ACRP Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A
ACRP Exam (Latest 2024/ 2025 Update)
Questions and Verified Answers| 100%
Correct| Grade A
Q: To be a qualifying clinical trial, which three requirements must be met?
a. the trial has therapeutic intent, has an investigational new drug number, and enrolls patients
with diagnosed disease
b. the trial has therapeutic intent, enrolls patients with diagnosed disease and evaluates an
item/service that falls within a medicare benefit category
c. the trial has therapeutic intent, has an investigational new drug number, and does not evaluate
an item/service that falls within a medicare benefit category
d. the trial has an investigational new drug number, does not enroll patients with diagnosed
disease and evlauates an item/service that falls within a medicare benefit category
Answer:
b
Q: A process by which a subject voluntarily confirms his or her willingness to participate in a
particular trial, after having been informed of all aspects of the trial that are relevant to the
subject’s decision to participate is known as an:
a. assent
b. informed consent
c. subject agreement
d. dissent
Answer:
b
Q: The primary purpose of the IRB is to ensure
a. proper maintenance of the investigation
b. to ensure the protection of the rights and welfare of the human subjects
d. the information needed to conduct an investigation is valid
d. all protocol required procedures occur according to protocol-specified guidelines
Answer:
b
Q: The IRB has the ability to waive the informed consent requirement if the research is no more
than minimal risk and involves no procedures for which consent is required outside the research
context and in
a. emergency research
b. in vitro research
c. pre-clinical research
d. animal research
Answer:
a
Q: An investigational new drug application becomes effective _ days after receipt by the FDA (barring a hold, request for additional information, or rejection of an application); is valid one year; and must be updated within days of taking effect
a. 30, 60
b. 60, 30
c. 90, 90
d. 120, 60
Answer:
a
Q: Which phase of a trial primarily focuses on safety and effectiveness, is dose-ranging and
occurs in subjects with the disease or condition under study?
a. phase 1
b. phase 2
c. phase 3
d. phase 4
Answer:
b
Q: Quality documentation practices ALCOAC. What does this stand for?
Answer:
Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Q: After a new drug application is approved, the responsibility for reporting safety issues to the
FDA rests with
a. the irb
b. the sponsor
c. the principal investigator
d. the clinical research coordinator
Answer:
b
Q: To whom may a sponsor transfer its responsibility for any or all of its clinical trial
obligations?
a. clinical research associate
laboratory and other related vendors
c. contract research organization
d. site study manager
Answer:
c
Q: Which FDA center assures that patients and providers have t imely and continued access to
safe, effective, and high quality medical devices and safe radiation emitting products?
a. BIMO
b. CBER
c. CDER
d. CDRH
Answer:
d
Q: All noxious and unintended responses to a medicinal product related to any dose should be
considered an
a. adverse drug reaction
b. unanticipated adverse reaction
c. adverse event
d. uncomplicated drug reaction
Answer:
a
Q: The sponsor has how many days to report a non-fatal IND safety report to the FDA?
Answer:
15 calendar days
Q: What are examples of hidden costs in a study budget?
a. monthly rent payment
b. scheduled study visits
c. unexpected equipment failure
d. IRB submission fee
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Phase I The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers
Who is ultimately responsible for all aspects of the research conducted at a site? Principal investigator
Define GCP An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data
What event resulted in the Nuremburg Cod of 1949 Nazi Medical Experiments
Which ICH Guideline is known as the GCP guideline? E6(R2)
What are the basic ethical principles of the Belmont Report? Beneficence, Respect for persons, Justice
Define CBER, and full title Center for Biologics Evaluation and ResearchFDA center that regulates blood, vaccine, gene therapy and tissue
What is the International Conference on Harmonization (ICH) Guidelines? A unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in the European Union, Japan and United States.
To be a qualifying clinical trial, which three requirements must be met? Therapeutic Intent Enrolls patients with diagnosed disease Evaluates an item/service that falls within a Medicare Benefit Category
Define informed consent A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subjects decision to participate.
Primary purpose of IRB To ensure the protection of the rights and welfare of the human subjects
When can IRB waive informed consent? IRB has the ability to waive the informed consent requirement if the research is no more than minimal risk and involves no procedures for which consent is required outside of the research context and in emergency research
An investigational New Drug (IND) Application becomes effective _ days after receipt by the FDA (barring a hold, request for additional information, or rejection of an application); is valid one year; and must be updated within days of taking effect. 30, 60
Phase II Focuses primarily on safety and effectiveness, is dose-ranging and occurs in subjects with the disease or condition.
Quality documentation practices ALCOAC stands for Attributable, Legible, Contemporaneous, Original, Accurate, Complete
After the New Drug Application is approved, the responsibility for reporting safety issues to the FDA rests with The sponsor
To whom may a sponsor transfer its responsibility for any or all of its clinical trial obligations? Contract Research Organization
Define role of CDRH and abbreviation Center for Devices and Radiological HealthFDA center that assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
Define Adverse Drug reaction all noxious and unintended response to a medicinal product related to any dose.
How many days does a sponsor have to report non-fatal IND safety report to the FDA 15 calendar days
What are examples of hidden costs in a study budget Unexpected equipment failure
Four types of monitoring visits are: Qualification, Initiation, Routine, Close-out
Define Protocol A document that describes the objective(s), design, methodology, statistical considerations and organization of a trial.
Phase III Phase of trial that primarily focuses on confirming effectiveness and establishing a safety profile in subjects with the disease or condition and other concurrent illnesses and medications.
Case Report Forms (CRFs) are typically developed by the and the performs source document verification Sponsor, Monitor
Define BIMO and abbreviation Bioresearch Monitoring Program Information FDA center that ensures the protection of research subjects and the integrity of data submitted to the agency in support of a marketing application.
Define AE An untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causa relationship with this treatment.
Define UADE Unanticipated, adverse device effect. Must be serious, related and unexpected
Whom should the sponsor notify of findings that affect the safety of the subjects? All participating investigators and the regulatory authority
According to the ICH GCP, who is responsible for ensuring that clinical trial site staff is trained on the protocol, investigation product, and their trial-related duties, and functions The PI
What is the primary difference between an AE and an ADR(advanced drug reaction) An ADR is always related to the study drug and an AE may or may not be related to the study drug.
Define CDER and abbreviation Center for Drug Evaluation and ResearchFDA center responsible for regulating over-the-counter and prescription drugs, including generic drugs
At what frequency does an RIB need to conduct continuing review of each clinical trial? Intervals appropriate to the degree of risk to human subjects, but at least once per year.
The purpose of ___ is to document qualifications and eligibility to conduct a trial and/or provide medical supervision of subjects Curriculum vitae
What are the requirements for conducting a study in the USA A study conducted in the USA needs to be compliant with both ICH GCP guidelines and FDA regulations
What documentation does the monitor provide the investigator and site staff for a monitoring visit? Pre-visit letter, initiation monitoring report, post-visit letter.
Clinical Trial Any investigation in human subjectes intended to discover or veryf the clinical, pharmacological and or other pharmacodynamic effects of an IP or to identify adverse reactions to an IP, or absorption, distribution, metabolism and excretion of an IP.
Research An activity designed to test a hypothesis, permit conclusions to be drawn and, thereby, to develop or contribute to general knowledge.
Clinical practice intereventions that are designed solely to enhance the well-being of the individual and that have a reasonable expectation of success.
Patient-oriented research IND/IDEInvestment in new drug, biologics, ie vaccines. IND/ IDE: Invest Device Exemption
IND Investigational New Drug, any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. Any use of drug except for the marketed intention of the drug.
IDE Investigational Device Exemtpion: A clinical investigation or research involving the safety or effectiveness of a device.
General Responsibilities of Sponsors: 21 CFR 312.50-.59 Sponsors are responsible for selecting qualified investagors, providin gthem witht he information they need to conduct an investigation properly, ensuring proper monitoring of the investigations, ensuring that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND, maintianing an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed.
IEC Independent Ethics Committee (AKA IRB): An independent body constituted of medical professionals and non-medical member, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial
CFR Code of Federal Regulations: ——
ICH International Council for Harmonization E6(R2) = GCPNeed to standardize regulationsEurope, Japan, USSafety, quality, efficacy