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[Show more]What are expected or possible consequences of over-estimation of recruitment potential? Answer - The trial will overrun its projected timeline 
- The recruitment period will be prolonged and more sites may be needed 
- The study will not have sufficient data within the required timeframe and will be...
Preview 4 out of 42 pages
Add to cartWhat are expected or possible consequences of over-estimation of recruitment potential? Answer - The trial will overrun its projected timeline 
- The recruitment period will be prolonged and more sites may be needed 
- The study will not have sufficient data within the required timeframe and will be...
ICH E6 (R2) Answer ICH guideline that is known as GCP guideline 
 
21 CFR 312.3 Answer Individual who actually conducts a clinical investigation. In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. 
 
Phase I Answer Clinical tr...
Preview 2 out of 15 pages
Add to cartICH E6 (R2) Answer ICH guideline that is known as GCP guideline 
 
21 CFR 312.3 Answer Individual who actually conducts a clinical investigation. In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. 
 
Phase I Answer Clinical tr...
1. 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 compliance is he? 
 
A. 50% 
 
B. 64% 
 
C. 78% 
 
D. 100% 
 
1. Answer: A 
 
- Math Calculation: 120 = # dispensed, 120-88 (...
Preview 4 out of 58 pages
Add to cart1. 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 compliance is he? 
 
A. 50% 
 
B. 64% 
 
C. 78% 
 
D. 100% 
 
1. Answer: A 
 
- Math Calculation: 120 = # dispensed, 120-88 (...
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