Abstract: An electronic data document (EDD) and related system and method for use in a computerized clinical trial verification system is provided. 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. 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 is provided.

Abstract: The present invention provides a computerized system and method for allowing a person from the medical site, such as at least one medical professional (Investigator) to answer questions from a clinical trial questionnaire (such as an electronic case report form (eCRF)) pertinent to a clinical trial of a medical treatment by performing a source capture and delineating specific areas of the source capture image that contain an answer. The system enables a workflow, whereby an image of an answer, for example, a screenshot capture snippet, obtained through mouse clicks is used instead of transcription of alphanumeric values.

Abstract: A system and method that allows the usage of an electronic data document as a means with which to map the database fields in an electronic health record to a question on a clinical report form using an application programming interface. The electronic data document can associate a clinical report form question with a source capture from an electronic health record by correlating it via a snippet to the content on the source capture that can then be confirmed by a user. Positive matches can lead to a streamlined process where the same question on the clinical report form during a future visit with the patient results in the electronic data document system automatically pulling the answer from the electronic health record via the application programming interface using the previously defined field identifier and populating it into the case report form.

Abstract: An improvement to a clinical trial study workflow system and method providing a method for electronic verification of a source for a source capture in a clinical trial workflow system, the method including opening an EMR system, logging into the EMR system on behalf of a user using securely stored credentials, automatically selecting correct navigation links of the EMR system and filling out the appropriate navigation forms to reach an EMIR page with desired information for a correct study subject's record and visit date, capturing one or more screenshots of one or more relevant pages containing the desired information for answering one Nor more questions on a case report form (CRF), and verifying that the one or more captured screenshots is of the correct study subject by using one or more data points for verification.

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.

Abstract: The present invention provides a system and method for converting unstructured data into structured data to respond to at least one question on an electronic case report form, including taking a source capture of a portion of an electronic health record (EHR), converting unstructured data on the source capture into alphanumeric data, cross referencing the alphanumeric data with a library of terms and presenting one or more users with a list of suggestions for a response, the one or more users each selecting a user response from the list of suggestions, and reviewing the one or more user responses and selecting a final response, thereby converting the unstructured data to structured data.

Abstract: A computerized system and method for completing an electronic Case Report Form (eCRF) in a clinical trial study, the system including at least one processor maintaining the eCRF on a first device, at least one processor maintaining and displaying a source document (SD) containing information relevant to at least one question in the eCRF, at least one processor for creating a source capture (SC) that is at least a portion of the SD, at least one processor enabling a verification system for automatically marking the SC as verified or marking the SC as unverified, and at least one processor maintaining a video conference system, wherein the video conferencing system may be activated to allow a remote user to review the SC and change the verification status of the SC.

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.

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.

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.