CCRC Exam Questions With Correct Answers

CCRC /




Exam Questions With Correct Answers
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Clinical /



Trial -
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CORRECT
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ANSWERS(S)✔✔process
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of
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studying
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human
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subjects
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to
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assess
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the
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effect
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of
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a /



particular
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intervention
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(Drug,
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biologic,
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device,
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procedure
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or behavior change) on a pre specified set of measurable events.
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,Endpoint /



or
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Outcome -
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CORRECT
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ANSWERS(S)✔✔Clinical
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event, measurable indicator, subject reported response
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Feasibility /



of
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a /



Study -
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CORRECT
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ANSWERS(S)✔✔Assessment
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of
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resource
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needs,
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regulator
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requirements,
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and potential level of risk of harm for human subjects participating
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in study
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Necessary /



controls
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in Clinical trials - CORRECT ANSWERS(S)✔✔Inclusion/ exclusion
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criteria(identify
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target),
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,/ randomization(avoid /



/ bias), /



/ Blinding(avoid /



/ observation /



/ bias), Primary and secondary endpoints(prove hypothesis)
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Current /



Good Manufacturing Practices - CORRECT ANSWERS(S)✔✔cGMP
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Food /



and
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Drug
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Administration (FDA) - CORRECT ANSWERS(S)✔✔federal agency
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responsible
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for
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the
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regulation
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and enforcement of drug evaluation and distribution policies
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Investigational /



New
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Drug
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(IND) -
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CORRECT
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ANSWERS(S)✔✔application
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to the FDA that contains all the animal and cell testing data
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, Length /



of
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time
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a /



sponsor
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must
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wait
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before
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starting
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clinical
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trials
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after
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IND
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submission to FDA - CORRECT ANSWERS(S)✔✔30 calendar days
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Non-
significant /



Risk
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Devices -
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CORRECT ANSWERS(S)✔✔Tongue depressor, adhesive bandages
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Premarket /



Review -
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CORRECT
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ANSWERS(S)✔✔FDA
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