SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Investigational Product Management 1

Question 1

Which document must accompany each shipment of investigational product received at a clinical site?

Accepted Answer

A shipping manifest or drug receipt log signed by the investigator

Answer

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?

Accepted Answer

To ensure that every unit of IP received can be accounted for through dispensing, return, or destruction records

Answer

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?

Accepted Answer

Quarantine the affected IP and notify the sponsor before using or dispensing it

Answer

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?

Accepted Answer

The principal investigator (PI)

Answer

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?

Accepted Answer

A statement identifying the product as investigational, the protocol number, and storage conditions at minimum

Answer

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.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Investigational Product Management 1