Electronic data document for use in clinical trial verification system and method

Abstract

The present invention provides an electronic data document (EDD) and related system and method for use in a computerized clinical trial verification system. In an exemplary embodiment, the EDD is authenticated by the creator and validated by the receiver, and comprises an image of a source document (SD) that comprises a masked record of at least one interaction between a clinical trial investigator and a patient enrolled in a clinical trial, at least one revealed portion of the SD that includes evidence relevant to at least one question in a clinical trial questionnaire, and at least one annotation connecting the revealed portion to the at least one question. The present invention provides a computerized system and method for allowing a clinical trial investigator to answer questions from a clinical trial questionnaire pertinent to a clinical trial of a medical treatment using encrypted and partially masked electronic documents comprising images of original patient records. The process of creating and viewing the partially masked electronic documents preferably does not create local copies that can be recalled later.

What is claimed is: 
     
         1 . A computerized system for answering at least one question in an electronic Case Report Form (eCRF) in a clinical trial study, the system comprising:
 at least one processor running an EMR system on a first device, wherein the EMR system includes at least one patient source document displayed on a display screen associated with the first device, the source document comprising a record of at least one data value associated with a patient enrolled in a clinical trial study;   the at least one processor providing a source document (SD) ingester, the SD document ingester configured to create a source document (SD) extraction, wherein the SD extraction consists of a selected graphical portion of the ingested SD; and   the at least one processor having a SD extraction markup tool, the SD extraction markup tool configured to allow the SD extraction to be stored associated with, and being designated as, being relevant to an answer of at least a portion of the at least one question in the eCRF.   
     
     
         2 . The computerized system of  claim 1 , wherein the at least one processor automatically recognizes text included within the SD extraction and applies the recognized text to answer the portion of the at least one question in the eCRF. 
     
     
         3 . The computerized system of  claim 1 , further comprising a masking tool for redacting one or more portions of the SD extraction. 
     
     
         4 . The method as recited in  claim 1 , further comprising the at least one processor including an electronic signature tool configured to allow the Investigator to associate an electronic signature with the SD extraction, thereby allowing the Investigator to confirm that the SD extraction comprises a graphical portion of information from the source document. 
     
     
         5 . The computerized system of  claim 3 , wherein the redacted one or more portions of the SD extraction are no longer part of the SD extraction. 
     
     
         6 . The computerized system of  claim 5 , wherein the redacted one or more portions of the SD extraction are not retained by the computerized system. 
     
     
         7 . The computerized system of  claim 3 , wherein the redacted one or more portions of the SD extraction include personally identifiable information. 
     
     
         8 . A method for answering at least one question in an electronic Case Report Form (eCRF) in a clinical trial study, the method comprising:
 running an EMR system on a first device, wherein the EMR system includes at least one patient source document displayed on a display screen associated with the first device, the source document comprising a record of at least one data value associated with a patient enrolled in a clinical trial;   ingesting a source document using a SD ingester, the SD document ingester configured to create a source document (SD) extraction, wherein the SD extraction consists of a selected graphical portion of the ingested SD; and   marking the SD extraction using a SD extraction markup tool, the SD extraction markup tool configured to allow the SD extraction to be stored associated with, and designated as, being relevant to an answer of at least a portion of the at least one question in the eCRF.   
     
     
         9 . The method as recited in  claim 8 , wherein the at least one processor automatically recognizes text included within the SD extraction and applies the recognized text to answer the portion of the at least one question in the eCRF. 
     
     
         10 . The method as recited in  claim 8 , further comprising redacting one or more portions of the SD extraction using a masking tool. 
     
     
         11 . The method as recited in  claim 8 , further comprising signing the SD extraction using an electronic signature tool configured to allow the Investigator to associate an electronic signature with the SD extraction, thereby allowing the Investigator to confirm that the SD extraction comprises a graphical portion of information from the source document. 
     
     
         12 . The method as recited in  claim 10 , wherein the redacted one or more portions of the SD extraction are no longer part of the SD extraction. 
     
     
         13 . The method as recited in  claim 12 , wherein the redacted one or more portions of the SD extraction are not retained by the computerized system. 
     
     
         14 . The method as recited in  claim 10 , wherein the redacted one or more portions of the SD extraction include personally identifiable information. 
     
     
         15 . An electronic data document (EDD) in a non-transitory computer-readable medium for use in a computerized clinical trial verification system, the system comprising:
 a first computer program running an EMR system on a first device that can be used to create the EDD, wherein the EMR system includes at least one patient source document displayed on a display screen associated with the first device, the source document comprising a record of at least one data value associated with a patient enrolled in a clinical trial; and   a second computer program that can read and modify the EDD, the EDD comprising: integrated computer instructions that are compatible with the first computer program and the second computer program and integrated with the EDD; ingesting a source document using a SD ingester, the SD document ingester configured to create a source document (SD) extraction, wherein the SD extraction consists of a selected graphical portion of the ingested SD; wherein the integrated computer instructions further comprise first computer instructions that permit marking the SD extraction using a SD extraction markup tool, the SD extraction markup tool configured to allow the SD extraction to be stored associated with, and designated as, being relevant to an answer of at least a portion of the at least one question on an electronic case report form (eCRF) in the computerized clinical trial verification system.   
     
     
         16 . The EDD as recited in  claim 15 , wherein the computer instructions further comprise second computer instructions that permit automatically recognizing text included within the SD extraction and applying the recognized text to answer the portion of the at least one question in the eCRF. 
     
     
         17 . The EDD as recited in  claim 15 , wherein the computer instructions further comprise third instructions that permit redacting one or more portions of the SD extraction using a masking tool. 
     
     
         18 . The EDD as recited in  claim 15 , wherein the computer instructions further comprise fourth instructions that permit signing the SD extraction using an electronic signature tool configured to allow the Investigator to associate an electronic signature with the SD extraction, thereby allowing the Investigator to confirm that the SD extraction comprises a graphical portion of information from the source document. 
     
     
         19 . The EDD as recited in  claim 17 , wherein the redacted one or more portions of the SD extraction are no longer part of the SD extraction. 
     
     
         20 . The EDD as recited in  claim 19 , wherein the redacted one or more portions of the SD extraction are not retained by the computerized system. 
     
     
         21 . The EDD as recited in  claim 17 , wherein the redacted one or more portions of the SD extraction include personally identifiable information.