Clinical trials management system and method

Abstract

System and method of managing a clinical trial in accordance with a protocol are provided. In accordance therewith, a workflow associated with the protocol is accessed from a first data structure. The workflow includes a plurality of workflow tasks to be performed in connection with treatment of a plurality of patients according to the protocol. Instruction is provided to clinical personnel to perform one or more workflow tasks according to the workflow in connection with a visit of a patient out of a plurality of visits. Progress of the patient through the workflow is recorded to a second data structure as performance or non-performance of the one or more workflow tasks in connection with the visit on a per-visit basis.

What is claimed is: 
     
         1 . A method of managing a clinical trial in accordance with a protocol, the method comprising:
 accessing, using a computing device, from a first data structure a workflow associated with the protocol, the workflow comprising a plurality of workflow tasks to be performed in connection with treatment of a plurality of patients according to the protocol;   providing, using the computing device, instruction to clinical personnel to perform one or more workflow tasks according to the workflow in connection with a visit of a patient out of a plurality of visits; and   recording, using the computing device, to a second data structure progress of the patient through the workflow as performance or non-performance of the one or more workflow tasks in connection with the visit on a per-visit basis.   
     
     
         2 . The method of  claim 1 , wherein the plurality of workflow tasks comprises one or more patient management tasks. 
     
     
         3 . The method of  claim 2 , wherein the one or more patient management tasks comprise at least one of obtaining medical information from the patient, taking a clinical assessment of the patient, administering a drug to the patient, and taking a clinical measurement associated with the patient. 
     
     
         4 . The method of  claim 3 , wherein the clinical personnel is instructed to obtain medical information from the patient before or after the clinical personnel is instructed to obtain informed consent from the patient. 
     
     
         5 . The method of  claim 1 , wherein the plurality of workflow tasks comprises one or more data management tasks. 
     
     
         6 . The method of  claim 5 , wherein the one or more data management tasks comprise at least one of obtaining informed consent from the patient, scheduling a follow up to obtain informed consent from the patient, enrolling the patient in the clinical trial, entering a clinical assessment of the patient, completing a form associated with the visit, and submitting the form associated with the visit. 
     
     
         7 . The method of  claim 1 , wherein the method further comprises transmitting the progress of the patient through the workflow to a centralized data structure. 
     
     
         8 . The method of  claim 1 , wherein the first data structure is encoded with a protocol schema comprising the workflow tasks. 
     
     
         9 . The method of  claim 8 , wherein the method further comprises representing the protocol schema as a graph showing connections of the workflow tasks. 
     
     
         10 . The method of  claim 10 , wherein the graph provides instructions of timing associated with the workflow tasks. 
     
     
         11 . A system to manage a clinical trial in accordance with a protocol, the system comprising:
 a computing device;   a memory device storing instructions that, when executed by the computing device, cause the computing device to perform operations comprising:
 accessing from a first data structure a workflow associated with the protocol, the workflow comprising a plurality of workflow tasks to be performed in connection with treatment of a plurality of patients according to the protocol; 
 providing instruction to clinical personnel to perform one or more workflow tasks according to the workflow in connection with a visit of a patient out of a plurality of visits; and 
 recording to a second data structure progress of the patient through the workflow as performance or non-performance of the one or more workflow tasks in connection with the visit on a per-visit basis. 
   
     
     
         12 . The system of  claim 11 , wherein the plurality of workflow tasks comprises one or more patient management tasks. 
     
     
         13 . The system of  claim 12 , wherein the one or more patient management tasks comprise at least one of obtaining medical information from the patient, taking a clinical assessment of the patient, administering a drug to the patient, and taking a clinical measurement associated with the patient. 
     
     
         14 . The system of  claim 13 , wherein the clinical personnel is instructed to obtain medical information from the patient before or after the clinical personnel is instructed to obtain informed consent from the patient. 
     
     
         15 . The system of  claim 11 , wherein the plurality of workflow tasks comprises one or more data management tasks. 
     
     
         16 . The system of  claim 15 , wherein the one or more data management tasks comprise at least one of obtaining informed consent from the patient, scheduling a follow up to obtain informed consent from the patient, enrolling the patient in the clinical trial, entering a clinical assessment of the patient, completing a form associated with the visit, and submitting the form associated with the visit. 
     
     
         17 . The system of  claim 11 , wherein the operations further comprise transmitting the progress of the patient through the workflow to a centralized data structure. 
     
     
         18 . The system of  claim 11 , wherein the first data structure is encoded with a protocol schema comprising the workflow tasks. 
     
     
         19 . The system of  claim 18 , wherein the operations further comprise representing the protocol schema as a graph showing connections of the workflow tasks. 
     
     
         20 . The system of  claim 19 , wherein the graph provides instructions of timing associated with the workflow tasks. 
     
     
         21 . A non-transitory computer readable medium storing instructions that, when executed by a computing device, cause the computing device to perform operations comprising:
 accessing from a first data structure a workflow associated with the protocol, the workflow comprising a plurality of workflow tasks to be performed in connection with treatment of a plurality of patients according to the protocol;   providing instruction to clinical personnel to perform one or more workflow tasks according to the workflow in connection with a visit of a patient out of a plurality of visits; and   recording to a second data structure progress of the patient through the workflow as performance or non-performance of the one or more workflow tasks in connection with the visit on a per-visit basis.   
     
     
         22 . The medium of  claim 21 , wherein the plurality of workflow tasks comprises one or more patient management tasks. 
     
     
         23 . The medium of  claim 22 , wherein the one or more patient management tasks comprise at least one of obtaining medical information from the patient, taking a clinical assessment of the patient, administering a drug to the patient, and taking a clinical measurement associated with the patient. 
     
     
         24 . The medium of  claim 23 , wherein the clinical personnel is instructed to obtain medical information from the patient before or after the clinical personnel is instructed to obtain informed consent from the patient. 
     
     
         25 . The medium of  claim 21 , wherein the plurality of workflow tasks comprises one or more data management tasks. 
     
     
         16 . The medium of  claim 15 , wherein the one or more data management tasks comprise at least one of obtaining informed consent from the patient, scheduling a follow up to obtain informed consent from the patient, enrolling the patient in the clinical trial, entering a clinical assessment of the patient, completing a form associated with the visit, and submitting the form associated with the visit. 
     
     
         27 . The system of  claim 21 , wherein the operations further comprise transmitting the progress of the patient through the workflow to a centralized data structure. 
     
     
         28 . The medium of  claim 21 , wherein the first data structure is encoded with a protocol schema comprising the workflow tasks. 
     
     
         29 . The medium of  claim 28 , wherein the operations further comprise representing the protocol schema as a graph showing connections of the workflow tasks. 
     
     
         30 . The medium of  claim 29 , wherein the graph provides instructions of timing associated with the workflow tasks.