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published draft guidance on electronic privacy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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