What is the minimum number of Institutional Review board (IRB) members?
a. 3
b. 5
c. 6- ✔ Answer ✔ -b. 5
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new
dosage would be?
a. 91
b. 100
c. 77- ✔ Answer ✔ -c. 77
The responsibility for ensuring that the investigator understands a clinical trial lies with:
a. The FDA
b. The IRB
c. The Sponsor- ✔ Answer ✔ -c. The Sponsor
Significant risk device is defined as an investigational device that is:
a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a
subject.
b. Purported or represented to be for a use in supporting or sustaining human life and presents a
potential risk to the health, safety, or welfare of a subject.
a. 3
b. 5
c. 6- ✔ Answer ✔ -b. 5
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new
dosage would be?
a. 91
b. 100
c. 77- ✔ Answer ✔ -c. 77
The responsibility for ensuring that the investigator understands a clinical trial lies with:
a. The FDA
b. The IRB
c. The Sponsor- ✔ Answer ✔ -c. The Sponsor
Significant risk device is defined as an investigational device that is:
a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a
subject.
b. Purported or represented to be for a use in supporting or sustaining human life and presents a
potential risk to the health, safety, or welfare of a subject.
