Method and apparatus of assuring informed consent while conducting secure clinical trials

• US 20040006553A1
• Filed: 05/09/2003
• Published: 01/08/2004
• Est. Priority Date: 11/10/2000
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Inventors: de Vries, Glen M., Ikeguchi, Edward F., Te, Alexis E.
• Granted Patent: US 7,596,541 B2
• Time in Patent Office: Days
• US Class Current: 707/1
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
• CPC Class Codes: Y10S 707/99931 Database or file accessing

Abstract

The present invention is a method for conducting clinical trials. The clinical trial consists of the inventive system (10); a computing device (12); application database (11a), the personnel database (11b), and the trial data database; computing devices (14a), (14b), and (14c) for use by trial participants and trial investigators; computing device (15); computer devices (16a), (16b), and (16c) for use by trial monitors; computing devices (18a), (18b), and (18c) for use by laboratories to connect via the network (20).

Claims

1. A method of assuring an informed consent of one or more trial participants, the informed consent signifying an understanding of aspects of a test of a plurality of tests and an agreement to participate in performance of the test, the plurality of tests is carried out during a conduct of a clinical trial by a plurality of members, the plurality of members including the one or more trial participants the clinical trial being conducted on at least one trial computing device connected to a network via one or more data paths, said method comprising the steps of:

conducting the clinical trial according to established procedural guidelines whereby the one or more trial participants perform the plurality of tests by

providing the informed consent when required,

performing the test;

providing test data to the at least one trial computing device.

2. The method of claim 1, further comprising the steps of:

establishing the clinical trial by scheduling one or more periods of execution for accepting said test data;

assigning the plurality of tests to be performed during said one or more periods;

defining a plurality of elements for each of said plurality of tests; and

identifying a plurality of exceptions for setting limits on said test data.

3. The method of claim 2, further comprising the step of establishing procedural guidelines for conducting the clinical trial, said guidelines identifying which of the plurality of tests require the one or more trial participants to provide the informed consent.

4. The method of claim 3, further comprising the step of identifying at least one trial administrator and the one or more trial participants for the conduct of the clinical trial.

5. The method of claim 4, further comprising the steps of:

detecting discrepancies in said provided test data; and

requesting the one or more trial participants who provided said test data in which discrepancy was detected to provide the informed consent.

6. The method of claim 5, further comprising the step of preventing the one or more trial participants from further participation in the clinical trial if the informed consent was not provided.

7. The method of claim 6, further comprising the steps of:

alerting the one or more trial participants to perform the test scheduled to be performed during a particular period of execution; and

continuously attempting to reach the one or more trial participants if the one or more trial participants fail to reply.

8. The method of claim 7, wherein the step of alerting further comprising the step of contacting the participant'"'"'s computing device by sending a message at a network address of the device and displaying a recorded alerting message when the participant reads the message.

9. The method of claim 7, wherein the step of alerting further comprising the step of contacting the participant'"'"'s computing device by dialing a telephone number of the device if the participant'"'"'s computing device is a telephone and playing a recorded alerting message when the participant answers.

10. The method of claim 7, wherein the step of alerting further comprising the step of contacting the one or more trial participants'"'"' pager by dialing a telephone number of the pager and sending a call back number to the pager and playing a recorded alerting message when the participant calls the call back number.

11. A method of assuring informed consent while electronically conducting a clinical trial, the clinical trial having a plurality of members, the plurality of members including at least one trial administrator, at least one trial monitor, at least one trial investigator, and one or more trial participants, the plurality of members using one or more computing devices connected to a network to perform a plurality of transactions of the clinical trial, said method comprising the steps of:

(a) establishing procedural guidelines for the clinical trial;

(b) performing the clinical trial according to the procedural guidelines by carrying out a plurality of tests;

(c) detecting a discrepancy in said plurality of tests; and

(d) requesting an informed consent if said discrepancy is found.

12. The method of claim 11, further comprising the steps of:

(e) the at least one trial administrator selecting the at least one trial monitor and the at least one trial investigator;

(f) the at least one trial investigator selecting the one or more trial participants to be enrolled in the one or more clinical trial; and

(g) the at lest one trial monitor observing the one or more clinical trial to detect any deviations from the procedural guidelines.

13. The method of claim 12, further comprising the steps of authenticating said plurality of members and accepting only these of the plurality of transactions that are performed by said plurality of members that are authenticated.

14. The method of claim 11, wherein the plurality of members comprises at least one trial administrator, at least one trial monitor, at least one trial investigator, and one or more trial participants, the at least one trial administrator selecting the at least one trial monitor and the at least one trial investigator, the at least one trial investigator selecting the one or more trial participants to be enrolled in the one or more clinical trial, the at lest one trial monitor observing the one or more clinical trial to detect any deviations from the procedural guidelines.

15. The method of claim 14, wherein the plurality of members further comprises:

one or more reporters;

one or more scientists, and one or more publishers.

16. The method of claim 15, wherein the at least one trial administrator selects said at least one trial investigator according to an open enrollment, in said open enrollment anyone qualified to act as a trial investigator is permitted to register as the at least one trial investigator.

17. The method of claim 16, wherein the at lest one trial administrator selects said at least one trial investigator according to a by-invitation-only enrollment, in said by invitation only enrollment the at least one trial administrator registers said at least one trial investigator.

18. The method of claim 17, wherein each said one or more clinical trial comprises:

an identification of the at least one trial administrator, and an identification of the one or more trial participants to be enrolled in the clinical trial;

a schedule of a one or more periods of execution during which period a one or more test values are accepted;

a plurality of tests for each of said one or more periods on said schedule;

a plurality of elements for each of said plurality of tests; and

a plurality of exceptions for setting limits on said one or more test values.

19. The method of claim 18, wherein each of the plurality of members has an associated set of pre-established permission standards, said permission standards define a level of access by each of the plurality of members to said one or more test values.

20. The method of claim 19, further including a step of allowing access by the at least one trial investigator to said one or more test values through a use of said identification of the one or more trial participants.

21. The method of claim 20, further including a step of allowing access by the at least one trial monitor to said one or more test values through a use of said identification of the one or more trial participants.

22. The method of claim 21, wherein said carrying out of the plurality of transactions comprises the following steps:

determining a level of access allowed and a level of authentication necessary for a one or more of the plurality of members performing the plurality of transactions;

performing an authentication method corresponding to said determined level of authentication, each of the plurality of transactions comprises steps performed by said one or more of the plurality of members after said performance of said authentication method;

exhibiting said plurality of tests and said plurality of elements and permitting entry of a one or more test values in satisfaction of said exhibited plurality of elements; and

accepting said one or more test values and determining if said accepted one or more test values are outside of said limits.

23. The method of claim 22, wherein said authentication uses biometrics and non biometrics methods.

24. The method of claim 23, wherein if said authentication method fails said plurality of transactions is not permanently stored.

25. The method of claim 24, wherein if said authentication method fails said plurality of transactions is marked as failed and is permanently stored.

26. The method of claim 25, wherein said authentication method starts the clock running on a time range within which the plurality of transactions must be carried out.

27. The method of claim 26, wherein the plurality of transactions is prevented from being carried out if said time range is exceeded, said time range is specified by said at lest one trial administrator for each of said plurality of members.

28. The method of claim 27, wherein said plurality of elements are dynamically generated for said one or more periods of execution, whereby only these of said plurality of elements that require said one or more test values to be entered are exhibited.

29. The method of claim 28, further comprising steps of exhibiting a confirmation dialog to insure that said entered one or more test values determined to be outside of said limits are correct, and if not correct then insuring that said entered one or more test values be corrected.

30. The method of claim 29, wherein said entered one or more test values comprise:

a unique key for identifying a transaction;

a trial key for identifying the clinical trial;

a test key for identifying said first test of said plurality of tests of the clinical trial identified by said trial key;

an intervals key for identifying each of said one or more periods of execution of said first test;

an element key for identifying each of said plurality of elements;

an identification key for identifying said at least one trial investigator and said at least one trial participant who entered said information value;

a patient identification key for identifying each said at least one trial participant;

a date and time created field for storing temporal values of recording of said information value;

a data certification code field comprising a plurality of random digits;

a unique identifier field to identify the computing devices; and

an authentication field for identifying said authentication method performed.

31. The method of claim 30, further comprising a step of producing a plurality of reports of the plurality of transactions, said plurality of reports are created from said one or more test values and retrieved according to one or more keys comprising:

a date and time of each of said plurality of transactions;

a network address of the computing devices from which information was entered;

an identification of the at least one trial investigator;

an identification of the computing device on which said plurality of transactions was entered; and

a unique encryption stamp for each of said plurality of transactions.

32. The method of claim 31, wherein said step of producing said plurality of reports enables finding said discrepancy and thereby verify veracity of the one or more clinical trial.

33. The method of claim 32, wherein said step of producing said plurality of reports enables evaluation of performance of the at least one trial investigator.

34. The method of claim 33, wherein the network is Internet.

35. The method of claim 33, wherein the network is a telecommunications network.

36. A method of authenticating performance of a test and entry of test data during execution of a clinical trial to guaranty that the test occurred according to procedural guidelines, included informed consent, and was performed by an authorized participant, the test being performed and the test data is entered by a plurality of authorized participants using a plurality of participant'"'"'s computing devices into at least one trial computing device executing a trial management program, the at least one trial computing device and the plurality of participant'"'"'s computing devices are connected to a network, said method comprising the steps of:

a) establishing the clinical trial by scheduling one or more periods of execution for accepting said test data, assigning the plurality of tests to be performed during said one or more periods, defining a plurality of elements for each of said plurality of tests, and identifying a plurality of exceptions for setting limits on said test data;

b) establishing procedural guidelines for conducting the clinical trial, said guidelines identifying which of the plurality of tests require the one or more trial participants to provide the informed consent; and

c) conducting the clinical trial according to established procedural guidelines whereby the one or more trial participants perform the plurality of tests by providing the informed consent when required, performing the test, and providing the test data to the at least one trial computing device.

37. The method of claim 36, further comprising the step of assuring authenticity of the informed consent by providing an electronic signature, the electronic signature including a public token and a private token.

38. The method of claim 37, further comprising the steps of:

examining the test data to detect discrepancies, sufficiency of the informed consent or in the electronic signatures used to guarantee the informed consent;

requesting a new informed consent to be provided by the authorized participant who provided the test data in which discrepancy was detected; and

notifying an administrator in a position to prevent fraud and to determine and prevent danger to the authorized participant.

39. A method of authentication of the conduct, recordation, and a plurality of members of one or more clinical trials, the plurality of members including at least one trial administrator, at least one trial monitor, at least one trial investigator, and one or more trial participants, the at least one trial administrator selecting the at least one trial monitor and the at least one trial investigator and defining procedural guidelines for the one or more clinical trials, the at least one trial investigator selecting the one or more trial participants to be enrolled in the one or more clinical trials, the at lest one trial monitor observing the one or more clinical trials to detect any deviations from the procedural guidelines, the plurality of members using one or more member computing devices connected to at least one trial computing device via a network to perform a plurality of transactions of the one or more clinical trials, the method comprising the steps of:

a) establishing a plurality of tests and procedural guidelines for each of the one or more clinical trials, each of said plurality of tests comprising a one or more periods of execution, a plurality of elements, and a plurality of exception limits;

b) providing to each of the plurality of members a level of access to the test data and an electronic signature, the electronic signature including a public token and a private token;

c) performing the one or more clinical trials according to the procedural guidelines and accepting the test data of the one or more clinical trials including informed consent forms, the informed consent forms being signed by the one or more trial participants using electronic signature; and

d) assuring veracity of the one or more clinical trials and notifying the at least one trial administrator if discrepancy is found in the trial data, the informed consent, or in the electronic signatures used to guarantee the informed consent, the at least one trial administrator being in a position to prevent fraud.

40. The method of claim 39, wherein the step of providing the electronic signature further comprising the steps of:

accepting a public token selected by a member;

generating, storing, and providing to the member a secret token;

accepting said public token and said secret token from said member and confirming trustfulness of said member by confirming previously stored identity information of said member; and

said member selecting a new secret token after providing said public token and said secret token.

41. A method of authenticating performance and recordation of a transaction during execution of a clinical trial to guaranty that the transaction occurred in a proscribed manner and was performed by authorized personnel members, the transaction being performed by the authorized personnel members from a plurality of computing devices connected to a network by using data entry programs, the transaction being recorded on an at least one computing device executing a trial management program, said method comprising the steps of:

a) establishing in the clinical trial a schedule of a plurality periods of execution during which period a plurality of test values are accepted;

a plurality of tests for each of said plurality of periods, a plurality of elements for each of said plurality of tests, and a plurality of exceptions for setting limits on said one or more test values;

b) the authorized personnel members accessing the at least one computing device executing the trial management program and identifying themselves;

c) determining a level of access allowed and a level of authentication necessary for the authorized personnel members;

d) presenting said plurality of tests and said plurality of elements and initiating a timer on a time range within which the transaction must be completed;

e) accepting a plurality of test values in satisfaction of said plurality of elements; and

f) recording said plurality of test values of the transaction if the transaction was completed with in said time range.

42. The method of claim 41, wherein said authentication uses biometrics and non biometrics methods.

43. The method of claim 42, further comprising a step of determining if said accepted plurality of test values are outside of said limits.

44. The method of claim 43, further comprising steps of exhibiting a confirmation dialog to insure that said plurality of test values determined to be outside of said limits are correct, and if not correct then accepting a new plurality of test values.

45. A method of authenticating the execution and recordation of at least one clinical trial, said method comprising the steps of:

a) constructing a first database with

a set of first records defining the at least one clinical trial to be executed,

a set of second records defining dates on which tests of the at least one clinical trial will be executed,

a set of third records defining respectively said tests executed corresponding to said dates, and

a set of fourth records defining respectively elements of said tests, said elements are parameters to be tested by the corresponding tests,

b) constructing a second database to list only those trial participants that are permitted to enter and access data of the at least one clinical trial;

c) requesting permission to enter trial data by providing identifying information of said trial participant who will enter said trial data and on whose behalf said data is being entered and comparing said identifying information with the list of said trial participants in said second database and authenticating and permitting entry of said trial data if there is a match;

d) accepting said trial data from said authenticated trial participant, said trial data comprising timing information of duration of entry of said trial data and the parameters to which the trial data relates; and

e) testing said accepted trial data by comparing said timing information of duration of entry and the parameters with those timing information of duration and parameters in the first database and, if there is a match, accepting said trial data.

46. The method of claim 45, wherein said first database is further constructed with a set of fifth records defining value ranges of said elements, and testing whether the trial data related to the parameters falls within said value ranges.

47. The method of claim 46, wherein said accepted trial data is stored in a third database.

48. A method of authentication of the conduct and recordation of one or more clinical trials, the one or more clinical trials having a plurality of members including at least one trial administrator, at least one trial monitor, at least one trial investigator, and one or more trial participants, the at least one trial administrator selecting the at least one trial monitor and the at least one trial investigator and defining procedural guidelines for the one or more clinical trials, the at least one trial investigator selecting the one or more trial participants to be enrolled in the one or more clinical trials, the at lest one trial monitor observing the one or more clinical trials to detect any deviations from the procedural guidelines, the plurality of members using one or more computing devices connected to a network to perform a plurality of transactions of the one or more clinical trials, the plurality of transactions being stored in a third database, the method comprising the steps of:

a) establishing in a first database a plurality of tests and procedural guidelines for each of the one or more clinical trials, each of said plurality of tests comprising a one or more periods of execution, a plurality of elements, and a plurality of exception limits and defining in a second database the plurality of members;

b) recruiting and registering the plurality of members in said second database, each of the plurality of members being assigned level of access to a third database;

c) performing the one or more clinical trials according to the procedural guidelines by carrying out all of the plurality of transactions making up the one or more clinical trials; and

d) querying said third database at random to assure veracity of the one or more clinical trials and notifying the at least one trial administrator if discrepancy is found, the at least one trial administrator being in a position to prevent fraud.

49. A method of authenticating performance of a transaction during execution of a clinical trial to guaranty that the transaction occurred in a proscribed manner, the transaction being entered through a data entry program executing on a first at least one computing device into a third database managed by a trial management program executing on a second at least one computing device, said first at least one computing device and said second at least one computing device are connected to a network, said method comprising the steps of:

a) establishing in a first database progression of transactions of the clinical trial comprising a schedule of a plurality of periods of execution during which period a plurality of test values are accepted;

a plurality of tests for each of said plurality of periods, a plurality of elements for each of said plurality of tests, and a plurality of exceptions for setting limits on said one or more test values;

b) establishing in a second database a list of a plurality of trial members enrolled to perform said progression of transactions;

c) said trial members performing said progression of transactions by executing the data entry program, the trial management program identifying said trial members and determining a level of access allowed and performing a level of authentication necessary;

d) displaying said plurality of elements and accepting a plurality of test values in satisfaction of said plurality of elements; and

f) recording said plurality of test values if said plurality of test values was received with in a time range within which the transaction must be completed.