CRA Investigational Product Management 1

Question 1

What document must be maintained at a clinical site to track the receipt, dispensing, and return or destruction of investigational product?

Accepted Answer

Drug Accountability Log

Answer

The Drug Accountability Log tracks all investigational product movements including receipt, dispensing to subjects, returns, and destruction to ensure complete accountability.

Question 2

Which temperature range is defined as 'controlled room temperature' per USP standards for investigational product storage?

Accepted Answer

15°C to 30°C

Answer

USP defines controlled room temperature as 15°C to 30°C (59°F to 86°F), which is the standard for products requiring room temperature storage.

Question 3

Who bears ultimate responsibility for the proper use, storage, and accountability of investigational product at a clinical site?

Accepted Answer

The Principal Investigator

Answer

The Principal Investigator bears ultimate responsibility for all trial activities at the site, including proper handling and accountability of investigational product.

Question 4

What should a CRA do upon discovering a temperature excursion in the investigational product storage area during a monitoring visit?

Accepted Answer

Document the excursion and notify the sponsor for product integrity assessment

Answer

Temperature excursions must be documented and reported to the sponsor, who will assess product integrity and provide guidance on whether the affected product can continue to be used.

Question 5

In a double-blind clinical trial, what is the key requirement for investigational product labeling?

Accepted Answer

Labels must not reveal whether the product is active drug or placebo

Answer

Double-blind trial labeling must be coded so neither the subject nor the investigator can determine whether the product is active drug or placebo, preserving the blind.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA Investigational Product Management 1