ACRP-CP 시험 - ACRP실제시험문제와 답 - 125문항

Question No : 1

A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the 1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP.
What is the participant’s overall compliance?

A.66%
B.71%
C.77%
D.80%

정답:
Explanation:
Step 1: Calculate the total number of tablets dispensed:
Month 1: 35 tablets
Month 2: 35 tablets
Total: 70 tablets
Step 2: Calculate the number of tablets returned:
Month 1: 10 tablets
Month 2: 12 tablets
Total: 22 tablets
Step 3: Calculate the number of tablets taken:
70 - 22 = 48 tablets
Step 4: Calculate compliance:
Compliance = (Tablets Taken / Total Tablets) × 100
Compliance = (48 / 62) × 100 # 77%
GCP guidelines require accurate calculation of compliance based on returned IP counts, ensuring proper dose administration monitoring.
"Compliance rates are calculated by comparing the number of tablets taken to the total number of tablets dispensed, considering the returned count."

Question No : 2

An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results.
Who should perform a root cause analysis and implement appropriate corrective and preventive actions?

A.Sponsor
B.PI
C.IRB/IEC
D.DSMB/IDMC

정답:
Explanation:
The Principal Investigator (PI) is responsible for conducting a root cause analysis when non-compliance is identified at the site. The PI must identify the reasons for non-compliance and develop a Corrective and Preventive Action (CAPA) plan to address and prevent future occurrences.
This answer aligns with GCP principles that designate the PI as responsible for site-level compliance and corrective actions.
"The PI must take responsibility for investigating the cause of non-compliance and developing a CAPA plan to mitigate recurrence."

Question No : 3

Who takes responsibility for initiating a clinical trial?

A.CRO
B.Investigator
C.IRB/IEC
D.Sponsor

정답:
Explanation:
The sponsor is responsible for initiating a clinical trial. This involves developing the protocol, securing funding, selecting study sites, and obtaining regulatory approvals. The sponsor also oversees the conduct of the trial to ensure compliance with GCP and regulatory requirements.
According to GCP guidelines, the sponsor is the entity that initiates, manages, and finances the clinical investigation.
"The sponsor is responsible for initiating, managing, and financing the clinical trial, including protocol development and site selection."

Question No : 4

A sponsor wants to transfer duties to a CRO.
Which of the following statements is the MOST correct?

A.The IRB/IEC must approve the transfer of duties to a CR
B.All duties transferred to a CRO should be specified in writing.
C.Any trial-related duties can be documented as transferred by verbal agreement.
D.Regulatory authorities must be notified promptly of the transfer of any duties to a CR

정답:
Explanation:
When a sponsor transfers specific tasks to a Contract Research Organization (CRO), it must be documented in writing. This formal documentation clearly delineates responsibilities and ensures that both parties are aware of their roles and obligations. Verbal agreements are not sufficient for regulatory compliance.
ICH E6(R2) GCP guidelines mandate that all delegated tasks must be documented formally to ensure clarity and compliance.
"The sponsor should document in writing any responsibilities transferred to a CRO to ensure clear delineation of roles."

Question No : 5

Who ensures information regarding payments to subjects is documented in a written consent form?

A.Coordinator
B.IRB/IEC
C.PI
D.Sponsor

정답:
Explanation:
The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.
The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consent forms, including payment details.
"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants."

Question No : 6

Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

A.CRA
B.CRO
C.Sponsor
D.Data Manager

정답:
Explanation:
The sponsor is responsible for establishing written procedures to ensure that all changes or corrections in Case Report Forms (CRFs) are properly documented and justified. These procedures must include who is authorized to make changes, how corrections are documented, and how they are endorsed by the investigator. This practice ensures data accuracy and traceability.
GCP guidelines indicate that sponsors must establish and maintain procedures for data handling and documentation to ensure accuracy and reliability.
"The sponsor should develop written procedures to ensure that CRF changes are justified, documented, and endorsed by the investigator."

Question No : 7

A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

A.A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
B.A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
C.A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
D.A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population

정답:
Explanation:
Since both the investigator and the participant are unaware of the treatment assignment, the study is classified as double-blind. The study aims to establish the superiority of XYZ over ABC, making it a superiority study. The use of masked IV bags confirms the double-blind design.
The answer is verified from GCP guidelines on blinding and superiority study designs.
"In double-blind studies, neither the participant nor the investigator knows the treatment assignment, which prevents bias."

Question No : 8

An impartial witness should be present during the entire informed consent discussion when:

A.A subject has been determined to be vulnerable.
B.A parent/guardian is consenting for a minor subject.
C.A legally acceptable representative is unable to read.
D.An interpreter is translating the consent form for a subject.

정답:
Explanation:
An impartial witness is required when a legally acceptable representative (LAR) or the subject themselves cannot read. The witness ensures that the information is presented accurately and that the consent process is conducted ethically. The witness also signs the consent form to confirm that the subject or representative understands the study details.
GCP guidelines require an impartial witness to be present to confirm that the consent information is correctly conveyed and understood when the subject or LAR cannot read.
"An impartial witness is required when the subject or legally acceptable representative is unable to read, ensuring the consent process is transparent and ethically sound."

Question No : 9

Which of the following elements of the Informed Consent are NOT required?

A.A description of any reasonably foreseeable risks or discomforts
B.Statement that study involves research
C.A description of potential benefits
D.Subject legal rights can be waived

정답:
Explanation:
Informed consent must not include any language that implies a waiver of the participant’s legal rights or releases the investigator, sponsor, or institution from liability for negligence. Such language violates ethical standards and the principles of voluntary participation.
According to GCP guidelines and ethical principles, the informed consent document must not include any clause that waives a participant's legal rights.
"An informed consent form must not include language that waives the participant’s legal rights or releases the sponsor or investigator from liability."

Question No : 10

A root cause analysis should be:
A. Specific to a clinical trial.
B. Written by the investigator.
C. Validated before use in a CAPA.
D. Focused on issues of non-compliance.

정답: D
Explanation:
Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non-compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non-compliance ensures that the study adheres to GCP and regulatory requirements.
GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.
"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively."

Question No : 11

The sponsor should supply a PI with the IP after:

A.Approval of protocol by the sponsor.
B.Approval/favorable opinion from IRB/IEC and regulatory authority.
C.Submission of documents to IRB/IEC and regulatory authority for review.
D.Approval of protocol by the P

정답:
Explanation:
The sponsor may only provide the investigational product (IP) after the IRB/IEC and relevant regulatory authorities have approved the protocol. This ensures that the trial complies with ethical and legal standards before initiating IP administration.
According to GCP guidelines, sponsors must wait for all necessary approvals before distributing IP to the trial site.
"The investigational product may only be supplied after obtaining regulatory and IRB/IEC approval to ensure ethical conduct of the trial."

Question No : 12

An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects.
What are the NEXT steps the investigator should take?

A.Add the risk of infection to the ICF and submit to the IRB/IEC for review.
B.Update the IB to add the risk of infection and submit to the sponsor for approval.
C.Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
D.Discontinue current subjects from the study and monitor subjects for any anticipated safety events.

정답:
Explanation:
The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.
GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.
"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection."

Question No : 13

The investigator/institution should permit:

A.Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
B.Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
C.Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
D.Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

정답:
Explanation:
The investigator and institution must allow both monitoring and inspection by the appropriate regulatory authorities and auditing by the sponsor. This dual oversight ensures that the trial complies with regulatory standards and sponsor requirements, thereby maintaining the integrity and validity of the data.
GCP guidelines specify that regulatory authorities have the right to inspect, while sponsors typically conduct audits to verify compliance and data quality.
"The institution should permit monitoring and inspection by regulatory authorities and auditing by the sponsor to ensure compliance with GCP and protocol adherence."

Question No : 14

A serious unexpected ADR is one:

A.Severity and nature of the reaction is consistent with protocol.
B.Where the severity of the reaction is not consistent with I
C.That does not need to be reported to the IRB/IE
D.That results in the death of the subject.

정답:
Explanation:
A serious unexpected adverse drug reaction (ADR) is characterized by an event that is not consistent with the information provided in the Investigator’s Brochure (IB). Such reactions may indicate new risks associated with the investigational product and warrant immediate reporting to the sponsor and regulatory authorities.
This answer follows the ICH E6(R2) GCP guidelines, which specify the criteria for reporting serious and unexpected adverse events.
"An unexpected adverse drug reaction is one whose nature or severity is not consistent with the applicable product information (e.g., IB)."

Question No : 15

All of the following are examples of what monitors review EXCEPT:

A.Regulatory binder which includes copies of current certifications for all laboratories.
B.The signed ICF retained in the participant's study file.
C.Potential patient medical records for eligibility prior to the informed consent process.
D.Documentation in the participant's medical record of study drug administration.

정답:
Explanation:
Monitors are responsible for reviewing documents that pertain to study conduct and data integrity, including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration. However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.
According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.
"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations."

ACRP ACRP-CP 시험