Granted Patent B2

US 12,525,325 · App. 18/489,721 · Granted Jan 13, 2026

Inventors: Jeff Beeler (Cary, NC); Matt Sabol (Springfield, VA); John Bigley (Lincoln, CA)

G16H10/20

Abstract

Claims (47)

1 . A method for using data reference links to maintain data validation, comprising:

storing, in a centralized electronic Clinical Outcome Assessment (eCOA) library, a set of validated instruments, each validated instrument being defined by a data structure that is validated for clinical use such that a respective validation is bound to the data structure and is untransferable to any copies or reproductions of the data structure;

initiating, via a trial server, a trial session for a user;

determining, via the trial server, a validated instrument of the set of validated instruments to be accessed from the eCOA library for the trial session;

transmitting, to the eCOA library and via the trial session, a request for an instance of the validated instrument;

receiving, from the eCOA library, a data reference object that is operable as a data reference link to the validated instrument stored in the eCOA library, such that the data reference object is operable to execute the validated instrument without generating a copy or reproduction of the validated instrument; and

causing a Graphical User Interface (GUI) of the trial session to operate the data reference object, such that a user device executes the validated instrument by reference to the validated instrument centrally stored in the eCOA library without generating a copy or reproduction of the validated instrument and while maintaining the validation bound to the validated instrument stored in the eCOA library.

2 . The method of claim 1 , wherein the validated instrument is an electronic questionnaire.

3 . The method of claim 1 , wherein initiating the trial session includes associating the user with a study, wherein the validated instrument is associated with the study.

4 . The method of claim 3 , wherein the validated instrument is further associated with at least one further study, such that the data reference object is operable in parallel with operation of one or more other data reference objects linked to the validated instrument for the at least one further study.

5 . The method of claim 1 , wherein the eCOA library is configured to store the validated instrument in a fast healthcare interoperability resource server associated with the eCOA library.

6 . The method of claim 5 , further comprising:

accessing, the trial server via an authorization system, the authorization system including (i) an identity provider web service configured to access the fast healthcare interoperability resource server, and (ii) a firewall.

7 . The method of claim 1 , wherein the user device executing the validated instrument by reference accesses a validated screenshot of the validated instrument, allowing for the user to insert answers into the validated screenshot.

8 . The method of claim 1 , wherein the request to the eCOA library includes a request for at least one further validated instrument, such that at least one further data reference object corresponding to the at least one further validated instrument is received from the eCOA library, and such that the GUI is caused to operate the at least one further data reference object such that the user device executes the at least one further validated instrument by reference.

9 . The method of claim 1 , further comprising:

saving the executed validated instrument by reference to one or more storage devices.

10 . The method of claim 1 , further comprising:

compiling the executed validated instrument and associating at least one user response included with the executed validated instrument with a study.

11 . A system, the system comprising:

a centralized electronic Clinical Outcome Assessment (eCOA) library storing a set of validated instrument, each validated instrument being defined by a data structure that is validated for clinical use such that a respective validation is bound to the data structure and is untransferable to any copies or reproductions of the data structure;

a user device associated with a user; and

a trial server, including:

at least one memory storing instructions; and

at least one processor configured to execute the instructions to perform operations for determining data integrity, the operations including:

causing the user device to initiate a trial session for the user;

determining a validated instrument of the set of validated instruments to be accessed from the eCOA library for the trial session;

transmitting, to the eCOA library and via the trial session, a request for an instance of the validated instrument;

receiving, from the eCOA library, a data reference object that is operable as a data reference link to the validated instrument stored in the eCOA library, such that the data reference object is operable to execute the validated instrument without generating a copy or reproduction of the validated instrument; and

causing a Graphical User Interface (GUI) of the trial session to operate the data reference object, such that a user device executes the validated instrument by reference to the validated instrument centrally stored in the eCOA library without generating a copy or reproduction of the validated instrument and while maintaining the validation bound to the validated instrument stored in the eCOA library.

12 . The system of claim 11 , wherein the validated instrument is an electronic questionnaire.

13 . The system of claim 11 , wherein initiating the trial session includes associating the user with a study, wherein the validated instrument is associated with the study.

14 . The system of claim 13 , wherein the validated instrument is further associated with at least one further study, such that the data reference object is operable in parallel with operation of one or more other data reference objects linked to the validated instrument for the at least one further study.

15 . The system of claim 11 , wherein the eCOA library is configured to store the validated instrument in a fast healthcare interoperability resource server associated with the eCOA library.

16 . The system of claim 15 , further comprising:

an authorization system including (i) an identity provider web service configured to access the fast healthcare interoperability resource server, and (ii) a firewall, wherein the authorization system is configured to control access to the trial server.

17 . The system of claim 11 , wherein the user device executing the validated instrument by reference via the trial session accesses a validated screenshot of the validated instrument, and is configured to enable the user to insert answers into the validated screenshot.

18 . The system of claim 11 , wherein the request to the eCOA library includes a request for at least one further validated instrument, such that at least one further data reference object corresponding to the at least one further validated instrument is received from the eCOA library, and such that the GUI is caused to operate the at least one further data reference object such that the user device executes the at least one further validated instrument by reference.

19 . The system of claim 11 , further comprising:

saving the executed validated instrument by reference to one or more storage devices.

20 . A non-transitory computer readable medium storing processor-readable instructions which, when executed by at least one processor, cause the at least one processor to perform operations including:

storing, in a centralized electronic Clinical Outcome Assessment (eCOA) library, a set of validated instrument, each validated instrument being defined by a data structure that is validated for clinical use such that a respective validation is bound to the data structure and is untransferable to any copies or reproductions of the data structure;

initiating, via a trial server, a trial session for a user;

determining, via the trial server, a validated instrument form the set of validated instruments to be accessed from the eCOA library for the trial session;

transmitting, to the eCOA library and via the trial session, a request for an instance of the validated instrument;

receiving, from the eCOA library, a data reference object that is operable as a data reference link to the validated instrument stored in the eCOA library, such that the data reference object is operable to execute the validated instrument without generating a copy or reproduction of the validated instrument; and

causing a Graphical User Interface (GUI) of the trial session to operate the data reference object, such that a user device executes the validated instrument by reference to the validated instrument centrally stored in the eCOA library without generating a copy or reproduction of the validated instrument and while maintaining the validation bound to the validated instrument stored in the eCOA library.

Assignments (5)

Continuity (1)

References Cited (18)