Abstract: The present disclosure is related to systems and methods for hashing-based assessment of electronic clinical trial outcomes. Such systems and methods may advantageously enable secure, rapid, efficient, and cost-effective reuse of pre-built eCOA assessments for clinical trials. In an aspect, the present disclosure provides a computer-implemented method for validation of an electronic clinical trial outcome assessment (eCOA), comprising: (a) obtaining an assessment of an eCOA, the assessment comprising a plurality of files generated by performing a first validation of the eCOA; (b) obtaining a first hash value associated with the assessment of the eCOA, the first hash value generated by hashing the plurality of files of the assessment of the eCOA; (c) hashing the plurality of files of the assessment of the eCOA to generate a second hash value; and (d) validating the eCOA when the second hash value is equal to the first hash value.

Abstract: Provided herein are systems, methods, and computer readable medium for entering, identifying, and aggregating data for analysis data in an electronic device, wherein the data are from a plurality of multi-participant surveys.

Abstract: Described here are methods, devices and systems for characterizing a physiological signal such as an electrocardiogram (ECG) signal. Generally, the method includes receiving the ECG signal generated by an ECG device coupled to a patient. ECG signal quality for a plurality of consecutive beats may be determined based on a dispersion coefficient and a deviation from an average of each of a plurality of ECG parameters. Indexing information may be generated for set of sequences from the plurality of consecutive cardiac beats. Each of the sequences may comprise a first predetermined number of consecutive cardiac beats. The set of the sequences may be ordered based upon the ECG signal quality.

Abstract: A system and method for displaying a non-biasing VAS that automatically adjusts to different screen aspect ratios/resolutions of a computing device, while preserving the reliability of the VAS. The system and method can calculate a number of pixels available on a screen display to display a VAS. Further, the system and method can generate a VAS comprising equally sized intervals of distance to fit the available screen display. In addition, the system and method can include an anchor line at each end of the VAS that indicates an upper and lower value of a range of values measured by the VAS. The system and method can also include a unit cursor on the VAS that allows a subject to indicate, by pixel, interval or target area, a position on the VAS.

Abstract: Provided herein are systems, methods, and computer readable medium for entering, identifying, and aggregating data for analysis data in an electronic device, wherein the data are from a plurality of multi-participant surveys.

Abstract: A system for developing and producing clinical endpoints based on patient reported outcome data utilizing algorithms to generate decision rules to evaluate patient reported outcome type questionnaire is provided. The questionnaires can include health-related quality of life questionnaires and can predict the reliability of endpoints in supporting one or more medical labeling claims.

Abstract: A system for developing and implementing empirically derived algorithms to generate decision rules to predict invalidity of subject reported data and fraud with research protocols in surveys allows for the identification of complex patterns of variables that detect or predict subject invalidity of subject reported data and fraud with the research protocol in the survey. The present invention may also be used to monitor invalidity of subject reported data within a research protocol to determine preferred actions to be performed. Optionally, the invention may provide a spectrum of invalidity, from minor invalidity needing only corrective feedback, to significant invalidity requiring subject removal from the survey. The algorithms and decision rules can also be domain-specific, such as detecting invalidity or fraud among subjects in a workplace satisfaction survey, or demographically specific, such as taking into account gender or age.

Abstract: In a method and system for processing an electrocardiogram (ECG), digital ECG data are received. The digital ECG data evinces a plurality of a patient's heartbeats detected during an ECG. Digital annotation data are generated representing marking to be shown on an ECG tracing of the plurality of heartbeats. An annotated ECG tracing image is produced using the digital ECG data and the digital annotation data.

Abstract: In a method and system for processing an electrocardiogram (ECG), digital ECG data are received. The digital ECG data evinces a plurality of a patient's heartbeats detected during an ECG. Digital annotation data are generated representing marking to be shown on an ECG tracing of the plurality of heartbeats. An annotated ECG tracing image is produced using the digital ECG data and the digital annotation data.

Abstract: In a method and system for processing an electrocardiogram (ECG), digital ECG data are received. The digital ECG data evinces a plurality of a patient's heartbeats detected during an ECG. Digital annotation data are generated representing marking to be shown on an ECG tracing of the plurality of heartbeats. An annotated ECG tracing image is produced using the digital ECG data and the digital annotation data.