SOCRA CCRP Investigational Product Management 1

Question 1

Who is primarily responsible for maintaining investigational product accountability records at a clinical trial site?

Accepted Answer

The principal investigator or designee

Answer

Under ICH GCP E6(R2), the principal investigator or their designee is responsible for maintaining accurate IP accountability records at the site.

Question 2

According to ICH GCP E6(R2), investigational products must be stored under conditions specified by:

Accepted Answer

The sponsor's protocol and investigational product information

Answer

ICH GCP requires IP to be stored according to conditions specified by the sponsor in the protocol or in the IP information provided to the site.

Question 3

What document is used at a clinical trial site to track all dispensing, administration, and returns of investigational product?

Accepted Answer

Investigational Product Accountability Log

Answer

The IP Accountability Log records all transactions involving investigational product, including receipt, dispensing, administration, and return or destruction.

Question 4

When an investigational product shipment is received at a clinical site, what is the FIRST action the site should take?

Accepted Answer

Inspect and document the shipment against the packing slip and protocol requirements

Answer

Upon receipt, the site must inspect the shipment for condition, quantity, and storage compliance and document findings against the packing slip.

Question 5

A temperature excursion is detected in the IP storage refrigerator over a weekend. What is the appropriate FIRST action?

Accepted Answer

Quarantine the affected IP and notify the sponsor

Answer

Affected IP must be quarantined and the sponsor notified so the sponsor can assess whether the product remains suitable for use.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Investigational Product Management 1