SOCRA Investigational Product Management 3

Question 1

During a monitoring visit, the CRA finds that the drug accountability log shows 5 units dispensed but only 3 subject records document dispensing. What is this discrepancy called?

Accepted Answer

A drug accountability discrepancy requiring investigation

Answer

Any mismatch between IP dispensed per accountability records and subject-level documentation must be investigated and reconciled as a drug accountability discrepancy.

Question 2

Which of the following is the correct procedure when a blinded study requires IP dispensing?

Accepted Answer

The pharmacist or designee dispenses IP using the randomization code without unblinding the subject or investigator

Answer

In a blinded study, the pharmacist or designated unblinded individual dispenses IP per the randomization system while maintaining the blind for the investigator and subject.

Question 3

A subject returns partially used IP at a follow-up visit. What should the site do with the returned product?

Accepted Answer

Document the return in the accountability log, assess compliance, and store separately per protocol instructions

Answer

Returned IP must be logged, compliance assessed from the amount returned, and stored in a designated area per sponsor instructions until destruction or return to sponsor.

Question 4

What does 'IP reconciliation' refer to in the context of clinical trials?

Accepted Answer

Verifying that the total of IP received equals the sum of IP dispensed, returned, and destroyed

Answer

IP reconciliation confirms that received quantity = dispensed + returned + destroyed, ensuring full accounting of all investigational product at closeout.

Question 5

A sponsor requires that leftover IP be destroyed on-site. Which document must be completed to support this?

Accepted Answer

IP Destruction Record / Certificate of Destruction

Answer

A destruction record or certificate of destruction, signed by authorized site personnel, is required to document method, date, and quantity of IP destroyed on-site.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Investigational Product Management 3