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What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP? âœ”ï¸ IB
When considering participation in a study, the investigator should
determine if he/she: âœ”ï¸ sees enough patients who would qualify for the
study.
When would an impartial witness be needed during the consent process
for an illiterate subject? âœ”ï¸ To observe the consent process
During a monitoring visit, what records would a CRA reference to verify
a subject's compliance to the study visit schedule and assessments?
âœ”ï¸ Electronic medical record
A site is screening potential subjects for a study looking at mild cognitive
impairment. One of the inclusion criteria is a score of 25 or less on a
psychometric test, a research-specific tool which measures cognitive
ability. Which of the following individuals can administer the
psychometric test to the potential subjects? âœ”ï¸ A research assistant who
is certified to administer the psychometric test
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