The clinical investigator will update the financial disclosure information if any relevant
changes occur during
the investigation's course and for _______ following the study's completion.
A) 6 months
B) 1 year
C) 2 years
D) 5 years
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, B) 1 Year
True or False:
An IND is always required before using an investigational new drug.
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False
Explanation: Allows for emergency use; 21 CFR 312.36
True or False:
Per 21 CFR Part 312, the sponsor must notify FDA and all participating investigators in
an IND safety report within 15 calendar days after the sponsor determines that the
information qualifies for reporting.
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True
Explanation: 21 CFR 312.32(c)(1)
The 3 fundamental ethical principles for human subjects' in research are:
A) Respect for persons, beneficence, justice
B) Respect for subjects, their safety and their time
, C) Respect for sponsor, IRB and FDA guidelines
D) Respect for data, welfare and discovery
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A) Respect for persons, beneficence, justice
Each IRB that reviews studies involving children as subjects is covered by:
A) 21CFR Part 56, Sub part A
B) 21CFR Part 56, Sub part B
C) 21CFR Part 50, Sub part C
D) 21CFR Part 56, Sub part D
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D) 21CFR Part 56, Sub part D
In accordance with regulations, before implementation, the informed consent
document must be approved by the:
A) Sponsor
B) Investigator
C) IRB or IEC
D) A, B & C
E) B & C only
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C) IRB or IEC
changes occur during
the investigation's course and for _______ following the study's completion.
A) 6 months
B) 1 year
C) 2 years
D) 5 years
Give this one a try later!
, B) 1 Year
True or False:
An IND is always required before using an investigational new drug.
Give this one a try later!
False
Explanation: Allows for emergency use; 21 CFR 312.36
True or False:
Per 21 CFR Part 312, the sponsor must notify FDA and all participating investigators in
an IND safety report within 15 calendar days after the sponsor determines that the
information qualifies for reporting.
Give this one a try later!
True
Explanation: 21 CFR 312.32(c)(1)
The 3 fundamental ethical principles for human subjects' in research are:
A) Respect for persons, beneficence, justice
B) Respect for subjects, their safety and their time
, C) Respect for sponsor, IRB and FDA guidelines
D) Respect for data, welfare and discovery
Give this one a try later!
A) Respect for persons, beneficence, justice
Each IRB that reviews studies involving children as subjects is covered by:
A) 21CFR Part 56, Sub part A
B) 21CFR Part 56, Sub part B
C) 21CFR Part 50, Sub part C
D) 21CFR Part 56, Sub part D
Give this one a try later!
D) 21CFR Part 56, Sub part D
In accordance with regulations, before implementation, the informed consent
document must be approved by the:
A) Sponsor
B) Investigator
C) IRB or IEC
D) A, B & C
E) B & C only
Give this one a try later!
C) IRB or IEC
