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

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

The sponsor or designee, typically in writing before implementation

Answer

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.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Investigational Product Management 2