1|Page
ACRP CP FINAL EXAM 2025/2026 ACRP CP
CERTIFICATION EXAM NEWEST 2025/ 2026
COMPLETE ALL 250 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+||GUARANTEED
PASS!!!|NEWEST EXAM!!!
What phase of a clinical trial involves a heavy emphasis
on safety and tolerability: Pharmacokinetics:
Pharmacodynamics and early measurement of drug
activity? - ANSWER-Phase 1
The principles and practices concerning protection of trial
subjects are stated in the ICH Guideline on Good Clinical
Practice (ICH E6). These principles have their origins from
- ANSWER-Declaration of Helsinki
The main goal of this phase of drug development is to
explore therapeutic efficacy in patients. It is important
during this phase to determine the dose(s) and regimens
that will be used for later trials. - ANSWER-1. Selection of
the initial human dose
2. Safe duration of drug exposure
3. Physiological and toxicological effects of a new drug
,2|Page
T or F- The intention of ICH E8 is to describe
internationally accepted principles and practices in the
conduct of both individual clinical trials and overall
development strategy for new medicinal products. -
ANSWER-True
Dose-tolerance studies: single and multiple dose PK
and/or PD studies: and drug interaction studies are
examples of what phase of clinical research? - ANSWER-
Phase One
Characterization of a drug's absorption: distribution:
metabolism: and excretion that continues throughout the
development plan is defined as - ANSWER-
Pharmacokinetics
According to ICH E8: "Formulations used in clinical trials
should be well characterized: including information on
___________ whenever feasible." - ANSWER-
Bioavailability
The study subject asks you why the study is called a
double blind study. You will explain double blind as -
ANSWER-When the Investigator and sponsor staff who
,3|Page
are involved in the treatment or clinical evaluation of the
subjects and analysis of data are unaware of the treatment
assignments
According to ICH E8 what type of study would have the
following elements? Adequate: and well controlled studies
to establish efficacy - ANSWER-1. Randomized parallel
dose response studies
2. Clinical safety studies
3. Studies of mortality/morbidity outcomes
4. Large simple trials
-Therapeutic Confirmatory
Your Investigator wants to participate in a Phase 3
Pharmacokinetics study. Pharmacokinetic studies are
commonly conducted in later phases to answer what
questions? - ANSWER-1. Food effects on bioavailability
2. Information in sub-populations such as patients with
impaired elimination
3. Drug to drug interactions
A trial where the treatment assignment is not known by the
study participant because of the use of placebo or other
, 4|Page
methods of masking the intervention: but the study team
knows - ANSWER-Single blind
A new study is investigating a new IND "glue" that can be
used to hold skin cuts together and decrease the chance
of scaring. You know children should be included because
ICH E8 considers them a special population. In designing
the protocol you should expect to - ANSWER-Include
children in the general plan from the beginning
Per ICH E8: methods used to evaluate patient usage of
the test drug should be - ANSWER-Specified in the
protocol and actual usage documented
Which trial design is used for the specific purpose of
examining the interaction of A and B? - ANSWER-Factorial
design
T or F- The Data and Safety Monitoring Board (DSMB) is a
separate entity from an Institutional Review Board (IRB) or
an Independent Ethics Committee (IEC)? - ANSWER-True
ACRP CP FINAL EXAM 2025/2026 ACRP CP
CERTIFICATION EXAM NEWEST 2025/ 2026
COMPLETE ALL 250 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+||GUARANTEED
PASS!!!|NEWEST EXAM!!!
What phase of a clinical trial involves a heavy emphasis
on safety and tolerability: Pharmacokinetics:
Pharmacodynamics and early measurement of drug
activity? - ANSWER-Phase 1
The principles and practices concerning protection of trial
subjects are stated in the ICH Guideline on Good Clinical
Practice (ICH E6). These principles have their origins from
- ANSWER-Declaration of Helsinki
The main goal of this phase of drug development is to
explore therapeutic efficacy in patients. It is important
during this phase to determine the dose(s) and regimens
that will be used for later trials. - ANSWER-1. Selection of
the initial human dose
2. Safe duration of drug exposure
3. Physiological and toxicological effects of a new drug
,2|Page
T or F- The intention of ICH E8 is to describe
internationally accepted principles and practices in the
conduct of both individual clinical trials and overall
development strategy for new medicinal products. -
ANSWER-True
Dose-tolerance studies: single and multiple dose PK
and/or PD studies: and drug interaction studies are
examples of what phase of clinical research? - ANSWER-
Phase One
Characterization of a drug's absorption: distribution:
metabolism: and excretion that continues throughout the
development plan is defined as - ANSWER-
Pharmacokinetics
According to ICH E8: "Formulations used in clinical trials
should be well characterized: including information on
___________ whenever feasible." - ANSWER-
Bioavailability
The study subject asks you why the study is called a
double blind study. You will explain double blind as -
ANSWER-When the Investigator and sponsor staff who
,3|Page
are involved in the treatment or clinical evaluation of the
subjects and analysis of data are unaware of the treatment
assignments
According to ICH E8 what type of study would have the
following elements? Adequate: and well controlled studies
to establish efficacy - ANSWER-1. Randomized parallel
dose response studies
2. Clinical safety studies
3. Studies of mortality/morbidity outcomes
4. Large simple trials
-Therapeutic Confirmatory
Your Investigator wants to participate in a Phase 3
Pharmacokinetics study. Pharmacokinetic studies are
commonly conducted in later phases to answer what
questions? - ANSWER-1. Food effects on bioavailability
2. Information in sub-populations such as patients with
impaired elimination
3. Drug to drug interactions
A trial where the treatment assignment is not known by the
study participant because of the use of placebo or other
, 4|Page
methods of masking the intervention: but the study team
knows - ANSWER-Single blind
A new study is investigating a new IND "glue" that can be
used to hold skin cuts together and decrease the chance
of scaring. You know children should be included because
ICH E8 considers them a special population. In designing
the protocol you should expect to - ANSWER-Include
children in the general plan from the beginning
Per ICH E8: methods used to evaluate patient usage of
the test drug should be - ANSWER-Specified in the
protocol and actual usage documented
Which trial design is used for the specific purpose of
examining the interaction of A and B? - ANSWER-Factorial
design
T or F- The Data and Safety Monitoring Board (DSMB) is a
separate entity from an Institutional Review Board (IRB) or
an Independent Ethics Committee (IEC)? - ANSWER-True
