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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
- Traceable source documents
- 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)
- 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
- 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
- Junior members of the medical profession
- 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
- Safe duration of drug exposure
- 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
- Clinical safety studies
- Studies of mortality/morbidity outcomes
- 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
- Information in sub-populations such as patients with impaired elimination
- 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
- Masking
- 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
- 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
- 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
- review the protocol
- review the blank eCRFs: Minimum SAE reporting requirements
- Subject details (ID not name)
- IP
- Interventions for the event that is being reported
- Details of the event
- Details on the reporter of the event
- Admin and sponsor or company details
Vulnerable subjects - ✔✔✔ Correct Answer > 1. Junior
members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
- If the reaction is possibly: probably: or definitely related to the drug: it is considered an ADR
- All ADRs must be documented
- 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
- Can be mild moderate or severe
- Worsening of a pre-existing medical condition is an AE
Non-Clinical Study - ✔✔✔ Correct Answer > 1. Not conducted
on human subjects
- 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
- 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
- Importance of ICF Requirement of ethical review and approval of research before it is undertaken:
- Acknowledgement and guidance of special protections for vulnerable subjects:
- 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
