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Ensuring Data Integrity and Safety in Clinical Research

Overview: Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why should you Attend: The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed. Areas Covered in the Session: The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid?

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