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CITI CRC Course Training questions with actual answers.
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CITI CRC Course Training questionswith actual answers.
What is the main objective of a phase 2 clinical trial?
A) To test a new molecule in subjects with the disease of interest to obtain safety information and
preliminary evidence of efficacy
B) To obtain additional safety information on a marketed drug
C) To test a new molecule on thousands of human subjects in order to confirm the safety and efficacy
profile of a new drug on a large sample size.
D) To test a new molecule for the first time in human subjects ANS -A. To test a new molecule in subjects
with the disease of interest to obtain safety information and preliminary evidence of efficacy
The Principal Investigator (PI) can delegate clinical trial site responsibilities to the following individuals
on the study team as long as they are qualified by education, training, experience, and are properly
documented and listed on the site delegation log.
A) The pharmaceutical company sponsoring the study
B) Clinical research coordinator (CRC) and clinical research associate (CRA).
C) IRB/IEC
D) CRC, sub-I, and site support team (phlebotomist, medical assistant, subject recruiter ANS -CRC, sub-
investigator (SI), and site support team (phlebotomist, medical assistant, subject recruiter)
What is the most important factor to consider in a site's decision to participate in competing clinical
trials?
A) Clinical trial business is competitive so it is acceptable to participate in as many trials as possible.
B) There is an imminent risk for struggle in prioritizing study-related activities when a site is involved in
similar clinical trials for different sponsors.
C) The sponsor will be disappointed with a site's level of engagement if it turns down an opportunity to
participate.
D) Competing studies are more financially rewarding to the site. ANS -There is an imminent risk for
struggle in prioritizing study-related activities when a site is involved in similar clinical trials for different
sponsors.
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