Transcript Scenario 1

Reporting Scenario # 1
September 18, 2005
Scenario # 1
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A pancreas is used to prepare islets
under IND. The donor was a victim
in a motor vehicle accident.
The accompanying records
(including donor eligibility
determination) are complete.
The pancreas appears in good
condition.
This islet product meets release
criteria.
The islet product is administered the
next day.
Scenario # 1
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48 hrs after receipt of the pancreas,
the OPO notifies the lab that drug
paraphernalia was found in the
donor’s car.
The donor’s mother denied
knowledge of drug use.
Assessment of the cadaver did not
reveal evidence of drug use.
The drug screen is pending.
The clinical protocol requires that
the donors meet FDA HCT/P donor
eliqibility criteria.
Scenario # 1
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Is this an adverse event?
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No (but after the product is
licensed, this would be
considered a reportable
biological product deviation).
Scenario # 1
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If an adverse event, is the event
serious?
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Not applicable, no AE occurred.
Scenario # 1
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Is this reportable to the FDA? If
so, how should it be reported?
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This is not reportable as an IND
safety report. However, it
should be documented in your
records and included in IND
annual report.
Scenario # 1
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What else should you do?
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Follow up with the OPO to
obtain results of the drug
screen.
It would be prudent to
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Notify the recipient’s physician
 Follow the patient for
seroconversion
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Scenario # 1
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If the information was available before the
islets were infused, could the physician use
the product? Could he/she invoke Urgent
Medical Need?
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Use of the product depends on whether you
interpret the donor screening results as meeting the
Donor Eligibility criteria, and this depends on trying
to get more information before the product needs to
be released. While you have a report of drug
paraphernalia in the car, you don’t have any hard
evidence that the donor actually engaged in risk
behavior– so this is a very difficult judgment call.
Urgent medical need should only be invoked when
the patient has extremely limited clinical treatment
options and other products are not available.
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