Exam (elaborations)
GOOD CLINICAL PRACTICE QUIZZES -SET 1 QUESTIONS AND ANSWERS
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GOOD CLINICAL PRACTICE QUIZZES -SET 1 QUESTIONS AND ANSWERS...
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Any specific member of the clinical trial team (e.g., associates, residents,research fellows) assigned and overseen by the investigator at a trial site to
carry out crucial trial-related tasks and/or make crucial trial-related decisions.
a. The principal investigator
c. A sub-investigator
b. Coordinator of the study
d. ANSWER b. sub-investigator - coordinating investigator
Any unfortunate medical event that is life-threatening, causes mortality at any
dose, necessitates inpatient hospitalization or the extension of an existing
hospital stay, causes considerable or ongoing disability or incapacity, or is a
congenital aberration or birth defect.
A major adverse event
b. Unfavorable medication reaction
b. unanticipated negative medication reaction
c. adverse event - ANSWER a. adverse event that is serious
Everything required for the reconstruction and assessment of a clinical trial that
is contained in original records and certified copies of original records of
clinical results, observations, or other activities.
, a. Protocol
a. Report on clinical studies
c. A type of informed consent
d. The audit report
e. Source information - ANSWER e. Source information
People who desire to volunteer for a clinical trial may be overly swayed by the
expectation—justifiable or not—of rewards for taking part or of defensive
action from higher-ranking officials if they decline to take part.
Part-time investigators
b. organizing researchers
c. unbiased observers
d. susceptible individuals
e. Researchers
f. trial participants - ANSWER d. susceptible participants
documents that, both separately and together, enable assessment of the study's
methodology and the caliber of the data generated.
Forms for informed consent
c. keeping an eye on reports
b. Forms for case reports
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