Health Medical Homework Help

Instructions:

1. Review the Prot-SAP-Brocsupp Protocol in last week’s Phase I Drug Studies.
2. Go to the Schema and answer these questions
   1. What sort of information, do you feel, we need to collect from participants about their smoking history? How often would we need to collect this data?
   2. Where, within the protocol, did you look for further resources to support your answer for #1?
   3. Explain the High-Low Arm regimen then explain the low-high arm regimen. Where, within the protocol, did you find this data?
   4. What do participants provide to receive another supply of Investigational Product? Where did you locate this information within the protocol?
   5. Go to section 5.5 Concomitant Medications. What types of medications will be documented? What information should be included?
   6. Go to section 6.6 Packaging and Labeling. How many pills per day will participants take (provide the range)?
   7. For how many days will participants take the pills (provide the range)?
   8. In total, how many pills will a participant potentially take (provide the range)?
   9. How many pills does each bottle contain?
   10. How many pills would a participant randomized to take 4 pills for 14 days bring back to the office?
   11. How many pills would a participant randomized to take 8 pills for 10 days bring back to the office?
   12. If a participant misses a dose, should they double up the next day? Where did you locate this information in the protocol?
   13. What are 2 of the known side effects of the IP? Where did you locate this information?
   14. How many times, total, will participants have research blood collection?
   15. How often will participants answer a questionnaire?