Confidentiality Question Jamie Kauwell 06 Feb 2009 15:10 EST

Good Afternoon,
We have a sponsor who is insisting that we include "other regulatory agencies that approve medicines in other countries" in our ICF under Confidentiality pertaining to who may inspect records.

Our IRB is asking us to include a list of the "other regulatory agencies" as an attachment to the ICF because the sponsor is stating that those agencies can come into our facility to audit our records.

Has anyone encounter this issue? If so, how was it resolved?

Thanks so much,
Jamie

Jamie Kauwell MHA CCRC
Administrative Research Coordinator
Geisinger Center for Clinical Studies
Henry Hood Center for Health Research
100 N. Academy Ave
Danville, PA  17822-4400
Phone# 570-214-9405
Fax# 570-271-6944
xxxxxx@geisinger.edu

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