ACRP CP CERTIFICATION - EXAMINATION COMPLETE QUESTIONS AND DETAILED SOLUTIONS LATEST UPDATE THIS YEAR JUST RELEASED

ACRP CP CERTIFICATION - EXAMINATION
COMPLETE QUESTIONS AND DETAILED SOLUTIONS
LATEST UPDATE THIS YEAR JUST RELEASED



Question 1: 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


Question 2: 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


Question 3: A trial where the treatment assignment is not known by
the study participant because of the use of placebo or other
methods of masking the intervention: but the study team knows
Answer:

Single blind

,Question 4: 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


Question 5: Per ICH E8: methods used to evaluate patient usage of
the test drug should be
Answer:

Specified in the protocol and actual usage documented


Question 6: Which trial design is used for the specific purpose of
examining the interaction of A and B?
Answer:

Factorial design


Question 7: 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


Question 8: What is the purpose of the "Data and Safety Monitoring
Board (DSMB)?"
Answer:

,To assess the progress of a clinical trial: the safety data: and the critical efficacy
endpoints


Question 9: T or F- The focus of ICH E9 is on statistical principles:
however: it does not address the use of specific statistical
procedures or methods.
Answer:

True


Question 10: For a randomized trial: the following is true
Answer:

1. The procedure to be followed: the necessary documentation: and the
subsequent treatment and assessment of the subject should all be described in
the protocol
2. Helps to avoid possible bias in the selection and allocation of subjects arising
from the predictability of treatment assignments


Question 11: Data and Safety Monitoring Boards (DSMBs) have the
power to recommend which of the following?
Answer:

1. That the sponsor should continue the trial
2.That the sponsor should modify the trial
3. That the sponsor should stop the trial


Question 12: You need to maintain the blind in a clinical study.
Which of the following options might you use when administering
supplies in the clinical trial?
Answer:

, Double-dummy


Question 13: Which variable in a study should be used to determine
the sample size?
Answer:

Primary variable


Question 14: You are writing an Investigator-initiated clinical
research protocol and you need to limit the occurrence of
conscious and unconscious bias. Which of the following methods
may be used?
Answer:

1. Single-Blind
2. Masking
3. Double-Blind


Question 15: You are reading the findings of a clinical trial on hair
loss and use of shampoo. You note in the final analysis that data
was extrapolated from the subjects who participated in the trial to a
broader patient population and a broader range of clinical settings.
This is known as
Answer:

Generalization


Question 16: The Investigator at your site asked you to review a
protocol. The investigational product listed in the protocol already
has proven clinical benefits for the disease under study. This is
considered what type of trial?
Answer: