CCRC Exam Study Guide

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 *AIM: define dose evaluate short term safety and efficacy in patients with disease dose response, dose tolerance, AE's Phase 3 - Answer- -Evaluate overall benefit to risk in large group of patients -broader eligibility, 2 or 3 tx groups. controlled or uncontrolled *AIM: establish long-term safety and efficacy with selected doses in broad subject sample dosing invervals, drug-drug interactions, risk-benefit pivotal to FDA approval Phase 4 - Post Marketing - Answer- Continue to collect long-term safety data and gather optimal use info Conduct AFTER regulatory approves IND Open label IND - Investigational New Drug - Answer- Application - FDA form 1571 Permit to pe