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 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;   the at least one processor providing a source document (SD) ingester, the SD document ingester configured to create a source document (SD) snippet, wherein the SD snippet consists of text automatically recognized and output by computer screen capture software installed on the first device; and   the at least one processor having a SD snippet markup tool, the SD snippet markup tool configured to allow the SD snippet to be selected as relevant to the answer of at least a portion of the at least one question in the eCRF.   
     
     
         2 . The computerized system as recited in  claim 1 , wherein at least one question is superimposed on the first device display screen. 
     
     
         3 . The computerized system as recited in  claim 1 , wherein the SD snippet is not saved to the first device. 
     
     
         4 . The computerized system as recited in  claim 1 , wherein the SD snippet is handled independently of the first device native operating system. 
     
     
         5 . The computerized system as recited in  claim 1 , further comprising the at least one processor including an electronic signature tool configured to allow an electronic signature with the SD snippet, wherein the electronic signature confirms the SD snippet is representative of information from the source document. 
     
     
         6 . 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 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 with a source document (SD) ingester;   creating a source document (SD) snippet, wherein the SD snippet consists of text automatically recognized and output by computer screen capture software installed on the first device; and   marking the SD snippet using a SD snippet markup tool, wherein the SD snippet markup tool is configured to allow the SD snippet to be selected as relevant to the answer of at least a portion of the at least one question in the eCRF.   
     
     
         7 . The method as recited in  claim 6 , further comprising superimposing the at least one question on the display associated with the first device. 
     
     
         8 . The method as recited in  claim 6 , wherein the SD snippet is not saved to the first device. 
     
     
         9 . The method as recited in  claim 6 , wherein the SD snippet is handled independently of the first device native operating system. 
     
     
         10 . The method as recited in  claim 6 , further comprising signing the SD snippet using an electronic signature tool, wherein the electronic signature tool is configured to associate an electronic signature with the SD snippet, wherein the electronic signature provides confirmation that the SD snippet is representative of information from the source document. 
     
     
         11 . 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 that can be used to create the EDD and running an EMR system on a first device, wherein the EMR system includes at least one patient source document displayed on a display 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 with a SD ingester, wherein the integrated computer instructions further comprise:
 first computer instructions that permit creating a source document (SD) snippet, wherein the SD snippet consists of text automatically recognized and output by computer screen capture software installed on the first device; and 
 second computer instruction that permit marking the SD snippet using a SD snippet markup tool, wherein the SD snippet markup tool is configured to allow the SD snippet to be selected as relevant to the answer of at least a portion of the at least one question in an electronic case report form (eCRF) in the computerized clinical trial verification system. 
   
     
     
         12 . The EDD as recited in  claim 11 , wherein the computer instructions further comprise third computer instructions that permit superimposing the at least one question on the display associated with the first device. 
     
     
         13 . The EDD as recited in  claim 11 , wherein the SD snippet is not saved to the first device. 
     
     
         14 . The EDD as recited in  claim 11 , wherein the SD snippet is handled independently of the first device’s native operating system. 
     
     
         15 . The EDD as recited in  claim 11 , wherein the computer instructions further comprise fourth computer instructions that permit signing the SD snippet using an electronic signature tool, wherein the electronic signature tool is configured to associate an electronic signature with the SD snippet, wherein the electronic signature provides confirmation that the SD snippet is representative of information from the source document.