CPI Investigational Product Management & Drug Accountability 3

Question 1

A site receives an investigational product that requires storage at room temperature (15°C–30°C). The site's storage room routinely reaches 32°C in summer. What should the investigator do?

Accepted Answer

Notify the sponsor, identify an appropriate storage area meeting specifications, and do not dispense product until compliant storage is confirmed

Answer

Store the product as-is and document the temperature in the accountability log

Answer

Place the product in the refrigerator as a precaution

Answer

Dispense the product immediately before temperature-related degradation occurs

Question 2

What is the purpose of randomization codes or the randomization list in a clinical trial?

Accepted Answer

To assign subjects to treatment arms in an unpredictable manner to minimize selection bias

Answer

To prioritize enrollment of subjects with the most severe disease

Answer

To rank subjects by likelihood of completing the study

Answer

To determine which subjects will receive placebo based on insurance coverage

Question 3

During an FDA inspection, an investigator is asked to produce documentation that IP was stored under appropriate conditions throughout the trial. Which record is most directly responsive to this request?

Accepted Answer

The continuous temperature monitoring logs for the IP storage area

Answer

The signed informed consent forms

Answer

The subject screening and enrollment log

Answer

The IRB correspondence file

Question 4

A subject in a blinded study takes twice the prescribed dose for one week due to a misunderstanding. Under drug accountability principles, how should this be handled?

Accepted Answer

Document the protocol deviation, record the quantity consumed in the accountability log, assess for safety implications, and notify the sponsor and IRB as required

Answer

Ignore the event since the subject self-reported and no harm occurred

Answer

Withdraw the subject without documentation to protect their privacy

Answer

Adjust future dispensing quantities upward to compensate for the overuse

Question 5

What is a 'comparator drug' in the context of investigational product management?

Accepted Answer

An approved or investigational drug used as a control or reference treatment against which the experimental drug is evaluated

Answer

A drug used exclusively to treat adverse events during the trial

Answer

A second investigational product taken simultaneously with the primary study drug

Answer

A marketed drug repurposed for an unapproved indication without an IND

Question 6

Which of the following scenarios represents a serious breach of investigational product accountability that must be reported to the sponsor immediately?

Accepted Answer

Investigational product is discovered missing from site inventory with no documentation explaining the loss

Answer

A minor typographical error on a dispensing log corrected with a single strikethrough and initials

Answer

A one-day delay in completing a drug return due to a site holiday

Answer

A subject returns 1 more tablet than expected due to a missed dose

Question 7

When a clinical trial is terminated early, which statement regarding investigational product management is correct?

Accepted Answer

IP reconciliation and final disposition (return or destruction per sponsor instructions) must be completed even though the trial ended early

Answer

The investigator may retain unused IP for future investigational use without sponsor approval

Answer

Only IP dispensed to subjects requires accountability; remaining stock can be discarded without documentation

Answer

Drug accountability records can be destroyed immediately once the termination notice is signed