Transfer of identifiable data outside the EU is subject to authorization by
the national data protection agency unless covered by the exemptions.
Has anyone any experience with clinical trial data? My question concerns
identifiable patient data (randomization number) from European-based trials
that the FDA might request in connection with a marketing application for a
new drug in the USA.
If this eventuality had not been foreseen and addressed in the patient
informed consent, would you need to obtain authorization from your DP
agency to transfer the data?
Thanks in advance for any answers,
Susan Vaillant
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