- Joined
- Aug 14, 2014
- Messages
- 48
- Reaction score
- 5
Following GMPs helps ensure a products quality but not purity characteristics.
a. True
b. False
The goal of GCPs is to
a. Assure the rights, safety and welfare of subjects is provided
b. Assure the quality of data in clinical research
c. Assure the integrity of data in clinical research
d. All of the above
e. None of the above
The Declaration of Helsinki was prompted by the World War II Nazi Tragedies.
a. True
b. False
The Declaration of Helsinki was adopted in 1964 and is founding factor in GMP regulations.
a. True
b. False
21 CFR Part 210 is one of two sections of the regulation pertaining to GMPs.
a. True
b. False
CROs are
a. an entity that must comply with Good Clinical Practices
b. a delegate of an investigator
c. the entity submitting research to the FDA
d. Contract Research Organizations
e. Central Research Organizations
GMPs only apply to new drugs
a. True
b. False
Select all that apply to GCPs
a. 21 CFR Part 50
b. 21 CFR Part 210
c. 21 CFR Part 54
d. 21 CFR Part 11
e. None of the above
The following regulation(s) are Good Clinical Practices
a. 21 CFR Part 50
b. 21 CFR Part 10
c. 21 CFR Part 6
d. All of the above
e. None of the above
A serious adverse drug experience is the same thing as a life threatening adverse event.
a. True
b. False
a. True
b. False
The goal of GCPs is to
a. Assure the rights, safety and welfare of subjects is provided
b. Assure the quality of data in clinical research
c. Assure the integrity of data in clinical research
d. All of the above
e. None of the above
The Declaration of Helsinki was prompted by the World War II Nazi Tragedies.
a. True
b. False
The Declaration of Helsinki was adopted in 1964 and is founding factor in GMP regulations.
a. True
b. False
21 CFR Part 210 is one of two sections of the regulation pertaining to GMPs.
a. True
b. False
CROs are
a. an entity that must comply with Good Clinical Practices
b. a delegate of an investigator
c. the entity submitting research to the FDA
d. Contract Research Organizations
e. Central Research Organizations
GMPs only apply to new drugs
a. True
b. False
Select all that apply to GCPs
a. 21 CFR Part 50
b. 21 CFR Part 210
c. 21 CFR Part 54
d. 21 CFR Part 11
e. None of the above
The following regulation(s) are Good Clinical Practices
a. 21 CFR Part 50
b. 21 CFR Part 10
c. 21 CFR Part 6
d. All of the above
e. None of the above
A serious adverse drug experience is the same thing as a life threatening adverse event.
a. True
b. False
