United States:
FDA Issues Draft Guidance On Electronic Privacy, Security, And Reliability Criteria For Clinical Trial Records
20 September 2017
by
Daniel J. McLoon
,
Mauricio Paez
,
Richard Johnson
,
Jonathon Little
,
Kevin Lyles
,
Todd McClelland
,
Jeff Rabkin
,
Lisa M. Ropple
,
Adam Salter
,
Michiru Takahashi
,
Undine Von Diemar
,
Olivier Haas
,
Jörg Hladjk
and
Anand Varadarajan
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published draft guidance on electronic privacy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. 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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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