SYSTEMS AND METHODS FOR REUSABLE VALIDATED INSTRUMENTS

1 . A method for reusing validated instruments across multiple clinical studies, comprising:

storing, in an instrument library, a validated instrument that has undergone clinical validation for a first clinical study;

receiving, at the instrument library, a first request from a first trial server associated with the first clinical study for access to the validated instrument;

providing, to the first trial server, a first data reference object that operates as a first data reference link to the validated instrument stored in the instrument library without generating a copy of the validated instrument and while maintaining the clinical validation;

receiving, at the instrument library, a second request from a second trial server associated with a second clinical study for access to the validated instrument; and

providing, to the second trial server, a second data reference object that operates as a second data reference link to the validated instrument stored in the instrument library, such that the validated instrument is reused in the second clinical study without generating a copy of the validated instrument, while maintaining the clinical validation, and without requiring revalidation.

2 . The method of claim 1 , wherein the validated instrument includes an electronic clinical outcome assessment.

3 . The method of claim 1 , wherein the first clinical study and the second clinical study are conducted by different sponsors.

4 . The method of claim 1 , wherein the validated instrument is stored in a fast healthcare interoperability resource server associated with the instrument library.

5 . The method of claim 1 , further comprising:

causing a first graphical user interface (GUI) of a first trial session associated with the first clinical study to operate the first data reference object, such that a first user device executes the validated instrument by reference for the first clinical study without generating a copy of the validated instrument and while maintaining the clinical validation; and

causing a second GUI of a second trial session associated with the second clinical study to operate the second data reference object, such that a second user device executes the validated instrument by reference for the second clinical study without generating a copy of the validated instrument and while maintaining the clinical validation.

6 . The method of claim 1 , wherein the first data reference object and the second data reference object are operable in parallel.

7 . The method of claim 1 , wherein the validated instrument is accessed and executed by a user via a user device, and the validated instrument is operable to receive one or more answers inserted by the user.

8 . The method of claim 1 , further comprising:

receiving, at the instrument library, a third request from a third trial server associated with a third clinical study for access to the validated instrument; and

providing, to the third trial server, a third data reference object that operates as a third data reference link to the validated instrument stored in the instrument library without generating a copy of the validated instrument and without requiring revalidation.

9 . The method of claim 1 , further comprising:

saving user responses to the validated instrument from the third clinical study to one or more storage devices.

10 . The method of claim 1 , further comprising:

compiling user responses to the validated instrument and associating the user responses with the first clinical study and the second clinical study respectively.

11 . A system for reusing validated instruments across multiple clinical studies, the system comprising:

at least one memory storing instructions; and

at least one processor configured to execute the instructions to perform operations including:

storing, in an instrument library, a validated instrument that has undergone clinical validation for a first clinical study;

receiving, at the instrument library, a first request from a first trial server associated with the first clinical study for access to the validated instrument;

providing, to the first trial server, a first data reference object that operates as a first data reference link to the validated instrument stored in the instrument library without generating a copy of the validated instrument and while maintaining the clinical validation;

receiving, at the instrument library, a second request from a second trial server associated with a second clinical study for access to the validated instrument; and

providing, to the second trial server, a second data reference object that operates as a second data reference link to the validated instrument stored in the instrument library, such that the validated instrument is reused in the second clinical study without generating a copy of the validated instrument, while maintaining the clinical validation, and without requiring revalidation.

12 . The system of claim 11 , wherein the validated instrument includes an electronic clinical outcome assessment.

13 . The system of claim 11 , wherein the first clinical study and the second clinical study are conducted by different sponsors.

14 . The system of claim 11 , wherein the validated instrument is stored in a fast healthcare interoperability resource server associated with the instrument library.

15 . The system of claim 11 , the operations further including:

causing a first GUI of a first trial session associated with the first clinical study to operate the first data reference object, such that a first user device executes the validated instrument by reference for the first clinical study without generating a copy of the validated instrument and while maintaining the clinical validation; and

causing a second GUI of a second trial session associated with the second clinical study to operate the second data reference object, such that a second user device executes the validated instrument by reference for the second clinical study without generating a copy of the validated instrument and while maintaining the clinical validation.

16 . The system of claim 11 , wherein the first data reference object and the second data reference object are operable in parallel.

17 . The system of claim 11 , wherein the validated instrument is accessed and executed by a user via a user device, and the validated instrument is operable to receive one or more answers inserted by the user.

18 . The system of claim 11 , the operations further including:

receiving, at the instrument library, a third request from a third trial server associated with a third clinical study for access to the validated instrument; and providing, to the third trial server, a third data reference object that operates as a third data reference link to the validated instrument stored in the instrument library without generating a copy of the validated instrument and without requiring revalidation.

19 . The system of claim 11 , the operations further including:

saving user responses to the validated instrument from the third clinical study 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 an instrument library, a validated instrument that has undergone clinical validation for a first clinical study;

receiving, at the instrument library, a first request from a first trial server associated with the first clinical study for access to the validated instrument;

providing, to the first trial server, a first data reference object that operates as a first data reference link to the validated instrument stored in the instrument library without generating a copy of the validated instrument and while maintaining the clinical validation;

receiving, at the instrument library, a second request from a second trial server associated with a second clinical study for access to the validated instrument; and

providing, to the second trial server, a second data reference object that operates as a second data reference link to the validated instrument stored in the instrument library, such that the validated instrument is reused in the second clinical study without generating a copy of the validated instrument, while maintaining the clinical validation, and without requiring revalidation.