To the best of my knowledge, no regulatory approval is required to set up a registry. The question is whether any given regulatory agency will accept the data in it to support regulatory approval or other regulatory requirements (eg, postmarket surveillance).
It's my impression that FDA is in the very early stages of struggling with the potential use of registries for regulatory something, under the fuzzy umbrellas of "real-world evidence" and "patient engagement." As of the second meeting of its Patient Engagement Advisory Committee last fall, it seemed to have progressed to the point of identifying these key (and interrelated) issues: data integrity, data security, patient privacy, and patient consent. All of these issues are significantly complicated by cloud storage, I think.
If I were in dire need of a registry to address some type of FDA requirement, I personally would not put it in the cloud at this time. I think these issues are challenging enough already. If I were not in dire need of a registry to address some type of FDA requirement, I think I might wait this one out a bit, until FDA has gotten farther along on a road that may be a long and challenging one, and it's too soon to tell if it is likely to lead to a happy ending. I think two years from now, things will be much clearer.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 20-Jan-2019 01:57
From: Rashmi Pillay
Subject: Registry -patient data
Hi,
Does anybody know about patient data registries and can such registries be cloud based? Does this require regulatory approval? Do the regulations differ for the various geographies?
This is a new subject for me and any guidance in this regard will be helpful.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
W ellex.com
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