Hi,

The sponsor's access to the study records is dictated by the contractual agreement between the institution and the sponsor.  I should think the informed consent and HIPAA access to PHI language would be consistent with the agreement between the sponsor and the institution.  IRB closure is not the issue.

Steve

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org] On Behalf Of Jamie Kauwell
Sent: Thursday, December 10, 2009 3:22 PM
To: xxxxxx@hrinet.org
Subject: [RESADM-L] Industry Sponsors Access to Records

Good Afternoon,
We have had discussions around what an industry sponsor would have access to after the study is closed with the IRB.

Is the sponsor allowed to access the subjects electronic medical record after the study is closed with the IRB?
Would you allow them to access the records that the sponsor would have previously had access to, but nothing new?

Thank you,
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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