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SOCRA CCRP Exam - Topic 3 Question 20 Discussion

Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?
D) India
A) China
B) Switzerland
C) Brazil

SOCRA CCRP Exam - Topic 3 Question 20 Discussion

Actual exam question for SOCRA's CCRP exam
Question #: 20
Topic #: 3
[All CCRP Questions]

Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?

Show Suggested Answer Hide Answer
Suggested Answer: D

India has aligned national regulations with ICH-GCP.

DCGI/ICMR Guidelines (India): Explicitly adopt ICH E6(R2) as part of its Good Clinical Practice standards.

China and Brazil are harmonizing, but full official adoption is noted in India.


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