Investigational Product Management Flashcards

What is the purpose of investigational product (IP) accountability at a clinical trial site?

Answer: To ensure accurate records of all IP received, dispensed, returned, and destroyed to verify subject compliance and prevent misuse

IP accountability requires maintaining records showing the disposition of every unit of investigational product to confirm it was used only for trial purposes and that subjects received the correct doses.

A 'temperature excursion' for investigational product occurs when:

Answer: IP storage conditions deviate outside the protocol-specified temperature range

A temperature excursion is when IP is exposed to temperatures outside the specified storage range; the sponsor's medical/quality team must evaluate whether the affected IP remains usable.

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

Answer: Only qualified personnel delegated and documented on the Delegation of Authority Log, typically the pharmacist or designated nurse/coordinator

Only personnel specifically trained and authorized on the site's Delegation of Authority Log may dispense IP; this typically requires trial-specific training and pharmacy or nursing qualifications.

During IP reconciliation at a monitoring visit, the CRA discovers more units were dispensed than accounted for in subject dosing records. The FIRST action is to:

Answer: Investigate the discrepancy with site staff and document findings; notify the sponsor if unresolved

IP discrepancies must be investigated with site staff to identify the cause; if unexplained, the sponsor must be notified, and depending on severity, regulatory reporting or a for-cause audit may be required.

The 'randomization code' in a blinded clinical trial is maintained to:

Answer: Enable emergency unblinding for subject safety and final unblinding for statistical analysis

Randomization codes are securely maintained so they can be accessed in emergencies (e.g., to determine treatment for safety management) and at study end for statistical analysis.

When investigational product is returned from a site for destruction, the CRA must confirm:

Answer: All returned IP is properly labeled, logged, and accompanied by documentation confirming quantities and condition

Returned IP must be documented with quantities matching records, properly labeled, and accompanied by return authorization documentation; this ensures full accountability and proper destruction.