Quiz: Investigational New Drugs

1

If a drug has never been tested in humans before and the goal of the initial study is to establish the safety and pharmacokinetics of a single ascending dose in healthy subjects, this study is considered a _____ study.

A. Phase 1

B. Phase 2

C. Phase 3

D. Phase 4

2

A Sponsor of a clinical trial is responsible for many aspects of clinical trial conduct, which includes:

A. Maintaining the clinical trial master file.

B. Supplying and disposing of Investigational Drug.

C. Ensuring the Investigators are conducting the trial according to the protocol.

D. A, B, and C.

3

Behavioral studies involving patients taking approved drugs may, in some cases, be exempt from the requirements to submit an IND.

A. TRUE

B. FALSE

4

To obtain a notice of exemption of IND requirements from the FDA for a particular clinical study, the sponsor of the potential IND should:

A. Submit the IND application and wait 30 days for FDA review.

B. Submit a notice to FDA that the study is IND exempt and then start the study.

C. Submit the protocol to the IRB for review.

D. Submit Form FDA1572 to FDA.

5

An investigational drug cannot be a controlled substance as it is not yet approved for sale.

A. TRUE

B. FALSE