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ACRP-CP CERTIFICATION EXAM NEWEST ACTUAL EXAM WITH COMPLETE QUESTIONS AND ANSWERS 2025/26, Exams of Clinical Medicine

ACRP-CP CERTIFICATION EXAM NEWEST ACTUAL EXAM WITH COMPLETE QUESTIONS AND ANSWERS |2025/2026 BRAND NEW!!!

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ACRP-CP CERTIFICATION EXAM NEWEST
ACTUAL EXAM WITH COMPLETE
QUESTIONS AND ANSWERS
|2025/2026 BRAND NEW!!!
Who is most responsible for the appropriate monitoring of
clinical trials? - ✔✔✔ Correct Answer > Sponsor
You are asked to monitor a study for another Coordinator. In
looking for the changes made in the source document you want
to see which of the following - ✔✔✔ Correct Answer > 1.
Unobscured original entries
2. Traceable source documents
3. An Audit trail
A Clinical Research Coordinator (CRC) adjusted the dose of the
Investigation Product (IP) for a subject as the subject was
suffering from Adverse Events (AEs) like headaches and
vomiting. When is a CRC allowed to do this task? - ✔✔✔
Correct Answer > Only when the CRC is a qualified physician
and has been delegated this responsibility by the PI
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Download ACRP-CP CERTIFICATION EXAM NEWEST ACTUAL EXAM WITH COMPLETE QUESTIONS AND ANSWERS 2025/26 and more Exams Clinical Medicine in PDF only on Docsity!

ACRP-CP CERTIFICATION EXAM NEWEST

ACTUAL EXAM WITH COMPLETE

QUESTIONS AND ANSWERS

| 202 5/2026 BRAND NEW!!!

Who is most responsible for the appropriate monitoring of

clinical trials? - ✔✔✔ Correct Answer > Sponsor

You are asked to monitor a study for another Coordinator. In looking for the changes made in the source document you want

to see which of the following - ✔✔✔ Correct Answer > 1.

Unobscured original entries

  1. Traceable source documents
  2. An Audit trail A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject as the subject was suffering from Adverse Events (AEs) like headaches and

vomiting. When is a CRC allowed to do this task? - ✔✔✔

Correct Answer > Only when the CRC is a qualified physician and has been delegated this responsibility by the PI

You are in the role of Study Manager for the Sponsor. One of your monitors reports significant noncompliance at a Site. The first course of action you implement is that a be

conducted. - ✔✔✔ Correct Answer > Root Cause Analysis

A subject: who has been 100% compliant thus far has forgotten to bring her medication back to the clinic for her regular visit. She reports that she has not missed any doses and has been fully compliant with the protocol. What is the most appropriate action for the investigator/clinical research coordinator to

take? - ✔✔✔ Correct Answer > Document that the subject has

forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or during her next visit If sponsor's attempts to secure compliance have failed: and the monitoring/auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution: the

sponsor should - ✔✔✔ Correct Answer > 1. Promptly notify the

regulatory authority(ies)

  1. Terminate the investigator's/institution's participation in the trial

Per ICH GCP E6: the purpose/elements of trial monitoring differ

from trial auditing. Which apply to trial auditing ONLY? - ✔✔✔

Correct Answer > 1. The sponsor should appoint individuals: who are independent of the clinical trials/systems

  1. 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?" - ✔✔✔ Correct Answer > 1.

Members of the armed forces

  1. Junior members of the medical profession
  2. Employees of the pharmaceutical industry Which phase determines therapeutic benefit: usually in wider

populations? - ✔✔✔ Correct Answer > Phase 3

What phase of a clinical trial involves a heavy emphasis on safety and tolerability: Pharmacokinetics: Pharmacodynamics

and early measurement of drug activity? - ✔✔✔ Correct

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 -

✔✔✔ Correct 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. - ✔✔✔ Correct Answer > 1. Selection of the

initial human dose

  1. Safe duration of drug exposure
  2. 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. - ✔✔✔ Correct Answer > True

  1. Clinical safety studies
  2. Studies of mortality/morbidity outcomes
  3. 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? - ✔✔✔ Correct Answer > 1. Food effects on

bioavailability

  1. Information in sub-populations such as patients with impaired elimination
  2. 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 - ✔✔✔ Correct 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 - ✔✔✔ Correct 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 - ✔✔✔ Correct 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? - ✔✔✔ Correct 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)? - ✔✔✔ Correct Answer >

True What is the purpose of the "Data and Safety Monitoring Board

(DSMB)?" - ✔✔✔ Correct Answer > 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. - ✔✔✔ Correct Answer > True

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? - ✔✔✔ Correct Answer > 1. Single-Blind

  1. Masking
  2. Double-Blind 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 - ✔✔✔ Correct Answer >

Generalization 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? - ✔✔✔ Correct Answer >

Confirmatory Trial You are designing a cross-over study. Cross-over designs have a number of problems that can invalidate their results. The chief difficulty concerns : that is: the residual influence

of treatments in subsequent treatment periods. - ✔✔✔ Correct

Answer > Carryover effect Missing data points (values) represent a potential source of bias

in a clinical trial. (True or False) - ✔✔✔ Correct Answer > True

What study variable takes in the consideration the decision making process of the treating physician: who must weigh

benefit and risk in making product use decisions. - ✔✔✔

Correct Answer > Global Assessment Variable True or False- You are working on a Phase 1 clinical trial. The sponsor tells you that the study will be carried out in three different research centers. Multi-center trials can be carried out

at any stage of clinical development. - ✔✔✔ Correct Answer >

True You are helping your Investigator write a protocol for a new combination of drugs for treatment of Irritable Bowel Syndrome. Since this is an Investigator Initiated Study you know

you will need to establish a/an - ✔✔✔ Correct Answer >

Independent Data Monitoring Committee

T or F- Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric

subjects. - ✔✔✔ Correct Answer > False

T or F- Pharmacokinetic studies in the pediatric population are

generally conducted in patients with the disease. - ✔✔✔

Correct Answer > True The two ways to minimize the number of samples obtained

from each pediatric patient are - ✔✔✔ Correct Answer > 1.

Population PK & Sparse sampling

  1. Use of indwelling catheters T or F- It is common to extrapolate efficacy from studies in adults or even in older pediatric patients to the preterm

newborn infant to decrease the amount of blood taken. - ✔✔✔

Correct Answer > False The current protocol for a study in pediatrics is asking for all new patients to have stages of pubertal development assessed.

This assessment is called - ✔✔✔ Correct Answer > Tanner

Staging

You are reading a Phase 2 protocol: which uses pharmacokinetic sampling in a pediatric population with Sickle Cell Disease. Which of the following options may be true in this

scenario? - ✔✔✔ Correct Answer > 1. The data may better

reflect clinical use

  1. This may lead to higher inter subject variability Dosing recommendations for most medicinal products used in the pediatric population are usually based on due to frequency of calculation errors. -

✔✔✔ Correct Answer > Mg/kg body weight

You are evaluating a pediatric protocol for a new drug. When reviewing the drug clearance data it is important to know that hepatic and renal functions are first mature in which of the

following defined group? - ✔✔✔ Correct Answer > Children

Non-compliance is a special problem in this age group. - ✔✔✔

Correct Answer > Adolescents The pediatric population represents a vulnerable subgroup. Therefore: special measures are needed to protect the rights of

When subjects are randomized to 1 of 2 or more arms: each arm being allocated a different treatment. Each treatment will include their investigational product at one or more doses: and one or more control treatments: such as placebo and/or an

active comparator - ✔✔✔ Correct Answer > Parallel

A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study

design they will use to test the efficacy of the IP? - ✔✔✔

Correct Answer > Non-Inferiority What type of clinical trial most likely requires enrollment of the

largest number of research subjects? - ✔✔✔ Correct Answer >

Therapeutic confirmatory (aka Pivotal Trial: Ph III: or Comparative Efficacy)

Minimum number of membors on an IRB/IEC - ✔✔✔ Correct

Answer > 5 (... lay people and medical professionals can be part of the IRB/IEC)

Who is responsible for providing the protocol - ✔✔✔ Correct

Answer > The Sponsor

The purpose of the SIV is to - ✔✔✔ Correct Answer > 1. review

standard procedures

  1. review the protocol
  2. review the blank eCRFs: Minimum SAE reporting requirements
  3. Subject details (ID not name)
  4. IP
  5. Interventions for the event that is being reported
  6. Details of the event
  7. Details on the reporter of the event
  8. Admin and sponsor or company details

Vulnerable subjects - ✔✔✔ Correct Answer > 1. Junior

members of the medical profession

  1. Employees of a pharmaceutical company
  2. Military personnel
  3. Pregnant Women
  4. Prisoners
  1. If the reaction is possibly: probably: or definitely related to the drug: it is considered an ADR
  2. All ADRs must be documented
  3. ADRs are not always AEs Not observed before. Or the Event occurred more often than

previously observed - ✔✔✔ Correct Answer > Unexpected

Event

Adverse Event (AE) - ✔✔✔ Correct Answer > 1. Any untoward

medical occurrence that does not necessarily have a causal relationship with treatment

  1. Can be mild moderate or severe
  2. Worsening of a pre-existing medical condition is an AE

Non-Clinical Study - ✔✔✔ Correct Answer > 1. Not conducted

on human subjects

  1. Provide preliminary safety and pharmacokinetic data needed to support studies in human

Data Safety and Monitoring Board (DSMB) - ✔✔✔ Correct

Answer > 1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints

  1. Can recommend that sponsors modify: end: or continue a trial. But cannot recommend they start a new trial

WMA - ✔✔✔ Correct Answer > World Medical Association

Declaration of Helsinki - ✔✔✔ Correct Answer > - Created by

WMA in 1964: - Defines the ethical principles for medical research involving human subjects

  1. Importance of ICF Requirement of ethical review and approval of research before it is undertaken:
  2. Acknowledgement and guidance of special protections for vulnerable subjects:
  3. Recommends trials are registered on public database

LAR - ✔✔✔ Correct Answer > Legally Acceptable

Representative. (regarding consenting procedures)

International Conference on Harmonization (ICH) - ✔✔✔

Correct Answer > Mission is to provide a unified standard for