ICH/GCP Flashcards
1
Q
ICH
A
International Council for Harmonization
2
Q
The ICH GCP guidelines are for which countries?
A
The European Union, Japan, and U.S.A
3
Q
ICH GCP was finalized when?
A
November 2016 - Describes the responsibilities and expectations of participants in the conduct of clinical trials including investigators, monitors, sponsors, and IRBs.
4
Q
What is GCP?
A
International ethical and scientific quality standards for human subject research.
5
Q
How many principles in the ICH GCP?
A
13 principles/guidelines
