data, and wherein the second data structure is based at least on the second data;

f. sifting, by the one or more servers, data structures from the staging data repository into a plurality of study data repositories, wherein the plurality of study data repositories comprises a first study data repository associated with the first clinical trial and a second study data repository associated with the second clinical trial and wherein the sifting comprises;

transferring, by the one or more servers, the first data structure to the first study data repository; and

transferring, by the one or more servers, the second data structure to the second study data repository;

g. locking, by the one or more servers, the first study data repository; and

h. preventing, by the one or more servers based at least on a determination that the first study data repository is locked, a third data structure from being transferred to the first study data repository; and

transferring, by the one or more servers, a fourth data structure to the second study data repository.

32. The system of claim 17, further comprising computer readable instructions for recording the first clinical trial data and the second clinical trial data on the electronic device.

33. The system of claim 17, wherein the electronic device is connected to the Internet.

34. The system of claim 17, further comprising computer readable instructions for accepting the first clinical trial data into the electronic device, and accepting the second clinical trial data into the electronic device.

35. The system of claim 17, further comprising computer readable instructions for accepting from a first individual the first clinical trial data into the electronic device, and accepting from a second individual the second clinical trial data into the electronic device.

36. The system of claim 17, further comprising computer readable instructions for accepting data from at least 3 clinical trials into the electronic device.

37. The system of claim 17, wherein the electronic device is in electronic communication with the staging data repository.

38. The system of claim 17, further comprising computer readable instructions for receiving, by the one or more servers, third data from the electronic device over the network, the third data comprising third clinical trial data associated with the first participant in the first clinical trial, third compliance data associated with the third clinical trial data, the first subject identification information, or the first study identification information.

39. The system of claim 37, further comprising computer readable instructions for receiving, by the one or more servers, fourth data from the electronic device over the network, the fourth data comprising fourth clinical trial data associated with the second participant, fourth compliance data associated with the fourth clinical trial data, the second subject identification information, or the second study identification information.

40. The system of claim 37, wherein the staging data repository is in electronic communication with the plurality of study data repositories.

41. The system of claim 38, further comprising computer readable instructions for storing, by the one or more servers, a third data structure in the staging data repository, wherein the third data structure is based at least on the third data.

42. The system of claim 39, further comprising computer readable instructions for storing, by the one or more servers, a fourth data structure in the staging data repository, wherein the fourth data structure is based at least on the fourth data.

43. The system of claim 40, further comprising computer readable instructions for adding a new study data repository to the plurality of study data repositories, wherein the new study data repository is in electronic communication with the staging data repository.

44. The system of claim 40, wherein the plurality of study data repositories comprise at least 2 study data repositories.

66. The system of claim 17, further comprising computer readable instructions for assessing validity of the first data or the second data.

67. The system of claim 66, further comprising computer readable instructions for performing an action based on the validity of the first data or the second data.

68. The system of claim 67, wherein the action comprises providing a message to the first participant, the second participant, a clinical trial staff, or a sponsor.

69. The system of claim 68, wherein the message is feedback.

70. The system of claim 67, wherein the action comprises excluding the first data or excluding the second data.

87. The system of claim 17, wherein the electronic device comprises a personal computer, minicomputer, mainframe, multiprocessor system, network computer, processor-based electronic device, desktop computer, laptop computer, PC computer, Macintosh computer, notebook computer, netbook computer, e-reader, tablet computer, or tablet PC.

88. The system of claim 87, wherein the electronic device comprises a tablet computer.

89. The system of claim 17, wherein the electronic device comprises a handheld electronic device.

90. The system of claim 17, wherein the electronic device comprises one or more visual, audible, or tactile features for communicating with the first participant or the second participant.

99. The system of claim 17, wherein the first participant and the second participant are the same person.

100. The system of claim 17, wherein the first participant and the second participant are different people.

18. A system for enhancing function of an electronic device in a clinical trial wherein data are from a plurality of participants, the system comprising:

a. the electronic device wherein the electronic device comprises;

i. a non-transitory computer readable medium comprising instructions, when executed by the electronic device, cause the electronic device to perform receiving first clinical trial data associated with a first participant in a first clinical trial and communicating, by the electronic device, first data to one or more servers over a network, the first data comprising the first clinical trial data, first compliance data associated with the first clinical trial data, first subject identification information identifying the first participant, or first study identification information identifying the first clinical trial,

ii. computer readable instructions, which when executed by the electronic device, cause the electronic device to perform receiving second clinical trial data associated with a second participant in a second clinical trial, and communicating, by the electronic device, second data to the one or more servers over the network, the second data comprising the second clinical trial data, second compliance data associated with the second clinical trial data, second subject identification information identifying the second participant, or second study identification information identifying the second clinical trial;

b. a staging data repository comprising;

i. a first data structure and a second data structure, wherein the first data structure is based at least on the first data, and wherein the second data structure is based at least on the second data; and

c. a plurality of study data repositories, where the plurality of study data repositories comprises;

i. a first study data repository associated with the first clinical trial and a second study data repository associated with the second clinical trial, wherein the first study data repository is locked.

45. The system of claim 18, further comprising computer readable instructions, when executed by the electronic device, cause the electronic device to perform recording the first clinical trial data and the second clinical trial data on the electronic device.

46. The system of claim 18, wherein the electronic device is connected to the Internet.

47. The system of claim 18, further comprising computer readable instructions, when executed by the electronic device, cause the electronic device to perform receiving from the first participant the first clinical trial data into the electronic device, and receiving from the second participant the second clinical trial data into the electronic device.

48. The system of claim 18, further comprising computer readable instructions, when executed by the electronic device, cause the electronic device to perform receiving from a first individual the first clinical trial data into the electronic device, and receiving from a second individual the second clinical trial data into the electronic device.

49. The system of claim 18, further comprising computer readable instructions, when executed by the electronic device, cause the electronic device to perform receiving data from at least 3 clinical trials into the electronic device.

50. The system of claim 18, wherein the electronic device is in electronic communication with the staging data repository.

51. The system of claim 18, further comprising computer readable instructions, when executed by the electronic device, cause the electronic device to perform receiving, by the one or more servers, third data from the electronic device over the network, the third data comprising third clinical trial data associated with the first participant in the first clinical trial, third compliance data associated with the third clinical trial data, the first subject identification information, or the first study identification information.

52. The systems of claim 18, further comprising computer readable instructions, when executed by the electronic device, cause the electronic device to perform receiving, by the one or more servers, fourth data from the electronic device over the network, the fourth data comprising fourth clinical trial data associated with the second participant, fourth compliance data associated with the fourth clinical trial data, the second subject identification information, or the second study identification information.

53. The system of claim 50, wherein the staging data repository is in electronic communication with the plurality of study data repositories.

54. The system of claim 53, further comprising computer readable instructions, which when executed by the plurality of study data repositories, cause the plurality of study data repositories to perform adding a new study data repository to the plurality of study data repositories, wherein the new study data repository is in electronic communication with the staging data repository.

55. The system of claim 53, wherein the plurality of study data repositories comprise at least 2 study data repositories.

71. The system of claim 18, further comprising computer readable instructions for performing an action based on the participant compliance.

72. The system of claim 71, wherein the action comprises providing a message to the first participant, the second participant, a clinical trial staff, or a sponsor.

73. The system of claim 71, wherein the action comprises excluding the first data or excluding the second data.

74. The system of claim 18, further comprising computer readable instructions for assessing validity of the first data or the second data.

75. The system of claim 74, further comprising computer readable instructions for performing an action based on the validity of the first data or the second data.

76. The system of claim 75, wherein the action comprises providing a message to the first participant, the second participant, a clinical trial staff, or a sponsor.

77. The system of claim 76, wherein the message is feedback.

78. The system of claim 75, wherein the action comprises excluding the first data or excluding the second data.

91. The system of claim 18, wherein the electronic device comprises a personal computer, minicomputer, mainframe, multiprocessor system, network computer, processor-based electronic device, desktop computer, laptop computer, PC computer, Macintosh computer, notebook computer, netbook computer, e-reader, tablet computer, or tablet PC.

92. The system of claim 91, wherein the electronic device comprises a tablet computer.

93. The system of claim 18, the electronic device comprises a handheld electronic device.

94. The system of claim 18, wherein the electronic device comprises one or more visual, audible, or tactile features for communicating with the first participant or the second participant.

101. The system of claim 18, wherein the first participant and the second participant are the same person.

102. The system of claim 18, wherein the first participant and the second participant are different people.