System and method for managing medical data

#This invention relates generally to systems and methods for managing medical data, and more particularly to managing electrocardiogram data in connection with a clinical trial.

#Various types of patient medical data are valuable pieces of information with respect to a variety of medical practices. These medical practices may include treating, diagnosing, monitoring, and performing clinical trials. Clinical trials are often performed to determine the effect a particular drug may have on a particular type of patient or patients in general. During clinical trials, medical data regarding participating patients needs to be submitted over a period of time. For example, medical data may be required to be submitted before receiving a drug, on a periodic basis while taking a drug, and after the patient has stopped taking the drug.

#One type of medical data commonly required during a clinical trial is data from an electrocardiogram (ECG or EKG). To obtain an ECG, medical personnel attach up to 12 leads to various areas on a patient's body. The leads are connected to a device that is able to monitor and record, electronically, the electrical signals measured by the leads with respect to time. The device may be able to display the obtained measurements graphically.

#FIG. 1 schematically shows a flow diagram of a data management method according to one embodiment of the invention.

#FIG. 2 schematically shows the components of a system which implements the data management method according to one embodiment of the invention.

#FIG. 3 schematically shows a flow diagram of a workflow related system according to one embodiment of the invention.

#FIG. 1 shows a flow diagram of a data management process and procedure according to one embodiment of the present invention. According to the particular embodiment illustrated in FIG. 1, ECG data is collected 10 from an ECG performed at a clinical testing center. The ECG 10 is preferably administrated by trained medical personnel such as a nurse, doctor, or clinical technician. ECG data is preferably obtained using a plurality of leads attached to various points on the patient's body. An electrical measurement is read from each lead over a period of time and this data is collected and placed in graph format showing voltage or other electrical parameters along with time relative to the starting time. The ECG data is then associated 12 with patient information. Patient information includes demographics such as a patient number associated with the particular patient, date of birth, gender, visit number, date, and time, and testing site number. Patient information is preferably electronically associated 12 with the digital ECG data.

#After the patient information is associated with the ECG data 12, the information is transmitted electronically to a server through a network 14. The information is preferably transmitted in digital format. The server 14, which may be located at any location as long as it may be in communication with the network 14, may manipulate the data into a variety of formats for further data management. Preferably, the ECG data is changed into Extensible Markup Language (XML) format. XML format allows the creation of customized tags or metadata that enable the definition, transmission, validation, and interpretation of data between applications and between organizations. In addition, the server preferably transmits a validation signal 11 to the testing center 10 to validate that the information arrived at the server 14.

#If a particular patient's ECG data has not reached the server 14 by a certain time, the server preferably transmits a reminder signal 13 to the testing center 10 indicating that a particular patient's ECG data has not been received by the server 14 and that the particular ECG data is overdue. The server 14 may transmit a reminder signal 13 when, for example, the patient has not appeared at the testing center by a scheduled date or an error in the system occurred and the ECG data never reached the server 14.