ACRP ACRP-CP 問題集

質問 1：
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. Protocol, IB, and information about payments and compensation available to subjects
C. Protocol, site coordinator CVs, and clinical trial agreement
D. IB, site coordinator CVs, and information about payments and compensation available to subjects
正解：B
解説: (Topexam メンバーにのみ表示されます)

質問 2：
Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?
A. Sponsor-Investigator
B. CRO
C. Regulatory authority
D. IRB/IEC
正解：A
解説: (Topexam メンバーにのみ表示されます)

質問 3：
Which of the following elements of the Informed Consent are NOT required?
A. A description of potential benefits
B. Subject legal rights can be waived
C. Statement that study involves research
D. A description of any reasonably foreseeable risks or discomforts
正解：B
解説: (Topexam メンバーにのみ表示されます)

質問 4：
A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?
A. Establish a DSMB/IDMC
B. Develop a monitoring plan
C. Conduct routine investigators' meetings
D. Draft a CAPA plan
正解：A
解説: (Topexam メンバーにのみ表示されます)

質問 5：
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.
正解：C
解説: (Topexam メンバーにのみ表示されます)

質問 6：
Who takes responsibility for initiating a clinical trial?
A. Sponsor
B. CRO
C. IRB/IEC
D. Investigator
正解：A
解説: (Topexam メンバーにのみ表示されます)

質問 7：
During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?
A. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
B. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
C. Immediately unblind the entire trial to ensure patient safety.
D. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
正解：D
解説: (Topexam メンバーにのみ表示されます)