CPI Patient Assessment & Evaluation 3

Question 1

According to CTCAE v5.0, a subject experiences alanine aminotransferase (ALT) elevation at 4 times the upper limit of normal (ULN) with no symptoms. This represents which grade of adverse event?

Accepted Answer

Grade 3

Answer

CTCAE Grade 3 for ALT elevation is defined as >3.0–20x ULN, so a 4x ULN elevation falls within Grade 3.

Question 2

A subject enrolled in a renal oncology trial has an eGFR of 28 mL/min/1.73m². The protocol requires eGFR ≥30 mL/min/1.73m² for continued participation. What action is required?

Accepted Answer

Discontinue the investigational product and notify the sponsor per protocol

Answer

A laboratory value that no longer meets a protocol-required threshold typically mandates discontinuation of the investigational product and sponsor notification per the protocol-specified procedures.

Question 3

At a routine study visit, a subject's blood pressure reads 178/104 mmHg. The subject feels well and has no symptoms. As the investigator, what is the FIRST priority?

Accepted Answer

Assess the subject clinically, determine if intervention is needed, and document findings

Answer

The investigator's first priority is always subject safety: assess the clinical situation, determine need for intervention, and then document findings and any protocol-required actions.

Question 4

A 12-lead ECG performed at screening shows sinus bradycardia with a heart rate of 52 bpm. The protocol excludes subjects with HR <50 bpm. How should this finding be handled?

Accepted Answer

Enroll the subject because HR of 52 meets the protocol threshold of >50 bpm

Answer

A heart rate of 52 bpm exceeds the exclusion threshold of <50 bpm, so the subject meets this ECG criterion for enrollment.

Question 5

Hepatic function assessment in a clinical trial typically includes which combination of laboratory tests?

Accepted Answer

ALT, AST, alkaline phosphatase, and total bilirubin

Answer

Hepatic function is assessed with liver enzymes (ALT, AST, ALP) and total bilirubin, which together reflect hepatocellular damage and biliary function.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Patient Assessment & Evaluation 3