ACRP CP CRUCIAL POSSIBLE QUESTIONS & ANSWERS 2024
1571 - IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB - Clinical and non-clinical data on the investigational product that is relevant to the study in human subjects; supplied prior to regulatory approval Study type - Open Label - everyone knows the treatment Study type - Single blind - one party knows Tx, usually the patient does not know but the monitoring team does Study type - Double Blind - 2 or more people are blinded, usually the patient and monitoring tram do not know which drug is given.
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- ACRP clinical Research professional
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- February 4, 2024
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- 7
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- 2023/2024
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- Exam (elaborations)
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