SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Investigational Product Management 1 — Questions and Answers
Question 1: Which document must accompany each shipment of investigational product received at a clinical site?
- The site's IRB approval letter
- A shipping manifest or drug receipt log signed by the investigator (Correct answer)
- The sponsor's financial disclosure form
- A packing slip verified by the site's billing department
Correct answer: A shipping manifest or drug receipt log signed by the investigator
Every IP shipment must be documented with a drug receipt log or shipping manifest that captures quantity received, lot number, expiration date, and storage condition on arrival. This record is signed by an authorized site representative, typically the investigator or designated staff, to establish the chain of custody.
Question 2: What is the primary purpose of IP reconciliation at a clinical site?
- To calculate the cost of the study drug for reimbursement
- To ensure that every unit of IP received can be accounted for through dispensing, return, or destruction records (Correct answer)
- To verify that the investigator's brochure matches the product label
- To confirm that the site's pharmacy license is current
Correct answer: To ensure that every unit of IP received can be accounted for through dispensing, return, or destruction records
IP reconciliation verifies that the sum of units dispensed, returned unused, and destroyed equals the total units received. A complete reconciliation with no unexplained discrepancies is required by regulations and sponsor audits to demonstrate that no IP was diverted or misused.
Question 3: When a temperature excursion is discovered for stored investigational product, what is the correct immediate action?
- Discard the affected IP immediately to prevent protocol deviations
- Continue using the IP if it looks and smells normal
- Quarantine the affected IP and notify the sponsor before using or dispensing it (Correct answer)
- Report the excursion only at the next monitoring visit
Correct answer: Quarantine the affected IP and notify the sponsor before using or dispensing it
Upon discovering a temperature excursion, the site must immediately quarantine the affected IP so it cannot be accidentally dispensed. The sponsor must be notified promptly because only the sponsor—or their designee—can evaluate stability data and determine whether the affected product is still acceptable for use.
Question 4: Who is ultimately responsible for ensuring that investigational product at a clinical site is handled, stored, and dispensed in accordance with the protocol?
- The sponsor's clinical research associate (CRA)
- The site's IRB or ethics committee
- The principal investigator (PI) (Correct answer)
- The hospital pharmacy director
Correct answer: The principal investigator (PI)
Under ICH E6 GCP, the principal investigator bears ultimate responsibility for all investigational product management at the site, including storage, dispensing, and record-keeping. The PI may delegate specific tasks to qualified staff, but accountability cannot be delegated away.
Question 5: What information is required on the label of an investigational product supplied to a clinical site?
- The retail price and insurance billing code
- The sponsor's trade name and marketing authorization number
- A statement identifying the product as investigational, the protocol number, and storage conditions at minimum (Correct answer)
- The subject's full name and home address
Correct answer: A statement identifying the product as investigational, the protocol number, and storage conditions at minimum
Regulatory requirements (21 CFR 312.6; ICH E6) mandate that IP labels include a statement such as 'Caution: New Drug—Limited by Federal Law to Investigational Use,' the protocol number, and required storage conditions. Labels must not identify the blinded treatment in masked studies.
Question 6: Under what circumstance may a clinical site destroy investigational product on-site rather than returning it to the sponsor?
- Whenever the site pharmacist determines the product has expired
- Only when explicitly authorized in writing by the sponsor and in compliance with applicable regulations (Correct answer)
- Any time the site's storage capacity is insufficient to hold returned materials
- When the study has been closed for more than 30 days
Correct answer: Only when explicitly authorized in writing by the sponsor and in compliance with applicable regulations
On-site destruction of IP is only permissible when the sponsor has provided written authorization and the destruction meets all applicable local, state, and federal regulations for hazardous or pharmaceutical waste. Destruction must be fully documented, including method, quantity, and the signature of the person who performed or witnessed it.
SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Investigational Product Management 1
Which document must accompany each shipment of investigational product received at a clinical site?