Challenge: ICH GCP - Informed Consent
Question Number 1

What does ICH GCP Section 4.8 say about the factors that the investigator should comply with?

"In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirements, and should adhere to GCP and to the ethical principles that.........."
A
are stated in the protocol
B
have their origin in the Declaration of Helsinki
C
are stated by the IRB/IEC
D
all of the above

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