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

Before dispensing, the site must ensure IP is stored per protocol specifications; exceeding the allowed temperature range requires sponsor notification and resolution of the storage issue before any product is used.

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

Randomization assigns subjects to treatment groups in an unpredictable, unbiased way, ensuring that known and unknown confounders are evenly distributed across groups.

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

Continuous temperature monitoring logs provide a verifiable record that IP storage conditions remained within protocol-specified ranges for the duration of the study.

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

Overdosing constitutes a protocol deviation that must be documented in both the accountability records and the subject's study file, with safety assessment and sponsor/IRB notification per protocol requirements.

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 comparator drug is an approved or investigational product used as an active control or reference arm so the experimental drug's effects can be evaluated relative to an established treatment.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Investigational Product Management & Drug Accountability 3