Sample flash cards

Question 1

The purpose of disclosing financial information and interest in a particular clinical study is to support the FDA’s evaluation of marketing applications for drugs, biologics and devices.

True or False?

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True.

21 CFR 54.1

Question 1
Question 2

The term covered clinical study, as it relates to financial disclosure by investigators refers to all studies conducted in the US.

True or False?

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False.  The term covered clinical study includes only those studies being submitted to the FDA in a marketing application or reclassification petition that the FDA or applicant relies on to establish effectiveness.

21 CFR 54.2 

Question 2
Question 3

Sponsors of marketing applications submitted to the FDA are required to submit a list of all clinical investigators, who are full-time and part-time employees of the sponsor for each covered study.

True or False?

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True.

21 CFR 54.4 

Question 3
Question 4

The term significant equity interest in the sponsor of a covered study includes any ownership in stock or other financial interest that exceed $10,000.

True or False?

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False.  The includes amounts > $50,000 (US).

21 CFR 54.2 

Question 4
Question 5

Sponsors submitting marketing applications for drugs, biologics or devices are required to include Form FDA 3454, which attests to the absence of financial interests and arrangements for those investigators who provided such information to the sponsor.

True or False?

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True.

21 CFR 54.4.  

Question 5