CRA Medication Management Oversight 2

Question 1

Under 21 CFR Part 312, who is ultimately responsible for the proper conduct of an investigational drug study at a clinical site?

Accepted Answer

Principal Investigator

Answer

The Principal Investigator bears ultimate responsibility for the conduct of the study and proper use of investigational drugs at the site.

Question 2

A sponsor notices an investigational site is dispensing the study drug to subjects before receiving signed informed consent. This is primarily a violation of which regulation?

Accepted Answer

45 CFR Part 46

Answer

Administering investigational drugs before obtaining informed consent violates the human subjects protection requirements under 45 CFR Part 46.

Question 3

A research pharmacist discovers that temperature logs for a biologic study drug show two days of out-of-range storage. What is the most appropriate immediate action?

Accepted Answer

Quarantine the affected lot and notify the sponsor

Answer

Out-of-range storage requires quarantining the affected product and promptly notifying the sponsor for stability assessment.

Question 4

When a blinded randomized trial requires emergency unblinding for a participant, who should typically be contacted first?

Accepted Answer

The sponsor or designated emergency unblinding contact

Answer

Sponsors establish emergency unblinding procedures and should be contacted first through the designated 24-hour contact or code-break envelope process.

Question 5

Which document must be maintained to verify that all dispensed investigational drug quantities are accounted for at a clinical site?

Accepted Answer

Drug accountability log

Answer

The drug accountability log tracks dispensing, returns, and destruction, enabling reconciliation of all investigational product.

(CRA) Certified Research Administrator Practice Test

(CRA) Certified Research Administrator Practice Test

CRA Medication Management Oversight 2