SOCRA Certified Clinical Research Professional (CCRP) - CCRP무료 덤프문제 풀어보기
The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?
정답: B
설명: (Fast2test 회원만 볼 수 있음)
In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?
정답: A
설명: (Fast2test 회원만 볼 수 있음)
In determining the classification of risk for a study involving a medical device, it is necessary to consider the:
정답: A
설명: (Fast2test 회원만 볼 수 있음)
Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?
정답: A
설명: (Fast2test 회원만 볼 수 있음)
In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties andfunctions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?
정답: A
설명: (Fast2test 회원만 볼 수 있음)
During an IND study closeout, a monitor discovered remaining investigational product. Which procedures must be followed for disposition?
정답: A
설명: (Fast2test 회원만 볼 수 있음)