CCRC Exam questions and answers graded A+ 2023/2024

CCRC ExamWhat is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? - correct 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? - correct 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? - correct 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? - correct 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? - correct 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? - correct answer ICH Good Clinical Practice What are the 3 regulatory agency sponsors of the ICH? - correct 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. - correct answer regulatory agency sponsors What 2 parts of the FDA are the american agency sponsors of the ICH? - correct answer CDER and CBER