CCRA Investigational Product Management

Question 1

What is the purpose of investigational product (IP) accountability at a clinical trial site?

Accepted Answer

To ensure accurate records of all IP received, dispensed, returned, and destroyed to verify subject compliance and prevent misuse

Answer

IP accountability requires maintaining records showing the disposition of every unit of investigational product to confirm it was used only for trial purposes and that subjects received the correct doses.

Question 2

A 'temperature excursion' for investigational product occurs when:

Accepted Answer

IP storage conditions deviate outside the protocol-specified temperature range

Answer

A temperature excursion is when IP is exposed to temperatures outside the specified storage range; the sponsor's medical/quality team must evaluate whether the affected IP remains usable.

Question 3

Who is authorized to dispense investigational product at a clinical trial site?

Accepted Answer

Only qualified personnel delegated and documented on the Delegation of Authority Log, typically the pharmacist or designated nurse/coordinator

Answer

Only personnel specifically trained and authorized on the site's Delegation of Authority Log may dispense IP; this typically requires trial-specific training and pharmacy or nursing qualifications.

Question 4

During IP reconciliation at a monitoring visit, the CRA discovers more units were dispensed than accounted for in subject dosing records. The FIRST action is to:

Accepted Answer

Investigate the discrepancy with site staff and document findings; notify the sponsor if unresolved

Answer

IP discrepancies must be investigated with site staff to identify the cause; if unexplained, the sponsor must be notified, and depending on severity, regulatory reporting or a for-cause audit may be required.

Question 5

The 'randomization code' in a blinded clinical trial is maintained to:

Accepted Answer

Enable emergency unblinding for subject safety and final unblinding for statistical analysis

Answer

Randomization codes are securely maintained so they can be accessed in emergencies (e.g., to determine treatment for safety management) and at study end for statistical analysis.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Investigational Product Management