ACRP CCRC PRACTICE EXAM 2024 QUESTIONS AND
ANSWERS/ ACRP PRACTICE EXAM 2024-2025 QUESTIONS AND
ANSWERS
What are the 3 regulatory agency sponsors of the ICH? - 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. - regulatory agency
sponsors
What 2 parts of the FDA are the american agency sponsors of the ICH? - CDER and
CBER
What does CDER stand for? - Center for Drug Evaluation and Research
What does CBER stand for? - Center for Biologics Evaluation and Research
What is the central goal of the harmonization effort? - To 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? - harmonization effort
Why was the ICH organized? - to 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 - ICH (International Conference on Harmonization)
What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? - 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? - ICH's Good Clinical Practice: Consolidated Guideline
, What bearing does the ICH's Good Clinical Practice: Consolidated Guideline have on
the Investigator's Brochure? - 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? - 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? - 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? - ICH Good Clinical Practice
What does ICH stand for? - International Conference on Harmonization
The ICH seeks to harmonize requirements from which three regions? - European Union,
Japan, United States
The ICH is concerned with harmonization of _____ with the European Union, Japan,
and the United states - technical requirements for registration of pharmaceutical
products
The ICH Secretariat coordinates ____ documentation. - ICH
What organization is the ICH Secretariat affiliated? - The international Federation of
Pharmaceutical Manufacturers Association (IFPMA)
What does IFPMA stand for? - International Federation of Pharmaceutical
Manufacturers Association
The IFPMA is associated with which part of ICH? - ICH Secretariat
What are the three industry association sponsors of ICH? - European Federation of
Pharmaceutical Industries Association
Japanese Pharmaceutical Manufacturers Association
Pharmaceutical Research and Manufacturers of America
What is the European industry association sponsor of ICH? - European Federation of
Pharmaceutical Industries Association
ANSWERS/ ACRP PRACTICE EXAM 2024-2025 QUESTIONS AND
ANSWERS
What are the 3 regulatory agency sponsors of the ICH? - 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. - regulatory agency
sponsors
What 2 parts of the FDA are the american agency sponsors of the ICH? - CDER and
CBER
What does CDER stand for? - Center for Drug Evaluation and Research
What does CBER stand for? - Center for Biologics Evaluation and Research
What is the central goal of the harmonization effort? - To 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? - harmonization effort
Why was the ICH organized? - to 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 - ICH (International Conference on Harmonization)
What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? - 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? - ICH's Good Clinical Practice: Consolidated Guideline
, What bearing does the ICH's Good Clinical Practice: Consolidated Guideline have on
the Investigator's Brochure? - 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? - 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? - 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? - ICH Good Clinical Practice
What does ICH stand for? - International Conference on Harmonization
The ICH seeks to harmonize requirements from which three regions? - European Union,
Japan, United States
The ICH is concerned with harmonization of _____ with the European Union, Japan,
and the United states - technical requirements for registration of pharmaceutical
products
The ICH Secretariat coordinates ____ documentation. - ICH
What organization is the ICH Secretariat affiliated? - The international Federation of
Pharmaceutical Manufacturers Association (IFPMA)
What does IFPMA stand for? - International Federation of Pharmaceutical
Manufacturers Association
The IFPMA is associated with which part of ICH? - ICH Secretariat
What are the three industry association sponsors of ICH? - European Federation of
Pharmaceutical Industries Association
Japanese Pharmaceutical Manufacturers Association
Pharmaceutical Research and Manufacturers of America
What is the European industry association sponsor of ICH? - European Federation of
Pharmaceutical Industries Association
