CRA Investigational Product Management 2

Question 1

What is an 'emergency code break' in the context of a blinded clinical trial?

Accepted Answer

Unblinding a subject's treatment assignment for medical management

Answer

Forcing open a locked pharmacy cabinet during an emergency

Answer

Accessing a restricted site after hours during a regulatory audit

Answer

Overriding an EDC system lockout to enter missing data

Question 2

How must unused investigational product typically be handled at study close-out?

Accepted Answer

Returned to the sponsor or destroyed per sponsor instructions with full documentation

Answer

Discarded in the site's regular medical waste

Answer

Retained by the site indefinitely for future reference

Answer

Donated to unrelated patients at the investigator's discretion

Question 3

What is the primary purpose of a kit number or bottle number on investigational product in a blinded study?

Accepted Answer

To uniquely identify and track each unit of IP while maintaining blinding

Answer

To identify the product for financial billing purposes

Answer

To indicate the subject's insurance and eligibility information

Answer

To specify the investigator's DEA registration number on each unit

Question 4

Which US regulation establishes requirements for investigational drug storage, handling, and accountability at clinical trial sites?

Accepted Answer

21 CFR Part 312

Answer

ICH E6 guidelines only

Answer

21 CFR Part 50

Answer

FDA Guidance for Industry on IRB Review

Question 5

What should a site do upon receiving investigational product with visibly damaged or compromised packaging?

Accepted Answer

Document the damage, quarantine the product, and notify the sponsor

Answer

Accept the shipment and begin dispensing immediately

Answer

Return the product without creating any documentation

Answer

Dispose of the product at the site's discretion without contacting the sponsor

Question 6

Per 21 CFR Part 312, what is the minimum retention period for drug accountability records after a study is completed?

Accepted Answer

2 years after marketing approval or 2 years after the IND is discontinued

Answer

1 year after study completion

Answer

6 months after the last subject visit

Answer

Until the next scheduled monitoring visit

Question 7

Who is authorized to dispense investigational product to study subjects at a clinical trial site?

Accepted Answer

Only authorized pharmacy or designated licensed personnel per site SOPs and protocol

Answer

Any site staff member who has completed GCP training

Answer

Only the Principal Investigator personally for each subject

Answer

The sponsor's CRA during on-site monitoring visits