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

To calculate the sponsor's manufacturing costs

Answer

To track IP shipment transit times

Answer

To monitor competitive product use by subjects

Question 2

A 'temperature excursion' for investigational product occurs when:

Accepted Answer

IP storage conditions deviate outside the protocol-specified temperature range

Answer

The IP is shipped to an unapproved country

Answer

The IP dispensing log shows missing entries

Answer

The IP expiration date passes without disposal

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

Any site staff member listed on the trial team list

Answer

The CRA during monitoring visits

Answer

Any licensed pharmacist regardless of trial training

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

Destroy the excess IP immediately

Answer

Assume it is a counting error and move on

Answer

Report the site to the FDA immediately

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

Allow site coordinators to optimize treatment allocation

Answer

Reduce the number of placebo-assigned subjects

Answer

Ensure balanced age distribution across treatment arms

Question 6

When investigational product is returned from a site for destruction, the CRA must confirm:

Accepted Answer

All returned IP is properly labeled, logged, and accompanied by documentation confirming quantities and condition

Answer

The site has purchased replacement supplies

Answer

The returned IP is tested for potency before destruction

Answer

The subjects who used the IP have signed an additional consent