well answered and simple to understand latest CCRC Exam quizs

well answered and simple to understand latest CCRC Exam quizs Protocols - ANSWERS1) 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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERSContinue to collect long-term safety data and gather optimal use info Conduct AFTER regulatory approves IND Open label IND - Investigational New Drug - ANSWERSApplication - FDA form 1571 Permit to perform research with a specific investigational new drug on humans for the first time in the US Includes: background info, rationale, sponsors plan Continually amended by sponsors to reflect protocol changes and new info Effective 30 days after receipt by FDA Updated annually by sponsors Documents/Filing Investigator Only - ANSWERS1)Advertisement for subject recruitment 2) signed inform consent 3) source docs 4) subject enrollment logs 5) final report by investigator to IRB 6) completed subject ID code list Documents/Filing Sponsor Only - ANSWERS1) sample of label attached to IP container 2) certificate of analysis of IP product shipped 3) master randomization list 4) pre-trial monitoring report 5) certificate of analysis for new batched of IP 6) monitoring visit reports 7) audit certificate 8) final trial close-out monitoring report 9) treatment allocation and decoding docs All other forms are in BOTH sponsor and investigator files Form 1572 - Statement of Investigator - ANSWERSNeed to complete if sponsor is intending to file for marketing approval of an IP in the US Commitment to: 1) conduct investigation with protocol, FDA regs and IRB conditions 2) make changes only with appropriate sponsor and IRB approval 3) Ensure informed consent requirements are met 4) report AE's 5) keep current records 6) personally conductors supervise investigation 7) read and understand investigator brochure 8) ensure IRB reviews and approves the study initially and on a continuing basis Forms: FDA - ANSWERS1571: IND application 1572: Statement of Investigator 482: Notice of inspection 483: inspectional observations 3454: certification-financial interests of clinical investigators