A sponsor shall retain the records and reports required by 21 CFR Part 312 for ____
year(s) after a marketing application is approved for the drug.
a) 1
b) 2
c) 5
d) indefinitely
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, b) 2
FDA may permit an investigational drug to be used for the treatment of an individual
patient by a licensed physician under the following criteria:
a) the physician must determine that the probable risk the person from the
investigational drug is not greater than the probable risk from the disease or
condition
b) the patient cannot obtain the drug under another IND or protocol
c)a and b
d) none of the above
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c)a and b
An expanded access IND goes into effect _____ days after FDA receives the protocol
or upon earlier notification by the FDA.
a) 90
b) 60
c) 30
d) 14
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c) 30
, An investigator's responsibilities under an expanded access includes the following:
a) reporting adverse drug events to the sponsor
b) informed consent requirements are met
c) IRB review is obtained
d) accurate case histories and drug disposition records are maintained
e) all of the above
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e) all of the above
True or False:
An expanded access submission must include Form FDA 1571
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True
A cover sheet (Form FDA 1571)
True or False:
Subject means a human who participates in an investigation, as a recipient of the
investigational new drug. A subject may be a healthy human or a patient with a
disease.
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year(s) after a marketing application is approved for the drug.
a) 1
b) 2
c) 5
d) indefinitely
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, b) 2
FDA may permit an investigational drug to be used for the treatment of an individual
patient by a licensed physician under the following criteria:
a) the physician must determine that the probable risk the person from the
investigational drug is not greater than the probable risk from the disease or
condition
b) the patient cannot obtain the drug under another IND or protocol
c)a and b
d) none of the above
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c)a and b
An expanded access IND goes into effect _____ days after FDA receives the protocol
or upon earlier notification by the FDA.
a) 90
b) 60
c) 30
d) 14
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c) 30
, An investigator's responsibilities under an expanded access includes the following:
a) reporting adverse drug events to the sponsor
b) informed consent requirements are met
c) IRB review is obtained
d) accurate case histories and drug disposition records are maintained
e) all of the above
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e) all of the above
True or False:
An expanded access submission must include Form FDA 1571
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True
A cover sheet (Form FDA 1571)
True or False:
Subject means a human who participates in an investigation, as a recipient of the
investigational new drug. A subject may be a healthy human or a patient with a
disease.
Give this one a try later!
