CCRC Exam Exam Questions with Complete Solutions

CCRC Exam Exam Questions with Complete Solutions What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? - ANSWER To define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects. What guideline's purpose is to define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects? - ANSWER ICH's Good Clinical Practice: Consolidated Guideline What bearing does the ICH's Good Clinical Practice: Consolidated Guideline have on the Investigator's Brochure? - ANSWER Describes the minimum information that should be included in an Investigator's Brochure (IB) and provides a suggested format. What guideline describes the minimum information that should be included in an Investigator's Brochure (IB) and provides a suggested format? - ANSWER ICH's Good Clinical Practice: Consolidated Guideline What bearing does the ICH guideline have on the conduct of a clinical study and the acceptability of data? - ANSWER Describes the documents required individually and collectively to permit evaluation of the study conduct and data quality What document describes the documents required to permit evaluation of the study conduct and data quality? - ANSWER ICH Good Clinical Practice What are the 3 regulatory agency sponsors of the ICH? - ANSWER European Commission, the Japanese Ministry of Health adn Welfare, and the CDER and CBER of the FDA The European Commission, the Japanese Ministry of Health adn Welfare, and the CDER and CBER of the FDA are the ____ ____ ____ of the ICH. - ANSWER regulatory agency sponsors What 2 parts of the FDA are the american agency sponsors of the ICH? - ANSWER CDER and CBER What does CDER stand for? - ANSWER Center for Drug Evaluation and Research What does CBER stand for? - ANSWER Center for Biologics Evaluation and Research What is the central goal of the harmonization effort? - ANSWER To identify and then reduce differences in technical requirements for drug development among regulatory agencies