SOCRA CCRP Investigational Product Management 3

Question 1

What is the purpose of investigational product reconciliation at the end of a clinical trial?

Accepted Answer

To verify that all IP received, dispensed, and returned or destroyed is fully accounted for

Answer

To confirm that IP costs were within the contracted study budget

Answer

To determine the residual commercial value of remaining IP

Answer

To prepare unused IP for future commercial marketing

Question 2

Who has authority to authorize continued use of investigational product that experienced a storage temperature excursion?

Accepted Answer

The sponsor, after evaluating the impact of the excursion on product quality

Answer

The principal investigator acting alone

Answer

The site's internal review board

Answer

The clinical research coordinator

Question 3

In a multi-site clinical trial, which document typically specifies how investigational product will be allocated and distributed to each participating site?

Accepted Answer

The IP Management Plan or drug supply plan provided by the sponsor

Answer

The site's standard operating procedures

Answer

The IRB approval letter for each site

Answer

The principal investigator's curriculum vitae

Question 4

When dispensing investigational product to a trial subject, which step is MOST critical to prevent medication errors?

Accepted Answer

Confirming the subject's randomization number, scheduled visit, and prescribed dose against the protocol

Answer

Verifying the subject's insurance coverage before dispensing

Answer

Having the sponsor monitor present during every dispensing event

Answer

Using only electronic dispensing systems approved by the sponsor

Question 5

What action should be taken if an investigational product lot is recalled by the sponsor during an ongoing clinical trial?

Accepted Answer

Immediately quarantine the recalled lot and follow sponsor instructions for return or destruction

Answer

Continue using the recalled lot until the current supply is exhausted

Answer

Inform subjects only if they specifically inquire about their treatment

Answer

Substitute the recalled lot with a commercially available equivalent

Question 6

Which U.S. federal regulation specifically governs the labeling requirements for investigational new drugs (INDs)?

Accepted Answer

21 CFR Part 312

Answer

21 CFR Part 11

Answer

21 CFR Part 50

Answer

21 CFR Part 56

Question 7

A CRC discovers that a subject was accidentally dispensed another subject's investigational product. What is the priority FIRST step?

Accepted Answer

Immediately assess the affected subject's safety and document the error as a protocol deviation and potential adverse event

Answer

Correct the dispensing record and continue the visit as normal

Answer

Notify the IRB and wait for written guidance before taking any action

Answer

Instruct the subject to return the IP without further investigation or documentation