SOCRA Investigational Product Management 2 — Questions and Answers
Question 1: When investigational product (IP) is received at a clinical site, what is the FIRST action the site coordinator should take?
- Immediately dispense IP to enrolled subjects
- Inspect the shipment and verify contents against the packing list and shipping manifest (Correct answer)
- File the shipping documents without opening the package
- Notify the IRB of the IP receipt
Correct 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.
Question 2: A temperature excursion is discovered after IP has been stored at the site for two weeks. What should the CRC do?
- Discard the IP immediately and reorder
- Continue using the IP since two weeks have passed without incident
- Quarantine the affected IP and notify the sponsor immediately for guidance (Correct answer)
- Dispense remaining IP before reporting the excursion
Correct 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.
Question 3: Which document specifically tracks the movement of investigational product from the manufacturer to the investigator site?
- Investigator Brochure
- Chain of Custody / Shipping manifest (Correct answer)
- Protocol amendment
- Informed consent form
Correct 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.
Question 4: An investigational drug requires storage at 2–8°C. The site refrigerator maximum alarm was triggered over a weekend. What is the appropriate response?
- Reset the alarm and continue using the IP
- Document the excursion, quarantine affected IP, and contact the sponsor for disposition instructions (Correct answer)
- Move the IP to a staff member's home refrigerator
- Use the IP within 24 hours to avoid waste
Correct 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.
Question 5: Under ICH E6(R2), who is responsible for ensuring that investigational product at the site is stored according to protocol specifications?
- The IRB/IEC
- The Sponsor only
- The Principal Investigator (Correct answer)
- The contract research organization's monitor
Correct 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.
Question 6: What is the purpose of a drug accountability log in a clinical trial?
- To track subject adverse events related to the study drug
- To record all IP received, dispensed, returned, and destroyed at the site (Correct answer)
- To document pharmacy staff credentials
- To summarize IP costs for budget reconciliation
Correct 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.
Question 7: A site receives IP with a label stating 'For Investigational Use Only — Not for Sale.' This labeling requirement is mandated by which regulation?
- 21 CFR Part 50
- 21 CFR Part 312.6 (Correct answer)
- 21 CFR Part 56
- ICH E8
Correct 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.'
SOCRA Investigational Product Management 2
When investigational product (IP) is received at a clinical site, what is the FIRST action the site coordinator should take?