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ACRP-CP CERTIFICATION EXAM WITH ACTUAL CORRECT QUESTIONS AND VERIFIED DETAILED ANSWERS |FREQUENTLY TESTED QUESTIONS AND SOLUTIONS |ALREADY GRADED A+|NEWEST|GUARANTEED PASS |LATEST UPDATE$20.49
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ACRP-CP CERTIFICATION EXAM 2024-
2025 WITH ACTUAL CORRECT
QUESTIONS AND VERIFIED DETAILED
ANSWERS |FREQUENTLY TESTED
QUESTIONS AND SOLUTIONS |ALREADY
GRADED A+|NEWEST|GUARANTEED
PASS |LATEST UPDATE
What is the purpose of the IRB/IEC?
Safeguard the rights: safety: and well-being of all trial subjects
Which of the following should the investigator do FIRST if a Serious Adverse Event (SAE) occurs?
Inform the Sponsor per protocol and regulatory requirements
According to ICH E6 Who must sign the Informed Consent Form (ICF)?
1. The person who conducted the informed consent interview
2. The subject or the subject's legal representative
A non-English speaking subject has responded to a recruitment ad to participate in a trial for treatment
of her diabetes. She arrives at the site with her daughter who is fluent in English. The informed consent
forms are only available in English. What actions are compliant with GCP?
Call the sponsor to request a translation of the informed consent
Per ICH GCP E6: the purpose/elements of trial monitoring differ from trial auditing. Which apply to trial
auditing ONLY?
1. The sponsor should appoint individuals: who are independent of the clinical trials/systems
2. Regulatory authority(ies) should not routinely request this type of reports*
*(they may seek access to reports on a case by case basis when evidence of serious GCP non-compliance
exists: or in the course of legal proceedings)
As per ICH E6 GCP: which groups of potential subjects could be defined as "vulnerable subjects?"
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,1. Members of the armed forces
2. Junior members of the medical profession
3. Employees of the pharmaceutical industry
Which phase determines therapeutic benefit: usually in wider populations?
Phase 3
What phase of a clinical trial involves a heavy emphasis on safety and tolerability: Pharmacokinetics:
Pharmacodynamics and early measurement of drug activity?
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
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.
1. Selection of the initial human dose
2. Safe duration of drug exposure
3. Physiological and toxicological effects of a new drug
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.
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?
Phase One
Characterization of a drug's absorption: distribution: metabolism: and excretion that continues
throughout the development plan is defined as
Pharmacokinetics
According to ICH E8: "Formulations used in clinical trials should be well characterized: including
information on ___________ whenever feasible."
Bioavailability
The study subject asks you why the study is called a double blind study. You will explain double blind as
When the Investigator and sponsor staff who 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
Your Investigator wants to participate in a Phase 3 Pharmacokinetics study. Pharmacokinetic studies are
commonly conducted in later phases to answer what questions?
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 methods of masking the intervention: but the study team knows
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
Include children in the general plan from the beginning
Per ICH E8: methods used to evaluate patient usage of the test drug should be
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?
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)?
True
What is the purpose of the "Data and Safety Monitoring Board (DSMB)?"
To assess the progress of a clinical trial: the safety data: and the critical efficacy endpoints
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.
True
For a randomized trial: the following is true
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
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