US 2023/0410955 A1 · 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.

Claims21

Dependent claims

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.

1 more element

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.

3 more elements

Dependencies are inferred from the claim text.

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

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

Life of this patent

Abstract

Claims21