ACRP ACRP-CP試験問題（更新されたのは2025年）100%リアル問題解答
合格させるACRP ACRP-CP試験最速合格
質問 # 26
The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?
- A. A member of the research team
- B. A witness
- C. A family member
- D. A legally acceptable representative
正解：D
解説：
For cognitively impaired participants who may not fully understand the informed consent process, a legally acceptable representative (LAR) must be involved. This ensures that the participant's rights and interests are protected and that consent is obtained ethically and legally.
GCP guidelines mandate that, in cases where participants are unable to provide informed consent, an LAR must be involved to make decisions on their behalf.
"When a participant is cognitively impaired, informed consent must be obtained from a legally acceptable representative to ensure ethical participation." Objectives:
* Safeguard the rights of vulnerable populations.
* Maintain ethical standards in the consent process.
質問 # 27
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?
- A. Training records of site personnel on study protocol, and their study-related duties and functions.
- B. A monitoring report that identifies deviation from the approved protocol.
- C. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
- D. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
正解：A
質問 # 28
Which of the following reports should be retained in participant charts?
- A. Lab reports
- B. Safety reports
- C. DSMB/IDMC reports
- D. IRB/IEC progress reports
正解：A
解説：
Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP).
Therefore, they must be retained in the participant's medical records.
According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.
"Lab reports must be maintained as part of the participant's chart for safety monitoring and data verification." Objectives:
* Maintain comprehensive medical records for each participant.
* Ensure availability of clinical data for audit and review.
質問 # 29
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?
- A. Subject
- B. Sponsor
- C. PI
- D. CRO
正解：B
解説：
The sponsor is responsible for defining the criteria and procedures for subject withdrawal or discontinuation of consent. This includes specifying how data already collected will be handled and whether any follow-up is required. The procedures must be clearly outlined in the study protocol and communicated to the research team.
This answer follows GCP guidelines, which state that the sponsor must ensure that procedures for subject withdrawal are clearly defined and documented.
"The sponsor is responsible for defining procedures to be followed if a subject discontinues participation or withdraws consent, including handling of data collected prior to withdrawal." Objectives:
* Ensure transparent procedures for participant withdrawal.
* Maintain data integrity while respecting participant autonomy.
質問 # 30
A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?
- A. All duties transferred to a CRO should be specified in writing.
- B. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
- C. Any trial-related duties can be documented as transferred by verbal agreement.
- D. The IRB/IEC must approve the transfer of duties to a CRO.
正解：A
解説：
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 forregulatory 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." Objectives:
* Maintain clear documentation of delegated tasks.
* Ensure compliance with regulatory standards.
質問 # 31
A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?
- A. Install an air cooler requiring regular water refills to maintain the room temperature.
- B. Invest in a room temperature controlled IP cabinet and transfer IP to this unit.
- C. Return all IP and request the CRO/Sponsor to directly ship IP to participants.
- D. Continue reporting temperature excursions per the pharmacy manual guidelines.
正解：B
解説：
Investing in a temperature-controlled IP cabinet is the most effective and sustainable solution for maintaining IP stability. This cabinet can consistently regulate temperature without relying on external A/C systems, thereby minimizing the risk of excursions and ensuring compliance with storage requirements.
GCP guidelines state that IP must be stored under controlled conditions as specified by the protocol and product labeling.
"Temperature-controlled storage units should be used when site environmental conditions are not reliable to maintain IP stability." Objectives:
* Ensure IP stability and compliance.
* Mitigate temperature excursion risks effectively.
質問 # 32
A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?
- A. Re-train investigators on recruitment obligations.
- B. Evaluate the screen failures to determine if the protocol needs revision.
- C. Allocate additional monitoring resources to the trial.
- D. Reduce the target sample size based on feedback from the sites.
正解：B
解説：
The high rate of screen failures indicates that the inclusion/exclusion criteria may be too stringent or not appropriately defined. The sponsor should evaluate the reasons for these failures and determine whether the protocol needs adjustment. Revising the criteria may increase recruitment efficiency without compromising the scientific validity of the study.
GCP guidelines advise reviewing and possibly revising protocols when screen failure rates are significantly high to ensure feasible recruitment.
"If a high number of screen failures occurs, the sponsor should evaluate the inclusion/exclusion criteria and consider protocol revisions." Objectives:
* Improve recruitment efficiency.
* Adapt protocol criteria to real-world conditions.
質問 # 33
In a quality management system, in which category do risk reduction activities belong?
- A. Risk Communication
- B. Risk Review
- C. Risk Evaluation
- D. Risk Control
正解：D
解説：
Risk reduction activities fall underRisk Controlwithin a Quality Management System (QMS). Risk control involves implementing measures to reduce identified risks to an acceptable level, including corrective actions, preventive measures, and continuous monitoring. It aims to mitigate potential negative impacts on trial integrity and participant safety.
GCP guidelines highlight that risk control encompasses actions taken to minimize the likelihood and impact of identified risks.
"Risk control is the process of implementing measures to mitigate risks identified during the risk assessment phase." Objectives:
* Implement effective risk management strategies.
* Ensure proactive risk mitigation in clinical trials.
質問 # 34
All site financial matters pertaining to a trial are listed in what document?
- A. Informed consent form
- B. Protocol
- C. Signed contract
- D. Financial disclosure
正解：C
解説：
All financial agreements, including compensation, budgeting, and payment terms related to the conduct of a clinical trial, are documented in the signed contract between the sponsor and the site. This contract outlines the financial responsibilities and ensures transparency and compliance.
GCP guidelines stipulate that financial matters related to the conduct of a trial are to be formally documented in contractual agreements.
"The financial aspects of a clinical trial must be outlined in the signed agreement between the sponsor and the site, ensuring clear understanding of compensation and obligations." Objectives:
* Ensure financial transparency and accountability.
* Maintain compliance with contractual obligations.
質問 # 35
A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?
- A. QA Department
- B. Sponsor
- C. Monitor
- D. Data Manager
正解：C
解説：
After data entry into the Electronic Data Capture (EDC) system, the monitor (typically a Clinical Research Associate - CRA) conducts Source Data Verification (SDV). The monitor compares the data entered in the EDC system with the source documents to ensure accuracy, completeness, and consistency. This step is essential for maintaining data integrity and compliance with GCP standards.
GCP guidelines require that monitors verify data accuracy through SDV as part of routine monitoring responsibilities.
"The monitor is responsible for performing Source Data Verification (SDV) to ensure that the data recorded in the EDC system matches the source documents." Objectives:
* Verify data accuracy in clinical trials.
* Ensure compliance with data management protocols.
質問 # 36
The sponsor should supply a PI with the IP after:
- A. Submission of documents to IRB/IEC and regulatory authority for review.
- B. Approval of protocol by the PI.
- C. Approval of protocol by the sponsor.
- D. Approval/favorable opinion from IRB/IEC and regulatory authority.
正解：D
解説：
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." Objectives:
* Ensure regulatory compliance before initiating IP distribution.
* Protect participant safety and ethical standards.
質問 # 37
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?
- A. Sponsor
- B. PI
- C. CRC
- D. Regulatory Agency
正解：B
解説：
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.
質問 # 38
When designing a clinical trial, why is it important to define the study population?
- A. To determine where to conduct the study
- B. To determine the study objectives
- C. To support the study objectives
- D. To support subject recruitment to the study
正解：C
解説：
Defining the study population is crucial because it ensures that the trial targets the appropriate group for evaluating the investigational product (IP). A well-defined population supports the study objectives by providing reliable and interpretable data that can address the research questions.
GCP guidelines emphasize the need for a clearly defined study population to ensure the generalizability and accuracy of trial results.
"The study population must be clearly defined to ensure that the trial data are relevant and applicable to the intended patient group." Objectives:
* Enhance the scientific validity of clinical trial outcomes.
* Support the accurate interpretation of efficacy and safety data.
質問 # 39
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?
- A. Protocol, informed consent, and clinical trial agreement
- B. IB, site coordinator CVs, and information about payments and compensation available to subjects
- C. Protocol, IB, and information about payments and compensation available to subjects
- D. Protocol, site coordinator CVs, and clinical trial agreement
正解：C
解説：
Before a clinical trial can begin, the IRB/IEC must review the protocol, Investigator's Brochure (IB), and any information related to payments and compensation. This review ensures that the study is ethically sound, scientifically valid, and that participants are informed about any financial considerations.
GCP guidelines specify that essential documents, including the protocol, IB, and compensation details, must be reviewed by the IRB/IEC to maintain ethical oversight.
"The IRB/IEC must evaluate the protocol, IB, and any financial disclosures to ensure ethical compliance and participant protection." Objectives:
* Guarantee ethical oversight in clinical trial conduct.
* Protect participants through informed consent and transparency.
質問 # 40
Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
- A. Sponsor
- B. Applicable site SOPs
- C. PI
- D. Applicable regulatory authorities
正解：D
解説：
The confidentiality and privacy rules protecting human subjects in clinical research are established by applicable regulatory authorities, such as the FDA or EMA, and must be followed by all research sites. These regulations ensure that participants' personal data are handled securely and ethically.
GCP guidelines mandate compliance with local, national, and international regulations regarding data confidentiality and privacy.
"Confidentiality and privacy protections are determined by applicable regulatory authorities and must be adhered to by all study sites." Objectives:
* Protect participant privacy.
* Ensure compliance with data protection regulations.
質問 # 41
Who should vote during the IRB/IEC review and discussion process?
- A. All IRB/IEC members
- B. All members who were involved in the review and discussion
- C. All members who were involved in the review and discussion and non-member experts
- D. All IRB/IEC members and non-member experts
正解：B
解説：
During the IRB/IEC review process, only members who actively participated in the review and discussion are eligible to vote. This ensures that votes are cast by those who are adequately informed about the study and can make an educated decision. Non-member experts may participate in discussions but do not have voting rights.
GCP guidelines state that voting rights in IRB/IEC meetings are limited to members who have thoroughly reviewed and discussed the study, maintaining unbiased and informed decision-making.
"Only IRB/IEC members who were involved in the review and discussion should participate in the voting process." Objectives:
* Ensure informed voting in ethical review processes.
* Maintain integrity and objectivity in IRB/IEC decisions.
質問 # 42
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