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ACRP CCRC Exam Prep Questions and answers 100% correct
Question 1:
The ICH for GCP describes the responsibilities of these 4
groups:
Sponsors Investigators Institutional Review Boards Independent Ethics Committees
CORRECT ANSWER :
Sponsors, Investigators, Institutional Review Boards, Independent Ethics Committees
Question 2:
The International Council on Harmonisation Guidelines for Good Clinical Practice describes the responsibilities of sponsors, investigators, and institutional review boards, as well as
independent ethics committees in order to: [2 Reasons]
CORRECT ANSWER :
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- Safeguard the safety and well-being of trial subjects.
- Ensure the scientific integrity of the study data.
Question 3:
Per this ICH guideline, the conduct of any clinical research trial is ultimately the responsibility of the ___.
CORRECT ANSWER :
Per ICH E6, the investigator has full responsibility.
Question 4:
The investigator can ___ various trial related duties and tasks to any qualified staff in order to ensure good ____ _____.
CORRECT ANSWER :
Delegate; good trial conduct.
Question 5:
In order to ensure good trial conduct, the investigator may delegate various trial tasks and duties presented in this guideline
to any qualified staff. Qualified staff could include:
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CORRECT ANSWER :
Clinical research coordinators, clinical research nurses, clinical trial assistants, pharmacists, etc.
Question 6:
Investigator(s) should be qualified by education, training, and __ to assume responsibility for the proper conduct of the trial, meet all qualifications specified by the applicable regulatory requirement(s), and provide evidence through up-to-date curriculum vitae and/or other relevant documentation.
CORRECT ANSWER :
Experience
Question 7:
The investigator and ____ should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
CORRECT ANSWER :
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Institution
Question 8:
The investigator and institution should permit monitoring and auditing by the _____, and inspection by the appropriate ___.
CORRECT ANSWER :
Sponsor; Regulatory Authorities
Question 9:
It is recommended that the investigator inform the subject's ___ about the subject's participation in the trial if the subject has a _____ and if the subject agrees to the ____ being informed.
CORRECT ANSWER :
Primary physician
Question 10:
Although a subject is not obliged to give his/her reasons for prematurely withdrawing from a trial, the investigator should