CCRP SOCRA Exam - 21 CFR Part 812 with all Correct & 100%
Verified Answers |Latest Version |Already Graded A+
1. What does Title 21 CFR Part 812 cover? Investigational Device Exemptions
2. In 21 CFR Part 812, to what does b) Federal Food, Drug, and
"Act" re-fer? Cosmetic Act
a) clinical investigation or research
involv-ing one or more subjects
b) Federal Food, Drug, and Cosmetic
Act
c)discontinuance, by sponsor or by
with-drawal of IRB or FDA approval
3. In 21 CFR Part 812, to what does
b) device that is placed into a
"Implant" refer?
surgically or naturally formed cavity of
a) device, including a transitional the human body if it is intended to
device, that is the object of an remain there for a period of 30 days
investigation or more
b) device that is placed into a
surgically or naturally formed cavity
of the human body if it is intended to
remain there for a period of 30 days
or more
c)device FDA considered to be a new
drug or an antibiotic drug before
May 1976
4. In 21 CFR Part 812, to what does death or other
"Termina-tion" refer? permanently altered
physical or mental
a) clinical investigation or research state
involv-ing one or more subjects c)discontinuance, by
b) serious adverse effect resulting in sponsor or by with-
1/
12
, CCRP SOCRA Exam - 21 CFR Part 812 with all Correct & 100%
Verified Answers |Latest Version |Already Graded A+
c) discontinuance, by sponsor or by with-drawal of IRB or
FDA approval, of an inves-tigation before completion
2/
12
Verified Answers |Latest Version |Already Graded A+
1. What does Title 21 CFR Part 812 cover? Investigational Device Exemptions
2. In 21 CFR Part 812, to what does b) Federal Food, Drug, and
"Act" re-fer? Cosmetic Act
a) clinical investigation or research
involv-ing one or more subjects
b) Federal Food, Drug, and Cosmetic
Act
c)discontinuance, by sponsor or by
with-drawal of IRB or FDA approval
3. In 21 CFR Part 812, to what does
b) device that is placed into a
"Implant" refer?
surgically or naturally formed cavity of
a) device, including a transitional the human body if it is intended to
device, that is the object of an remain there for a period of 30 days
investigation or more
b) device that is placed into a
surgically or naturally formed cavity
of the human body if it is intended to
remain there for a period of 30 days
or more
c)device FDA considered to be a new
drug or an antibiotic drug before
May 1976
4. In 21 CFR Part 812, to what does death or other
"Termina-tion" refer? permanently altered
physical or mental
a) clinical investigation or research state
involv-ing one or more subjects c)discontinuance, by
b) serious adverse effect resulting in sponsor or by with-
1/
12
, CCRP SOCRA Exam - 21 CFR Part 812 with all Correct & 100%
Verified Answers |Latest Version |Already Graded A+
c) discontinuance, by sponsor or by with-drawal of IRB or
FDA approval, of an inves-tigation before completion
2/
12
