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Exam (elaborations)

CCRC Exam Study Guide Solutions

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CCRC Exam Study Guide Solutions 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/Doc...

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  • November 3, 2024
  • 13
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • CCRC
  • CCRC
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KaylinHoffman
Copyright © KAYLIN 2024/2025 ACADEMIC YEAR. ALL RIGHTS RESERVED FIRST PUBLISH NOVEMBER, 2024




CCRC Exam Study Guide Solutions


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


Copyright ©Stuvia International BV 2010-2024 Page 1/13

, Copyright © KAYLIN 2024/2025 ACADEMIC YEAR. ALL RIGHTS RESERVED FIRST PUBLISH NOVEMBER, 2024


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

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