Patent ID: 8805483

Claim:
A system for automated processing of electrocardiograms (ECGs) in one or more sponsor trials comprising: one or more data storage units; a processor unit programmed with: a trial setup module configured to receive protocol parameters for a sponsor trial and to store the protocol parameters in the one or more data storage units, said protocol parameters identifying data to be collected for ECGs processed in the sponsor trial and rules governing the sponsor trial; a data entry module configured to receive the data to be collected as dictated by the protocol parameters for the sponsor trial received by the trial setup module and to store the data in the one or more data storage units; a query resolution module configured to automatically identify problems with the data received with and stored by the data entry module and automatically generate a query for prompting resolution of the problems; an interval duration measurement module configured to receive and store in the one or more data storage units interval duration measurements for the ECGs processed in the sponsor trial, the interval duration measurements obtained through on-screen measurement of ECG intervals by a technician; a cardiologist evaluation module configured to present the ECG interval duration measurement data to a cardiologist for the ECGs processed in the sponsor trial, to receive and store in the one or more data storage units cardiological evaluation of the ECGs for which the ECG interval duration measurement data is presented, to queue uncertified ECGs for which the ECG interval duration measurement data is presented to the interval duration measurement module for interval remeasurement using the interval duration measurement module in response to cardiologist input designating the ECGs for remeasurement, and to receive certification of an evaluated ECG from the cardiologist; and a reporting module for automatically generating a report representing the cardiological evaluation for an evaluated ECG that has been certified through the cardiologist evaluation module; and a user terminal comprising a processor, a monitor and an input device, wherein the user terminal is configured to display an image of an ECG on the monitor for on-screen measurement of ECG intervals by the technician, generate an annotation file linked to an ECG file corresponding to the displayed ECG, the annotation file representing annotations corresponding to the on-screen measurement of the ECG intervals, and provide the interval duration measurements for the interval duration measurement module, wherein the query resolution module is configured to classify each of the problems based on whether outside contact interaction is needed to resolve the problem, generate an internal alert if outside contact interaction is not required and generated an external query if outside contact interaction is required.