Automatic self-documentation in a mobile-native clinical trial operations system and service suite

1. A system, comprising:

one or more computational elements; and

a non-transitory storage medium including instructions executable by the one or more computational elements to configure the one or more computational elements to:

provide a coordinator-customized patient application configured to access a patient portal generated using a trial design services module, for providing patient information for a clinical trial;

iterate over a representation of workflows and logic for each application, portal service, relay service, gateway, and analytics module of the coordinator-customized patient application, traversal paths through each workflow, based on decision points in the workflow and a range of possible inputs that may be provided by a user at each decision point of the decision points;

in response to iterating traversal paths over workflows in the representation of workflows, iterate a simulated path over resulting traversal paths applying to each workflow; and

insert into an institutional review board document, a representation of any traversal path that includes user screens and corresponding user inputs as determined by the simulated path.

2. The system of claim 1 , wherein the instructions are executable by the one or more computational elements to selectively generate an entire specification document describing a design of an entire clinical trial operations system.

3. The system of claim 1 , wherein the trial design services module comprises an application factory system that automatically generates via a workflow palette and a composition studio's visual programming toolkit, the user screens for the clinical trial.

4. The system of claim 3 , wherein the application factory system comprises:

an automatic verification framework with a test case result recorder, configured to capture in a specification document, associated inputs, state changes, outputs, and result status for test cases;

a test plan database including coverage tests with cases targeted at executing at least some of the logic in an object to be verified and a plurality of document templates, containing standard formats for documents that are generated automatically;

an interactive verification framework with a document editor and supporting user interface;

a test device library containing testable device models;

application objects and application components to be verified; and

a verification service which verifies the application objects and application components.

5. The system of claim 4 , further comprising, a build engine with compilation and subsystem linking services.

6. The system of claim 5 , wherein the build engine uses a test coverage generator as a compiler.

7. The system of claim 4 , further comprising, a composition studio providing an ability to develop applications and the application components.

8. The system of claim 7 , further comprising, a document creation request control.

9. The system of claim 7 , wherein the composition studio utilizes a multimedia user interface design toolkit and programming design toolkit.

10. A non-transitory storage medium including instructions executable by one or more computational elements to perform operations comprising:

providing a coordinator-customized patient application configured to access a patient portal generated using a trial design services module, for providing patient information for a clinical trial ;

iterating over a representation of workflows and logic for each application, portal service, relay service, gateway, and analytics module of the coordinator-customized patient application, traversal paths through each workflow, based on decision points in the workflow and a range of possible inputs that may be provided by a user at each decision point of the decision points;

in response to iterating traversal paths over workflows in the representation of workflows, iterating a simulated path over resulting traversal paths applying to each workflow; and

inserting into an institutional review board document, a representation of any traversal path that includes user screens and corresponding user inputs as determined by the simulated path.

11. The non-transitory storage medium of claim 10 , wherein the operations further comprise selectively generating an entire specification document describing a design of an entire trial.

12. The non-transitory storage medium of claim 10 , wherein the operations further comprise generating, using a workflow palette and a composition studio's visual programming toolkit, the user screens for the clinical trial.

13. The non-transitory storage medium of claim 12 , wherein the operations further comprise:

capturing in a specification document, associated inputs, state changes, outputs, and result status for test cases;

executing at least some of the logic in an object to be verified;

accessing an interactive verification framework with a document editor and supporting user interface to edit the specification document;

using a test device library containing testable device models to test at least one device model;

verifying application objects and application components; and

verifying the application objects and application components.

14. The non-transitory storage medium of claim 13 , wherein the operations further comprise, providing compilation and subsystem linking services using a build engine.

15. The non-transitory storage medium of claim 14 , wherein the build engine uses a test coverage generator as a compiler.

16. The non-transitory storage medium of claim 13 , wherein the operations further comprise, providing a composition studio configured to provide an ability to develop applications and the application components.

17. The non-transitory storage medium of claim 16 , wherein the operations further comprise, providing a document creation request control.

18. The non-transitory storage medium of claim 16 , wherein the composition studio utilizes a multimedia user interface design toolkit and programming design toolkit.