CTA Investigational Product Management 2

Question 1

What is the correct action when investigational product at a site reaches its expiration date?

Accepted Answer

Quarantine the expired product, notify the sponsor, and arrange disposal per protocol

Answer

Continue using it until the current supply is exhausted to avoid waste

Answer

Obtain written sponsor authorization to use it beyond the expiration date

Answer

Return it immediately to the manufacturer for relabeling

Question 2

What is a drug destruction certificate in the context of clinical trials?

Accepted Answer

An official document certifying that unused or expired IP was destroyed per regulatory requirements

Answer

A laboratory report confirming drug potency has degraded below acceptable levels

Answer

A sponsor invoice for the cost of destroyed investigational product

Answer

An IRB form approving the early termination of drug administration

Question 3

How should a temperature excursion affecting investigational product be handled at a clinical trial site?

Accepted Answer

Document the excursion, quarantine the affected product, and notify the sponsor for disposition guidance

Answer

Discard all affected product and reorder without notifying anyone

Answer

Continue using the product if it looks and smells normal

Answer

Immediately dispense all affected product to enrolled participants before it degrades further

Question 4

What is the primary purpose of a drug accountability binder maintained at a clinical trial site?

Accepted Answer

To provide a centralized, auditable record of all IP transactions including receipts, dispensing, returns, and destruction

Answer

To store participant medical records alongside dispensing records

Answer

To record financial payments made to participants for study drug costs

Answer

To file the sponsor's investigational new drug application supporting documents

Question 5

Who must authorize any changes to investigational product storage conditions at a clinical trial site?

Accepted Answer

The sponsor or designee, typically in writing before implementation

Answer

The site's principal investigator acting alone

Answer

The CTA or study coordinator managing daily operations

Answer

The local pharmacy board in the state where the site is located

Question 6

What is 'unblinding' and under what circumstance is it permitted during a clinical trial?

Accepted Answer

Revealing a specific participant's treatment assignment, typically only in a medical emergency requiring knowledge of treatment to guide care

Answer

Revealing all participants' treatment assignments to the IRB at study midpoint for safety review

Answer

Disclosing the IP formula to site staff after the last participant is enrolled

Answer

Opening blinded data packages when the sponsor requests interim analysis

Question 7

According to GCP, how frequently should a clinical monitor verify IP accountability records at the site?

Accepted Answer

During each monitoring visit throughout the study

Answer

Only at the closeout visit at the end of the study

Answer

Annually, regardless of study visit frequency

Answer

Only when the site reports a protocol deviation