PharmaSchool GCP Challenge: FDA - new regulation governing foreign clinical trials

Challenge: FDA - new regulation governing foreign clinical trials
Question Number 1
According to the 2008 revision of 21 CFR 312.120 which criteria must apply for FDA to accept data from a non-IND foreign clinical trial in support of an IND or NDA?
	A	Drug sourced from US and trial conducted to GCP
	B	IEC constituted according to IRB regulations and trial conducted to GCP
	C	Information for subjects approved by FDA and trial conducted to GCP
	D	FDA able to inspect on-site if required and trial conducted to GCP