CRA Investigational Product Management 2 — Questions and Answers
Question 1: What is an 'emergency code break' in the context of a blinded clinical trial?
- Forcing open a locked pharmacy cabinet during an emergency
- Unblinding a subject's treatment assignment for medical management (Correct answer)
- Accessing a restricted site after hours during a regulatory audit
- Overriding an EDC system lockout to enter missing data
Correct answer: Unblinding a subject's treatment assignment for medical management
An emergency code break is the formal process of revealing a blinded subject's treatment assignment when it is medically necessary for the care of that subject.
Question 2: How must unused investigational product typically be handled at study close-out?
- Discarded in the site's regular medical waste
- Returned to the sponsor or destroyed per sponsor instructions with full documentation (Correct answer)
- Retained by the site indefinitely for future reference
- Donated to unrelated patients at the investigator's discretion
Correct answer: Returned to the sponsor or destroyed per sponsor instructions with full documentation
Unused investigational product must be returned to the sponsor or destroyed per sponsor-approved procedures, with complete documentation of all dispositions.
Question 3: What is the primary purpose of a kit number or bottle number on investigational product in a blinded study?
- To identify the product for financial billing purposes
- To uniquely identify and track each unit of IP while maintaining blinding (Correct answer)
- To indicate the subject's insurance and eligibility information
- To specify the investigator's DEA registration number on each unit
Correct answer: To uniquely identify and track each unit of IP while maintaining blinding
Kit and bottle numbers uniquely identify each unit of investigational product, enabling full accountability and tracking without revealing the treatment assignment in blinded studies.
Question 4: Which US regulation establishes requirements for investigational drug storage, handling, and accountability at clinical trial sites?
- ICH E6 guidelines only
- 21 CFR Part 312 (Correct answer)
- 21 CFR Part 50
- FDA Guidance for Industry on IRB Review
Correct answer: 21 CFR Part 312
21 CFR Part 312, which governs Investigational New Drug applications, establishes the US regulatory requirements for investigational drug storage, handling, and accountability.
Question 5: What should a site do upon receiving investigational product with visibly damaged or compromised packaging?
- Accept the shipment and begin dispensing immediately
- Document the damage, quarantine the product, and notify the sponsor (Correct answer)
- Return the product without creating any documentation
- Dispose of the product at the site's discretion without contacting the sponsor
Correct answer: Document the damage, quarantine the product, and notify the sponsor
Damaged product must be quarantined to prevent its use, the damage documented, and the sponsor notified so they can assess product integrity before any decision is made.
Question 6: Per 21 CFR Part 312, what is the minimum retention period for drug accountability records after a study is completed?
- 1 year after study completion
- 2 years after marketing approval or 2 years after the IND is discontinued (Correct answer)
- 6 months after the last subject visit
- Until the next scheduled monitoring visit
Correct answer: 2 years after marketing approval or 2 years after the IND is discontinued
Per 21 CFR 312.62, drug accountability records must be retained for 2 years after marketing approval of the drug or 2 years after the IND is discontinued.
Question 7: Who is authorized to dispense investigational product to study subjects at a clinical trial site?
- Any site staff member who has completed GCP training
- Only authorized pharmacy or designated licensed personnel per site SOPs and protocol (Correct answer)
- Only the Principal Investigator personally for each subject
- The sponsor's CRA during on-site monitoring visits
Correct answer: Only authorized pharmacy or designated licensed personnel per site SOPs and protocol
Dispensing of investigational product must be performed only by formally authorized personnel, typically a licensed pharmacist or designee, as specified in site SOPs and the protocol.
CRA Investigational Product Management 2
What is an 'emergency code break' in the context of a blinded clinical trial?