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Medicine /Overview of ICH GCP Quiz

Overview of ICH GCP Quiz

Medicine5 CardsCreated 3 months ago

This deck covers key concepts related to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, including their purpose, application, and regulatory context.

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A primary purpose of the ICH is to:

Minimize the need for redundant research.
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Key Terms

Term
Definition
A primary purpose of the ICH is to:
Minimize the need for redundant research.
The ICH GCP Guidelines:
Set standards for the design, conduct, monitoring and reporting of clinical research.
The ICH E6 GCP describes standards that apply to:
Investigators, sponsors, and IRBs.
In the United States, following the ICH E6 GCP is:
Voluntary for FDA-regulated drug studies.
The FDA will apply:
The Code of Federal Regulations.
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Overview of ICH GCP Quiz
TermDefinition
A primary purpose of the ICH is to:
Minimize the need for redundant research.
The ICH GCP Guidelines:
Set standards for the design, conduct, monitoring and reporting of clinical research.
The ICH E6 GCP describes standards that apply to:
Investigators, sponsors, and IRBs.
In the United States, following the ICH E6 GCP is:
Voluntary for FDA-regulated drug studies.
The FDA will apply:
The Code of Federal Regulations.