SOCRA CCRP Investigational Product Management 2

Question 1

What information is REQUIRED on the label of an investigational product intended for use in a clinical trial?

Accepted Answer

A statement that it is for investigational use only, protocol identification, and storage conditions

Answer

The commercial brand name and standard dosing instructions

Answer

The subject's home address and insurance information

Answer

The investigator's personal contact number

Question 2

In a double-blind, randomized controlled trial, who typically holds the randomization code to protect blinding integrity?

Accepted Answer

An unblinded third party such as the sponsor's statistician or an unblinded pharmacist

Answer

The principal investigator

Answer

The subject's primary care physician

Answer

The clinical research coordinator

Question 3

Under what circumstance is emergency unblinding of a subject's treatment assignment justified in a blinded clinical trial?

Accepted Answer

When knowledge of treatment is essential for the subject's medical management in a life-threatening emergency

Answer

When the sponsor's monitor requests it for data clarification

Answer

When the subject insists on knowing their treatment assignment

Answer

When the IRB requests it during a routine audit

Question 4

A subject accidentally takes double their prescribed dose of investigational product. What must the site do?

Accepted Answer

Document the error as a protocol deviation, assess for adverse effects, and report per protocol

Answer

Report this only in the final clinical study report

Answer

Disregard the event if no symptoms are observed

Answer

Immediately withdraw the subject without documentation

Question 5

Which GCP principle requires that investigational products be used only for purposes specified in the study protocol?

Accepted Answer

The principle of investigational product accountability and control

Answer

The principle of risk minimization

Answer

The principle of scientific validity

Answer

The principle of voluntary participation

Question 6

A sponsor requests that a site destroy excess investigational product on-site. What documentation is required?

Accepted Answer

A written destruction certificate signed by site personnel and witnessed

Answer

A verbal confirmation from the site pharmacist is sufficient

Answer

An email notification to the IRB

Answer

A separate IND amendment filed with FDA

Question 7

Which of the following is an IP accountability discrepancy that MUST be investigated at a clinical site?

Accepted Answer

A subject returning fewer unused tablets than expected based on dispensing records

Answer

A slight variation in tablet appearance between manufacturing lots

Answer

IP arriving one day later than the scheduled shipment date

Answer

A change in the investigational drug's commercial manufacturer name