CCRC Exam Questions & Answers 100% Verified
(Grade A+)
Save
Terms in this set (159)
What is the purpose of the To define Good clinical practice and provide a unified
ICH's Good Clinical standard for designing, conduction, recording and
Practice: consolidated reporting trials that involve participation of human
Guideline? subjects.
What guideline's purpose ICH's Good Clinical Practice: Consolidated Guideline
is to define Good clinical
practice and provide a
unified standard for
designing, conduction,
recording and reporting
trials that involve
participation of human
subjects?
What bearing does the Describes the minimum information that should be
ICH's Good Clinical included in an Investigator's Brochure (IB) and
Practice: Consolidated provides a suggested format.
Guideline have on the
Investigator's Brochure?
,What guideline describes ICH's Good Clinical Practice: Consolidated Guideline
the minimum information
that should be included in
an Investigator's Brochure
(IB) and provides a
suggested format?
What bearing does the Describes the documents required individually and
ICH guideline have on the collectively to permit evaluation of the study conduct
conduct of a clinical study and data quality
and the acceptability of
data?
What document describes ICH Good Clinical Practice
the documents required to
permit evaluation of the
study conduct and data
quality?
What are the 3 regulatory European Commission, the Japanese Ministry of
agency sponsors of the Health adn Welfare, and the CDER and CBER of the
ICH? FDA
The European regulatory agency sponsors
Commission, the Japanese
Ministry of Health adn
Welfare, and the CDER
and CBER of the FDA are
the ____ ____ ____ of the ICH.
What 2 parts of the FDA CDER and CBER
are the american agency
sponsors of the ICH?
What does CDER stand Center for Drug Evaluation and Research
for?
What does CBER stand Center for Biologics Evaluation and Research
for?
, To identify and then reduce differences in technical
What is the central goal of
requirements for drug development among
the harmonization effort?
regulatory agencies
What organization's goal is harmonization effort
to identify and then
reduce differences in
technical requirements for
drug development among
regulatory agencies?
to provide an opportunity for development of
Why was the ICH
tripartite harmonization initiatives based on input from
organized?
both regulatory and industry representatives
What organization was ICH (International Conference on Harmonization)
created to provide an
opportunity for
development of tripartite
harmonization initiatives
based on input from both
regulatory and industry
representatives
What does ICH stand for? International Conference on Harmonization
The ICH seeks to European Union, Japan, United States
harmonize requirements
from which three regions?
The ICH is concerned with technical requirements for registration of
harmonization of _____ with pharmaceutical products
the European Union,
Japan, and the United
states
The ICH Secretariat ICH
coordinates ____
documentation.
(Grade A+)
Save
Terms in this set (159)
What is the purpose of the To define Good clinical practice and provide a unified
ICH's Good Clinical standard for designing, conduction, recording and
Practice: consolidated reporting trials that involve participation of human
Guideline? subjects.
What guideline's purpose ICH's Good Clinical Practice: Consolidated Guideline
is to define Good clinical
practice and provide a
unified standard for
designing, conduction,
recording and reporting
trials that involve
participation of human
subjects?
What bearing does the Describes the minimum information that should be
ICH's Good Clinical included in an Investigator's Brochure (IB) and
Practice: Consolidated provides a suggested format.
Guideline have on the
Investigator's Brochure?
,What guideline describes ICH's Good Clinical Practice: Consolidated Guideline
the minimum information
that should be included in
an Investigator's Brochure
(IB) and provides a
suggested format?
What bearing does the Describes the documents required individually and
ICH guideline have on the collectively to permit evaluation of the study conduct
conduct of a clinical study and data quality
and the acceptability of
data?
What document describes ICH Good Clinical Practice
the documents required to
permit evaluation of the
study conduct and data
quality?
What are the 3 regulatory European Commission, the Japanese Ministry of
agency sponsors of the Health adn Welfare, and the CDER and CBER of the
ICH? FDA
The European regulatory agency sponsors
Commission, the Japanese
Ministry of Health adn
Welfare, and the CDER
and CBER of the FDA are
the ____ ____ ____ of the ICH.
What 2 parts of the FDA CDER and CBER
are the american agency
sponsors of the ICH?
What does CDER stand Center for Drug Evaluation and Research
for?
What does CBER stand Center for Biologics Evaluation and Research
for?
, To identify and then reduce differences in technical
What is the central goal of
requirements for drug development among
the harmonization effort?
regulatory agencies
What organization's goal is harmonization effort
to identify and then
reduce differences in
technical requirements for
drug development among
regulatory agencies?
to provide an opportunity for development of
Why was the ICH
tripartite harmonization initiatives based on input from
organized?
both regulatory and industry representatives
What organization was ICH (International Conference on Harmonization)
created to provide an
opportunity for
development of tripartite
harmonization initiatives
based on input from both
regulatory and industry
representatives
What does ICH stand for? International Conference on Harmonization
The ICH seeks to European Union, Japan, United States
harmonize requirements
from which three regions?
The ICH is concerned with technical requirements for registration of
harmonization of _____ with pharmaceutical products
the European Union,
Japan, and the United
states
The ICH Secretariat ICH
coordinates ____
documentation.
