CTA Investigational Product Management 2 — Questions and Answers
Question 1: What is the correct action when investigational product at a site reaches its expiration date?
- Continue using it until the current supply is exhausted to avoid waste
- Obtain written sponsor authorization to use it beyond the expiration date
- Quarantine the expired product, notify the sponsor, and arrange disposal per protocol (Correct answer)
- Return it immediately to the manufacturer for relabeling
Correct answer: Quarantine the expired product, notify the sponsor, and arrange disposal per protocol
Expired IP must be quarantined and removed from use immediately; the sponsor must be notified and disposal must follow the protocol's or sponsor's destruction instructions.
Question 2: What is a drug destruction certificate in the context of clinical trials?
- A laboratory report confirming drug potency has degraded below acceptable levels
- An official document certifying that unused or expired IP was destroyed per regulatory requirements (Correct answer)
- A sponsor invoice for the cost of destroyed investigational product
- An IRB form approving the early termination of drug administration
Correct answer: An official document certifying that unused or expired IP was destroyed per regulatory requirements
A drug destruction certificate documents that unused or expired investigational product was destroyed in accordance with applicable regulations and sponsor instructions, completing the accountability chain.
Question 3: How should a temperature excursion affecting investigational product be handled at a clinical trial site?
- Discard all affected product and reorder without notifying anyone
- Continue using the product if it looks and smells normal
- Document the excursion, quarantine the affected product, and notify the sponsor for disposition guidance (Correct answer)
- Immediately dispense all affected product to enrolled participants before it degrades further
Correct answer: Document the excursion, quarantine the affected product, and notify the sponsor for disposition guidance
Any temperature excursion must be documented and the affected product quarantined; the sponsor must be notified to evaluate whether the IP is still suitable for use or must be destroyed.
Question 4: What is the primary purpose of a drug accountability binder maintained at a clinical trial site?
- To store participant medical records alongside dispensing records
- To provide a centralized, auditable record of all IP transactions including receipts, dispensing, returns, and destruction (Correct answer)
- To record financial payments made to participants for study drug costs
- To file the sponsor's investigational new drug application supporting documents
Correct answer: To provide a centralized, auditable record of all IP transactions including receipts, dispensing, returns, and destruction
The drug accountability binder consolidates all IP transaction records in one location, enabling auditors and monitors to verify that all product is fully accounted for throughout the trial.
Question 5: Who must authorize any changes to investigational product storage conditions at a clinical trial site?
- The site's principal investigator acting alone
- The CTA or study coordinator managing daily operations
- The sponsor or designee, typically in writing before implementation (Correct answer)
- The local pharmacy board in the state where the site is located
Correct answer: The sponsor or designee, typically in writing before implementation
Storage condition changes must be pre-approved by the sponsor in writing because the sponsor is responsible for maintaining IP quality and any deviation requires formal authorization to ensure regulatory compliance.
Question 6: What is 'unblinding' and under what circumstance is it permitted during a clinical trial?
- Revealing all participants' treatment assignments to the IRB at study midpoint for safety review
- Revealing a specific participant's treatment assignment, typically only in a medical emergency requiring knowledge of treatment to guide care (Correct answer)
- Disclosing the IP formula to site staff after the last participant is enrolled
- Opening blinded data packages when the sponsor requests interim analysis
Correct answer: Revealing a specific participant's treatment assignment, typically only in a medical emergency requiring knowledge of treatment to guide care
Unblinding is the disclosure of a participant's treatment assignment and is only permitted in a genuine medical emergency where the treating physician needs treatment information to manage the participant's care.
Question 7: According to GCP, how frequently should a clinical monitor verify IP accountability records at the site?
- Only at the closeout visit at the end of the study
- Annually, regardless of study visit frequency
- During each monitoring visit throughout the study (Correct answer)
- Only when the site reports a protocol deviation
Correct answer: During each monitoring visit throughout the study
GCP E6 requires monitors to verify IP accountability records at each monitoring visit to detect discrepancies early and ensure ongoing compliance with storage and dispensing requirements.
CTA Investigational Product Management 2
What is the correct action when investigational product at a site reaches its expiration date?