CPI Patient Assessment & Evaluation 2

Question 1

A clinical trial requires an ECOG Performance Status of 0-2 for enrollment. A candidate who is ambulatory and capable of all self-care but unable to carry out any work activities has an ECOG score of:

Accepted Answer

2

Answer

ECOG PS 2 describes a patient who is ambulatory and capable of all self-care but unable to perform work activities, up and about more than 50% of waking hours.

Question 2

During screening, a subject's medical history reveals they completed chemotherapy 6 weeks ago. The protocol requires a 4-week washout for prior chemotherapy. What is the correct action?

Accepted Answer

Enroll the subject immediately since 6 weeks exceeds the washout period

Answer

The subject completed chemotherapy 6 weeks ago, which exceeds the required 4-week washout period, making them eligible based on this criterion.

Question 3

Which element of a patient's medical history is MOST critical to document during clinical trial screening to assess eligibility?

Accepted Answer

All prior and concomitant medications, diagnoses, procedures, and allergies

Answer

A complete medical history including all prior/concomitant medications, diagnoses, procedures, and allergies is essential to evaluate inclusion/exclusion criteria and potential drug interactions.

Question 4

A protocol mandates collection of concomitant medications at every study visit. A subject starts a new over-the-counter NSAID between visits. When should this be documented?

Accepted Answer

At the earliest opportunity, such as a phone call or unscheduled visit

Answer

Concomitant medications should be documented as soon as they are reported to ensure accurate safety data capture and assessment of potential protocol deviations.

Question 5

A female subject of childbearing potential is being screened for a clinical trial involving a teratogenic investigational drug. Which pregnancy test result is required before enrollment?

Accepted Answer

A negative serum or urine pregnancy test within the timeframe specified in the protocol

Answer

Protocols involving teratogenic agents require a documented negative pregnancy test within the protocol-specified window (typically 24-72 hours before enrollment) to confirm eligibility.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Patient Assessment & Evaluation 2