Bob, a clinical development lead at Amco Pharmaceuticals, needs to determine where in the CFR he can
find guidance regarding the regulations concerning the integrity of clinical trials. Where should he look?
- 21 CFR Part 56
The responsibility of Sponsor (Company) does NOT include which of the following? - Delegating the
responsibility of recall and quality system compliance on the Distributors.
Which of the following are TRUE with regard to the recall of product? Select all that apply. - The
Company (manufacturer of record) may initiate a recall.
The FDA may initiate a recall.
Distributors may initiate a recall at any time.
Classification of a recall is found in the: - Enforcement Policy
The primary role of the IRB is to - Ensure the protection of subjects in a clinical study.
Third Tier Compliance is - Enforcement Policy
Which of the following statement(s) is/are true? Select all that apply. - The Quality system in the US for
devices is not identical to that of pharmaceuticals (Good Manufacturing Practices - GMPs).
Quality Systems are required to be in place for the US for medical devices as well as pharmaceuticals.
Second tier compliance includes (select all that apply) - Good Laboratory Practices
Protection of Human Subjects
IRB
A drug will be considered adulterated and the responsible person is subject to regulatory action when
failing to comply with - Good Manufactoring Practices
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