Ccrc Exam Solved 100% Correct!!

CCRC EXAM SOLVED 100% CORRECT!! Protocols 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 -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 -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 -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 Continue to collect long-term safety data and gather optimal use info Conduct AFTER regulatory approves IND Open label IND - Investigational New Drug Application - 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 1)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 1) 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 Need 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 1571: IND application 1572: Statement of Investigator 482: Notice of inspection 483: inspectional observations 3454: certification-financial interests of clinical investigators 3455: disclosure-financial interests of clinical investigators 3500: voluntary reporting of AE's and product problems 3500A: for use by user-facilities distributors, manufacturers for mandatory reporting Investigators Brochure compiles the clinical and nonclinical data on product relevant to study. may be official labeling for pdt. supplied by sponsor; given to investigator. provides clear understanding of risks, AE's and tests needed for trial Investigators Brochure Contents 1) General considerations - title/confidentiality 2) intro 3) phys, chem, pharma properties 4) nonclinical studies 5) nonclin pharma, animals, toxicology 6) effects in humans 7) safety and efficacy 8) marketing experience 9) summary of data and guidance for investigator IND (Invest. New Drug) Studies PK: pharmacokenetics: evaluates time course of an IP in a biologic system and mathematically describes absorption, distribution, metabolism and excretion. Typically Phase 1, maybe Phase 2, but can take place during any phase PD: Pharmacodynamics: evaluates physiologic effects of an IP on a biologic system: bp, heart rate, EKG Typically Phase 1 but can take place during any phase Bioavailability (BA) measures rate and extent to which active ingredient is absorbed from IP and becomes available at site of action Bioequivalence (BE) measures the absence of a significant difference in rate and extent to which active ingredient in IP becomes available at site of action when administered at same dose BA and BE under similar conditions: -dose proportionality -metabolize -drug-drug interaction Demonstrating BA and BE typically serves as sufficient evidence for regulatory approval of generic invest. pdts Treatment IND Studies -permitted by FDA if data shows an IP being tested under an IND may be effective, doesn't pose unreasonable risk, and gives subject access to tx for serious disease where no other comparable tx is available -must follow protocol, IB, IRB approval and inf consent -data exists to demonstrate efficacy of drug Blinding Open label: unblinded single: 1 party doesn't know tx double: 2 or more parties don't know tx (flaxseed study)