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CCRC Exam questions with answers
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CCRC Exam questions with answers
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CCRC ExamProtocols - correct 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 - correct 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 - correct 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 - correct 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 - correct answer ✔✔Continue to collect long-term safety data and gather
optimal use info
Conduct AFTER regulatory approves IND
Open label
IND - Investigational New Drug - correct answer ✔✔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 - correct answer ✔✔1)Advertisement for subject recruitment
2) signed inform consent
3) source docs
4) subject enrollment logs
5) final report by investigator to IRB
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