What document would an investigator reference to learn more about the

previous clinical and nonclinical results of studies of the IP? ✔️ IB

When considering participation in a study, the investigator should

determine if he/she: ✔️ sees enough patients who would qualify for the

study.

When would an impartial witness be needed during the consent process

for an illiterate subject? ✔️ 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?

✔️ 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? ✔️ A research assistant who

is certified to administer the psychometric test