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1571 ` - ANSWERIND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - ANSWERInvestigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB - ANSWERClinic...

What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - ANSWER Investigators brochure

Crossover - ANSWER when each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons Parallel - ANSWER when subjects are randomized to 1 of 2 or more arms, each arm being allocated a different treatment. Each treatment will inclu...

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two tim...

Belmont Report (1979) - ANSWER ethical principles and guidelines for the protection of human subjects of research. respect for persons - ANSWER individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - ANSWER A per...

A screening log is useful for determining which of the following? 1. trial reimbursement 2. subject IP compliance 3. active recruitment efforts 4. trends regarding evaluable subjects - ANSWER 1 and 3 only. E6 8.3.20 A screening log will provide evidence of an investigator's efforts to recr...