ARTICLE
20 September 2017

FDA Issues Draft Guidance On Electronic Privacy, Security, And Reliability Criteria For Clinical Trial Records

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Jones Day

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In June, the Food and Drug Administration ("FDA") published draft guidance on electronic privacy requirements for clinical trial records.
United States Food, Drugs, Healthcare, Life Sciences

In June, the Food and Drug Administration ("FDA") published draft guidance on electronic privacy requirements for clinical trial records. The guidance details: (i) "Procedures that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and that the records and signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper"; and (ii) "the use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records...." For more information, see the Jones Day Alert.

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