Investigational Product Management Flashcards

When investigational product (IP) is received at a clinical site, what is the FIRST action the site coordinator should take?

Answer: Inspect the shipment and verify contents against the packing list and shipping manifest

Upon receipt, the site must inspect the shipment for integrity, verify contents against documentation, and check temperature monitoring devices before accepting the shipment.

A temperature excursion is discovered after IP has been stored at the site for two weeks. What should the CRC do?

Answer: Quarantine the affected IP and notify the sponsor immediately for guidance

Affected IP must be quarantined and the sponsor notified immediately; only the sponsor can determine whether the product remains suitable for use.

Which document specifically tracks the movement of investigational product from the manufacturer to the investigator site?

Answer: Chain of Custody / Shipping manifest

The chain of custody or shipping manifest documents the transfer of IP from origin to destination, ensuring accountability at every step.

An investigational drug requires storage at 2–8°C. The site refrigerator maximum alarm was triggered over a weekend. What is the appropriate response?

Answer: Document the excursion, quarantine affected IP, and contact the sponsor for disposition instructions

Any temperature excursion must be documented and reported to the sponsor, and IP must be quarantined pending sponsor evaluation of product integrity.

Under ICH E6(R2), who is responsible for ensuring that investigational product at the site is stored according to protocol specifications?

Answer: The Principal Investigator

The Principal Investigator is responsible for ensuring proper storage and handling of IP at the clinical site per ICH E6(R2) Section 4.6.

What is the purpose of a drug accountability log in a clinical trial?

Answer: To record all IP received, dispensed, returned, and destroyed at the site

The drug accountability log provides a complete inventory record of IP movement, enabling reconciliation and regulatory compliance verification.

A site receives IP with a label stating 'For Investigational Use Only — Not for Sale.' This labeling requirement is mandated by which regulation?

Answer: 21 CFR Part 312.6

21 CFR Part 312.6 requires that investigational new drug products bear labels stating 'Caution: New Drug—Limited by Federal (or United States) law to investigational use.'