ACRP CCRC Exam (NEW 2024/ 2025
Update) Questions and Verified Answers|
100% Correct| Graded A
QUESTION
The ethical principles underlying clinical study management are stated in a) Declaration of
Helsinki
b) Belmont report
c) Nuremberg Code
d) CIOMS guidelines
Answer:
a) Declaration of Helsinki
QUESTION
The term non-clinical studies refers to a) Studies in vitro cell culture models
b) Studies in organ culture c) Studies in animal models
d) Pilot human studies
Answer:
c) Studies in animal models
QUESTION
Nonclinical studies
a) Should be performed in at least three species b) Must include a disease animal model
c) Should be sufficient to indicate safety in human studies
d) Are not needed before some human studies
Answer:
c) Should be sufficient to indicate safety in human studies
QUESTION
Toxicology studies in animal models
a) Should be reviewed by qualified experts
b) Assessed for their implications of subject safety c) a only
d) a and b
,Answer:
d) a and b
QUESTION
Clinical trial protocols should reflect a) Reasonable costs for the clinical trial b) Minimize
sample sizes to reduce risks c) Sound scientific design
d) The use of control groups whenever possible
Answer:
c) Sound scientific design
QUESTION
The responsibility for the protection of clinical trial subjects rests with a) IRB/IEC
b) Investigator c) Sponsor
d) All of the above
Answer:
d) All of the above
QUESTION
ICH defined Human pharmacology trial are a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
a) Phase I
QUESTION
ICH defined Therapeutic Exploratory studies are likely to be a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
,b) Phase II
QUESTION
ICH defined Therapeutic Confirmatory studies are likely to be a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
c) Phase III
QUESTION
ICH defined Therapeutic Use studies are likely to be a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
d) Phase IV
QUESTION
Studies which examine dose tolerance, PK and PD aspects of a drug are likely to be
a) Human Pharmacology
b) Therapeutic Exploratory c) Therapeutic Confirmatory
d) Therapeutic use
Answer:
a) Human Pharmacology
QUESTION
Characterization of drug's absorption, metabolism and excretion a) Are confined to Phase I
studies
b) Can be conducted in Phase II studies if Phase I studies are inconclusive c) Are never studied in
Phase Ill studies
d) Continue throughout the development plan
Answer:
d) Continue throughout the devel- opment plan
, QUESTION
Studies which provide the most information for confirmatory study design are part of
a) Phase I studies b) Phase II studies c) a only
d) b only
Answer:
d) b only
QUESTION
Trials of short duration in narrow patient populations using pharmacolog- ical endpoints or
clinical measures are likely to be
a) Phase I b) Phase II c) Phase III
d) Phase IV
Answer:
b) Phase II
QUESTION
Studies which provide the most information for risk benefit relationship of a drug are likely to
be
a) Phase I b) Phase II c) Phase III
d) Phase IV
Answer:
c) Phase III
QUESTION
Studies on which marketing approval hinges are likely to be a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
d) Phase IV
Update) Questions and Verified Answers|
100% Correct| Graded A
QUESTION
The ethical principles underlying clinical study management are stated in a) Declaration of
Helsinki
b) Belmont report
c) Nuremberg Code
d) CIOMS guidelines
Answer:
a) Declaration of Helsinki
QUESTION
The term non-clinical studies refers to a) Studies in vitro cell culture models
b) Studies in organ culture c) Studies in animal models
d) Pilot human studies
Answer:
c) Studies in animal models
QUESTION
Nonclinical studies
a) Should be performed in at least three species b) Must include a disease animal model
c) Should be sufficient to indicate safety in human studies
d) Are not needed before some human studies
Answer:
c) Should be sufficient to indicate safety in human studies
QUESTION
Toxicology studies in animal models
a) Should be reviewed by qualified experts
b) Assessed for their implications of subject safety c) a only
d) a and b
,Answer:
d) a and b
QUESTION
Clinical trial protocols should reflect a) Reasonable costs for the clinical trial b) Minimize
sample sizes to reduce risks c) Sound scientific design
d) The use of control groups whenever possible
Answer:
c) Sound scientific design
QUESTION
The responsibility for the protection of clinical trial subjects rests with a) IRB/IEC
b) Investigator c) Sponsor
d) All of the above
Answer:
d) All of the above
QUESTION
ICH defined Human pharmacology trial are a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
a) Phase I
QUESTION
ICH defined Therapeutic Exploratory studies are likely to be a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
,b) Phase II
QUESTION
ICH defined Therapeutic Confirmatory studies are likely to be a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
c) Phase III
QUESTION
ICH defined Therapeutic Use studies are likely to be a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
d) Phase IV
QUESTION
Studies which examine dose tolerance, PK and PD aspects of a drug are likely to be
a) Human Pharmacology
b) Therapeutic Exploratory c) Therapeutic Confirmatory
d) Therapeutic use
Answer:
a) Human Pharmacology
QUESTION
Characterization of drug's absorption, metabolism and excretion a) Are confined to Phase I
studies
b) Can be conducted in Phase II studies if Phase I studies are inconclusive c) Are never studied in
Phase Ill studies
d) Continue throughout the development plan
Answer:
d) Continue throughout the devel- opment plan
, QUESTION
Studies which provide the most information for confirmatory study design are part of
a) Phase I studies b) Phase II studies c) a only
d) b only
Answer:
d) b only
QUESTION
Trials of short duration in narrow patient populations using pharmacolog- ical endpoints or
clinical measures are likely to be
a) Phase I b) Phase II c) Phase III
d) Phase IV
Answer:
b) Phase II
QUESTION
Studies which provide the most information for risk benefit relationship of a drug are likely to
be
a) Phase I b) Phase II c) Phase III
d) Phase IV
Answer:
c) Phase III
QUESTION
Studies on which marketing approval hinges are likely to be a) Phase I
b) Phase II
c) Phase III
d) Phase IV
Answer:
d) Phase IV
