The Future of Clinical Trials Using Electronic Data Capture Systems

Adam Donat, MS, Martin Hamilton, MSN-FNP, Irfan Khan, MS, Nichole Chamberlain, MSN-FNP

Organization:   Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring

The findings and conclusions in this article should not be construed to represent any Agency determination or policy.

Technology continues to permeate every facet of the modernized world. As the medical field relies more and more on computerized technology, unique issues have emerged especially in the area of clinical trials and the use of Electronic Data Capture (EDC). Novel approaches to safeguard data integrity and human subjects need to be considered at every juncture of the research process.

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