CCRC Exam 2
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? - answerICH'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? - answerICH'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? - answerDescribes 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? - answerICH Good Clinical Practice
What are the 3 regulatory agency sponsors of the ICH? - answerEuropean 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. - answerregulatory
agency sponsors
What 2 parts of the FDA are the american agency sponsors of the ICH? - answerCDER
and CBER
What does CDER stand for? - answerCenter for Drug Evaluation and Research
What does CBER stand for? - answerCenter for Biologics Evaluation and Research
What is the central goal of the harmonization effort? - answerTo identify and then
reduce differences in technical requirements for drug development among regulatory
agencies
, What organization's goal is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies? - answerharmonization
effort
Why was the ICH organized? - answerto provide an opportunity for development of
tripartite harmonization initiatives based on input from both regulatory and industry
representatives
What organization was created to provide an opportunity for development of tripartite
harmonization initiatives based on input from both regulatory and industry
representatives - answerICH (International Conference on Harmonization)
What does ICH stand for? - answerInternational Conference on Harmonization
The ICH seeks to harmonize requirements from which three regions? -
answerEuropean Union, Japan, United States
The ICH is concerned with harmonization of _____ with the European Union, Japan,
and the United states - answertechnical requirements for registration of pharmaceutical
products
The ICH Secretariat coordinates ____ documentation. - answerICH
What organization is the ICH Secretariat affiliated? - answerThe international
Federation of Pharmaceutical Manufacturers Association (IFPMA)
What does IFPMA stand for? - answerInternational Federation of Pharmaceutical
Manufacturers Association
The IFPMA is associated with which part of ICH? - answerICH Secretariat
What are the three industry association sponsors of ICH? - answerEuropean Federation
of Pharmaceutical Industries Association
Japanese Pharmaceutical Manufacturers Association
Pharmaceutical Research and Manufacturers of America
What is the European industry association sponsor of ICH? - answerEuropean
Federation of Pharmaceutical Industries Association
What is the Japanese industry association sponsor of ICH? - answerJapanese
Pharmaceutical Manufacturers Asssociation
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? - answerICH'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? - answerICH'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? - answerDescribes 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? - answerICH Good Clinical Practice
What are the 3 regulatory agency sponsors of the ICH? - answerEuropean 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. - answerregulatory
agency sponsors
What 2 parts of the FDA are the american agency sponsors of the ICH? - answerCDER
and CBER
What does CDER stand for? - answerCenter for Drug Evaluation and Research
What does CBER stand for? - answerCenter for Biologics Evaluation and Research
What is the central goal of the harmonization effort? - answerTo identify and then
reduce differences in technical requirements for drug development among regulatory
agencies
, What organization's goal is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies? - answerharmonization
effort
Why was the ICH organized? - answerto provide an opportunity for development of
tripartite harmonization initiatives based on input from both regulatory and industry
representatives
What organization was created to provide an opportunity for development of tripartite
harmonization initiatives based on input from both regulatory and industry
representatives - answerICH (International Conference on Harmonization)
What does ICH stand for? - answerInternational Conference on Harmonization
The ICH seeks to harmonize requirements from which three regions? -
answerEuropean Union, Japan, United States
The ICH is concerned with harmonization of _____ with the European Union, Japan,
and the United states - answertechnical requirements for registration of pharmaceutical
products
The ICH Secretariat coordinates ____ documentation. - answerICH
What organization is the ICH Secretariat affiliated? - answerThe international
Federation of Pharmaceutical Manufacturers Association (IFPMA)
What does IFPMA stand for? - answerInternational Federation of Pharmaceutical
Manufacturers Association
The IFPMA is associated with which part of ICH? - answerICH Secretariat
What are the three industry association sponsors of ICH? - answerEuropean Federation
of Pharmaceutical Industries Association
Japanese Pharmaceutical Manufacturers Association
Pharmaceutical Research and Manufacturers of America
What is the European industry association sponsor of ICH? - answerEuropean
Federation of Pharmaceutical Industries Association
What is the Japanese industry association sponsor of ICH? - answerJapanese
Pharmaceutical Manufacturers Asssociation
