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Weekly GCP Challenge

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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

Question Number 2:
In the 2008 revision of 21CFR 312.120 (Foreign studies not conducted under IND) which of the following does not appear in the definition of GCP?
A
 Review and approval by an Independent Ethics Committee
B
 Freely given informed consent by study subjects
C
 Inspection by local regulatory authority
D
 Auditing

Question Number 3:
The 2008 revision to 21CFR 312.3 (b) provides an updated definition of an Independent Ethics Committee (IEC), what does it say about the relationship between the terms IEC and IRB?
A
 An IRB is one type of IEC
B
 The two terms are interchangeable
C
 The term IRB should always be used in preference to the term IEC in applications to the FDA
D
 The term IRB should only be used when review which takes place in the US

Question Number 4:
The 2008 revision to 21CFR312.120 (Foreign clinical trials) allows for a waiver of the requirements to be granted by FDA, what is the condition which must be met?
A
 The requirements are too onerous given the economic situation of the country in which the research was conducted
B
 GCP standards in the country are less stringent than FDA requirements
C
 FDA finds that it is in the interest of public health to grant a waiver
D
 There is not enough evidence to support the application without the data from the trial

Question Number 5:
If data from a non-IND clinical trial conducted outside the US is used in support of a marketing authorisation in the US, for how long should the sponsor keep the trial records?
A
 3 years after the end of the clinical trial
B
 2 years after the agency decision on the marketing application
C
 5 years after the end of the clinical trial
D
 There is no specific requirement

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