CCRC Exam with Questions and Answers

CCRC Exam with Questions and Answers Protocols ANSWER 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance 12) ethics 13) data handling and record keeping 14) financing and insurance 15) publication policy 16) supplements Phase 1 ANSWER -intro of new drug/investigational product into humans -healthy population (exception: oncology and HIV) -design: single dose, open label, max tolerated dose -PR, PD, BA, BE, dosing, metabolis *focus is SAFETY Phase 2 ANSWER -Intro to subjects with disease -design: compare with placebo (exception: cancer and antibiotics), double blind