Practice Test Geeks(CPI) Certified Physician Investigator Practice Test
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Patient Assessment & Evaluation Flashcards

7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Patient Assessment & Evaluation flashcards as text

  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?

    Answer: Grade 3

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

  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?

    Answer: Discontinue the investigational product and notify the sponsor per protocol

    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.

  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?

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

    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.

  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?

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

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

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

    Answer: ALT, AST, alkaline phosphatase, and total bilirubin

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

  6. A subject reports taking St. John's Wort herbal supplement daily. Why is this significant during patient assessment in a clinical trial?

    Answer: St. John's Wort is a potent CYP3A4 inducer that can alter investigational drug metabolism

    St. John's Wort strongly induces CYP3A4 enzymes, which can significantly reduce plasma levels of many investigational drugs and compromise efficacy or safety assessments.

  7. A subject's creatinine clearance is calculated using the Cockcroft-Gault formula. Which variables are required for this calculation?

    Answer: Age, weight, sex, and serum creatinine

    The Cockcroft-Gault formula requires age, body weight, sex (correction factor of 0.85 for females), and serum creatinine to estimate creatinine clearance.