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An electronic data capture EDC system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.

EDC solutions are widely adopted by pharmaceutical companies and contract research organizations CRO. EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, [2] but are particularly beneficial for late-phase phase III-IV studies and pharmacovigilance and post-market safety surveillance.

EDC can increase data accuracy and decrease the time to collect data for studies of drugs and medical devices. As a result, for an EDC to be economical the saving over the life of the trial must be greater than the set-up costs. This is often aggravated by two conditions:. The net effect is to increase both the cost and risk to the study with insignificant benefits. However, with the maturation of today's EDC solutions, much of the earlier burdens for study design and set-up have been alleviated through technologies that allow for point-and-click , and drag-and-drop design modules.

EDC is often cited as having its origins in remote data entry RDE software, which surfaced in the life sciences market in the late s and early s. Nichol, Pickering, and Bollert offered "a controlled system for post-marketing surveillance PMS of newly approved NDA pharmaceutical products," with surveillance data being "entered into an electronic data base on site" at least as early as Clinical research data—patient data collected during the investigation of a new drug or medical device is collected by physicians, nurses, and research study coordinators in medical settings offices, hospitals, universities throughout the world.

Historically, this information was collected on paper forms which were then sent to the research sponsor e. To address these and other concerns, RDE systems were invented so that physicians, nurses, and study coordinators could enter the data directly at the medical setting.

By moving data entry out of the sponsor site and into the clinic or other facility, a number of benefits could be derived: [5].

These early RDE systems used " thick client " software—software installed locally on a laptop computer's hardware—to collect the patient data. The system could then use a modem connection over an analog phone line to periodically transmit the data back to the sponsor, and to collect questions from the sponsor that the medical staff would need to answer.

Though effective, RDE brought with it several shortcomings as well. The most significant shortcoming was that hardware e. Usability and space constraints led to a lot of dissatisfaction among medical practitioners. With the rise of the internet in the mids, the obvious solution to some of these issues was the adoption of web-based software that could be accessed using existing computers at the investigational sites.

EDC represents this new class of software. Today, the market consists of a variety of new and established software providers. Many of these providers offer specialized solutions targeting certain customer profiles or study phases. Modern features of EDC now include features like cloud data storage, role-based permissions, and case report form designers, [1] as well as clinical trials analytics, interactive dashboards, and electronic medical record integration. In , the U.

Food and Drug Administration FDA introduced its eSource guidance, which suggests methods of capturing clinical trial data electronically from the very beginning and moving it to the cloud, as opposed to EDC's more traditional method of capturing data initially on paper and transcribing it into the EDC system.

From Wikipedia, the free encyclopedia. Typically, EDC systems provide: a graphical user interface component for data entry a validation component to check user data a reporting tool for analysis of the collected data EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, [2] but are particularly beneficial for late-phase phase III-IV studies and pharmacovigilance and post-market safety surveillance.

This is often aggravated by two conditions: that initial design of the study in EDC does not facilitate the decrease in costs over the life of the study due to poor planning or inexperience with EDC deployment; and initial set-up costs are higher than anticipated due to initial design of the study in EDC due to poor planning or experience with EDC deployment.

In Urquhart, C. Information Systems: Process and Practice. Facet Publishing. ISBN Retrieved 24 May SAS Institute Inc. Archived from the original on Retrieved Business Briefing, Pharmatech.

Archived from the original PDF on Bibcode : PLoSO PMC PMID S2CID Contemporary Clinical Trials. In Rondel, R. Clinical Data Management. November International Clinical Trials. Archived from the original PDF on 2 May Business Wire. Archived from the original on 25 May Categories : Clinical research Telemetry Clinical data management. Namespaces Article Talk. Views Read Edit View history. Help Learn to edit Community portal Recent changes Upload file. Download as PDF Printable version.

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