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International Clinical Trials
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Streamlining clinical research, particularly data acquisition, through the use of technology dates back to the 1990s with ‘remote data entry’, which was quickly renamed ‘electronic data capture’ (EDC) to reflect that data were being entered at investigative sites that were not ‘remote’, but rather the actual source of the data. While EDC technologies slowly gained traction, regulators were faced with the challenge of translating regulations written for paper-based processes to the new world of EDC. ‘The Final Rule for FDA Title 21, CFR Part 11: Electronic Records; Electronic Signatures’ was released in 1997 and generated numerous industry presentations, scenarios, and discussions related to the implementation of this regulation (1). Topics addressed included detailed analyses of aspects such as the source of the data, who had control of the data at a given point in the process, closed vs open systems, validation requirements, and change control procedures to maintain an audit trail. The FDA had authority to inspect these systems, and they needed to develop methods and training so that auditors could review electronic audit trails and validation documents.
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About the author
Rebecca D Kush, PhD, is Chief Scientific Officer for Elligo Health Research, President of Catalysis Research, and Fellow for Japan’s Translational Research Innovation Center. She is the Founder and President Emeritus of CDISC, a global non-profit standard development organisation. She has over 40 years of experience in medical research and related process improvement, technology, and standards, serving on multiple boards and advisory groups. She participated in developing a consensus document on data sharing through the EU CORBEL Initiative. She earned her doctorate in Physiology and Pharmacology from UC San Diego School of Medicine, US, and a BSc in Biology and Chemistry with honours from the University of New Mexico, US.
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