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: A method includes providing one or more instructions to perform a first action associated with administration of a medication; obtaining first data representing a capture of a patient performing the first action based on the one or more instructions as output by the output device; extracting information about movements of the patient from the first data; presenting an image configured to induce an emotional response in the patient; obtaining second data representing capture of the patient performing one or more microexpressions in response to presentation of the image; obtaining additional data including one or more of demographic information of the patient, information of a disease associated with the patient, or one or more characteristics of the medication; and based on the extracted information about the movements, the one or more microexpressions, and the additional data, determining a medical outcome including a progression of the disease in the patient.

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: A method includes providing one or more instructions to perform a first action associated with administration of a medication; obtaining first data representing a capture of a patient performing the first action based on the one or more instructions; extracting information about movements of the patient from the first data; presenting an image configured to induce an emotional response in the patient; obtaining second data representing capture of the patient performing one or more microexpressions within 250 milliseconds of presentation of the image; obtaining additional data including one or more of demographic information of the patient, information of a disease associated with the patient, or one or more characteristics of the medication; and based on the extracted information about the movements, the one or more microexpressions, and the additional data, determining a medical outcome including a progression of the disease in the patient.

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.

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.

Abstract: An apparatus for the display of artwork including a central box, the central box housing the artwork, a lighting tray located above the central box, the lighting tray housing lights that shine into the central box onto the artwork, a lighting power source, and a peephole in the central box, the peephole having a convex lens.

Abstract: An apparatus for monitoring changes in symptoms of a patient is described. The apparatus includes a display for displaying information to a patient; a processing system configured to output to the display at least one of audio, video or both audio and video stimuli for eliciting a reaction in the patient; an audio and video capture device for capturing audio, video or both audio and video recordings of the patient performing an action as the stimuli is output by the display; a computer vision processor configured to determine from the audio, video or both audio and video recordings, one or more reactions of the patient in response to the stimuli and during a first period of time immediately after presentation of the stimuli to the patient, wherein the first period of time is less than 250 milliseconds.

Abstract: A system for user-initiated analysis of changes in symptoms of a patient is described. The system includes a storage device for storing data captured of a patient performing an action in response to a stimulus presented to the patient. The stimulus presented to the patient includes one or more instructions provided to the patient in accordance with monitoring of medication administration of the patient. The action performed in response to the stimulus presented to the patient includes the action of the patient performing a requested step indicative of proper medication administration and is indicative of a change in one or more symptoms associated with a disease and the overall progression of the disease, the storage device further storing one or more item selected from the group of: demographic information of the patient, disease progression information of the patient, and one or more medication characteristics of the medication subject to the medication administration monitoring process.

Abstract: An apparatus for analyzing changes in symptoms of a patient is described.