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
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:
Answer: 2
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.
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?
Answer: Enroll the subject immediately since 6 weeks exceeds the washout period
The subject completed chemotherapy 6 weeks ago, which exceeds the required 4-week washout period, making them eligible based on this criterion.
Which element of a patient's medical history is MOST critical to document during clinical trial screening to assess eligibility?
Answer: All prior and concomitant medications, diagnoses, procedures, and allergies
A complete medical history including all prior/concomitant medications, diagnoses, procedures, and allergies is essential to evaluate inclusion/exclusion criteria and potential drug interactions.
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?
Answer: At the earliest opportunity, such as a phone call or unscheduled visit
Concomitant medications should be documented as soon as they are reported to ensure accurate safety data capture and assessment of potential protocol deviations.
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?
Answer: A negative serum or urine pregnancy test within the timeframe specified in the protocol
Protocols involving teratogenic agents require a documented negative pregnancy test within the protocol-specified window (typically 24-72 hours before enrollment) to confirm eligibility.
When evaluating inclusion/exclusion criteria, a physician investigator discovers a subject meets all inclusion criteria but has one exclusion criterion that appears borderline. What is the appropriate next step?
Answer: Contact the sponsor or medical monitor for clarification before enrolling
Borderline eligibility situations require consultation with the sponsor or medical monitor before enrollment to protect subject safety and protocol integrity.
Which physical examination finding would most likely trigger exclusion from a cardiovascular clinical trial that prohibits QTc interval >450 ms?
Answer: QTc interval of 460 ms on screening ECG
A QTc interval of 460 ms exceeds the protocol threshold of 450 ms and would exclude the subject from a trial with this cardiac safety criterion.