We try to require PI effort on the industry sponsored clinical trials (though we don't always succeed), the theory being that they must be contributing in some fashion to the trial. Our stance is that some effort is significant when compare to no effort. They may have 1% on the grant, and it may not be consistent month by month ~ that's ok. A problem I have with 0% effort on the grant is that they receive inflated residual ~ which isn't appropriate. To the extent where residual balances occur, we risk UBIT (unrelated business income tax)which could be substantial, so reporting full cost is necessary for that reason as well.
"Children's Grant Accounting office provides quality service backed by over 20 years experience in federal and non federal grant and contract accounting, reporting, and compliance."
Linda Ward, MBA
Grant Accounting Manager
Grant Accounting 35-123A
Children's Hospitals and Clinics of Minnesota
2910 Centre Pointe Dr.
Roseville, MN 55113
651-855-2603
651-855-2690 Fax
email: xxxxxx@childrensmn.org
>>> Lesley Zajac <xxxxxx@JAEB.ORG> 12/22/2009 8:29 AM >>>
We account for PI effort on industry sponsored trials in the same way
that we do for NIH sponsored trials, to ensure that total effort does
not exceed 100%. I assume from your question that PI effort was not
included in the study budget or was included at a much lower percent
FTE?
Lesley S. Zajac
Director, Research Administration
Jaeb Center for Health Research
15310 Amberly Drive, Ste 350
Tampa, FL 33647
Tel: 813.975.8690
Fax: 813.975.8761
email: xxxxxx@jaeb.org
-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org] On
Behalf Of Jamie Kauwell
Sent: Tuesday, December 22, 2009 9:18 AM
To: xxxxxx@hrinet.org
Subject: [RESADM-L] PI Effort on Industry-Sponsored Studies
Good Morning,
How do you account for PI time and effort for industry-sponsored
studies? Do you require time and effort for each trial? We are finding
that PI effort is having a significant impact on the study budget.
Many of you are probably out of the office, but for those of you still
working I would appreciate your feedback.
Happy Holidays!
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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