Automatic Self-Documentation in a Mobile-Native Clinical Trial Operations System and Service Suite

Abstract

A self-documenting clinical trial operations system and service suite and method, with a clinical trial operation software, a coordinator application and coordinator portal, providing information for the clinical trial operation software, a trial design services module, examining a trial design provided by a coordinator and automatically generating a software specification for a trial operations service suite, a patient application and patient portal generated from the trial design services module, for providing patient information for the clinical trial operation software, a customization option to customize at least one of the patient application and patient portal, a specification option to generate a specification document describing a design of a coordinator-customized patient application, wherein the customization and specification options are provided to the coordinator via the coordinator portal.

1 - 22 . (canceled) 
     
     
         23 . A method comprising:
 providing a coordinator-customized patient application configured to access a patient portal for a clinical trial;   iterating over a representation of workflows of the coordinator-customized patient application, each workflow based on decision points and a range of possible inputs at each decision point of the decision points;   iterating, in response to iterating traversal paths over the representation of workflows, a simulated path over resulting traversal paths applying to each workflow; and   inserting into a review board document, a representation of any traversal path that includes user screens for the clinical trial and corresponding user inputs as determined by the simulated path.   
     
     
         24 . The method of  claim 23 , further comprising selectively generating a specification document describing a design of the clinical trial. 
     
     
         25 . The method of  claim 23 , further comprising generating, using a workflow palette and a visual programming toolkit, the user screens for the clinical trial. 
     
     
         26 . The method of  claim 25 , further comprising:
 capturing in a specification document, associated inputs, state changes, outputs, and result status for test cases;   executing at least some 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; and   verifying application objects and application components.   
     
     
         27 . The method of  claim 26 , further comprising providing compilation and subsystem linking services using a build engine. 
     
     
         28 . The method of  claim 26 , further comprising accessing a composition studio configured to produce applications and the application components. 
     
     
         29 . The method of  claim 28 , further comprising providing a document creation request control. 
     
     
         30 . 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 for a clinical trial; 
 iterate over a representation of workflows of the coordinator-customized patient application, each workflow based on decision points and a range of possible inputs at each decision point of the decision points; 
 iterate, in response to iterating traversal paths over the representation of workflows, a simulated path over resulting traversal paths applying to each workflow; and 
 insert into a review board document, a representation of any traversal path that includes user screens for the clinical trial and corresponding user inputs as determined by the simulated path. 
   
     
     
         31 . The system of  claim 30 , wherein the instructions are executable to configure the one or more computational elements to selectively generate a specification document describing a design of the clinical trial. 
     
     
         32 . The system of  claim 30 , wherein the instructions are executable to configure the one or more computational elements to generate, using a workflow palette and a visual programming toolkit, the user screens for the clinical trial. 
     
     
         33 . The system of  claim 32 , wherein the instructions are executable to configure the one or more computational elements to:
 capture in a specification document, associated inputs, state changes, outputs, and result status for test cases;   execute at least some logic in an object to be verified;   access an interactive verification framework with a document editor and supporting user interface to edit the specification document;   use a test device library containing testable device models to test at least one device model; and   verify application objects and application components.   
     
     
         34 . The system of  claim 33 , wherein the instructions are executable to configure the one or more computational elements to provide compilation and subsystem linking services using a build engine. 
     
     
         35 . The system of  claim 33 , wherein the instructions are executable to configure the one or more computational elements to access a composition studio configured to produce applications and the application components. 
     
     
         36 . The system of  claim 35 , wherein the instructions are executable to configure the one or more computational elements to provide a document creation request control. 
     
     
         37 . 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 for a clinical trial;   iterating over a representation of workflows of the coordinator-customized patient application, each workflow based on decision points and a range of possible inputs at each decision point of the decision points;   iterating, in response to iterating traversal paths over the representation of workflows, a simulated path over resulting traversal paths applying to each workflow; and   inserting into a review board document, a representation of any traversal path that includes user screens for the clinical trial and corresponding user inputs as determined by the simulated path.   
     
     
         38 . The non-transitory storage medium of  claim 37 , wherein the instructions are further executable to perform operations comprising generating a specification document describing a design of the clinical trial. 
     
     
         39 . The non-transitory storage medium of  claim 37 , wherein the instructions are further executable to perform operations comprising using a workflow palette and a visual programming toolkit, the user screens for the clinical trial. 
     
     
         40 . The non-transitory storage medium of  claim 39 , wherein the instructions are further executable to perform operations comprising:
 capturing in a specification document, associated inputs, state changes, outputs, and result status for test cases;   executing at least some 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; and   verifying application objects and application components.   
     
     
         41 . The non-transitory storage medium of  claim 40 , wherein the instructions are further executable to perform operations comprising providing compilation and subsystem linking services using a build engine. 
     
     
         42 . The non-transitory storage medium of  claim 40 , wherein the instructions are further executable to perform operations comprising accessing a composition studio configured to produce applications and the application components.