ACRP ACRP-CP 問題集

質問 1：
A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?
A. As soon as the protocol amendment is submitted to the IRB/IEC
B. After the original planned data collection is completed
C. After the protocol amendment is approved by the IRB/IEC
D. When the need for the additional data is discovered
正解：C
解説: (Topexam メンバーにのみ表示されます)

質問 2：
At a close-out visit, which document should be retained only at the site?
A. Final trial close-out monitoring report
B. IP accountability
C. Treatment allocation
D. Subject identification code list
正解：D
解説: (Topexam メンバーにのみ表示されます)

質問 3：
Who is responsible for the ongoing safety evaluation of the IP?
A. Sponsor
B. PI
C. Regulatory agency
D. IRB/IEC
正解：A
解説: (Topexam メンバーにのみ表示されます)

質問 4：
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, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
B. A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
C. A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
D. A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
正解：D
解説: (Topexam メンバーにのみ表示されます)

質問 5：
Who determines the age of assent for pediatric studies?
A. Sponsor
B. PI
C. Parent
D. IRB/IEC
正解：D
解説: (Topexam メンバーにのみ表示されます)

質問 6：
An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:
A. Investigators participating in the trial.
B. Independent qualified individuals.
C. Executive board members.
D. Regulatory authority expert advisors.
正解：B
解説: (Topexam メンバーにのみ表示されます)

質問 7：
A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?
A. Standard Operating Procedure
B. Data & Safety Monitoring Plan
C. Investigator's Brochure
D. Clinical Monitoring Plan
正解：A
解説: (Topexam メンバーにのみ表示されます)

質問 8：
A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?
A. No treatment
B. Active control
C. Alternate dose
D. Placebo
正解：D
解説: (Topexam メンバーにのみ表示されます)