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
When assessing an elderly subject (age 78) for clinical trial enrollment, which factor is MOST important to evaluate beyond standard eligibility criteria?
Answer: Functional status, comorbidities, polypharmacy, and cognitive capacity to provide informed consent
Geriatric assessment in clinical trials requires evaluation of functional status, comorbidities, polypharmacy risks, and cognitive capacity to ensure safe participation and valid consent.
A subject with a documented history of bipolar disorder is being screened for a non-psychiatric clinical trial. What is the investigator's primary responsibility regarding mental health assessment?
Answer: Assess current psychiatric stability, medication compliance, and whether the disorder affects consent capacity
The investigator must assess current psychiatric stability and consent capacity; a history of bipolar disorder does not automatically disqualify a subject if they are currently stable and can provide informed consent.
The Karnofsky Performance Status scale scores subjects from 0 to 100. A subject who requires occasional assistance but can care for most personal needs has a Karnofsky score of approximately:
Answer: 70
A Karnofsky score of 70 describes a subject who cares for themselves but is unable to carry on normal activity or active work, requiring occasional assistance.
A validated pain assessment tool widely used in clinical trials for adult subjects who can self-report is the:
Answer: Numeric Rating Scale (NRS) 0-10
The Numeric Rating Scale (NRS) 0-10 is a validated, widely used self-report pain measure for adults in clinical research, where 0=no pain and 10=worst imaginable pain.
A subject reports a history of chronic kidney disease (CKD) Stage 3b. Which renal function test should the investigator prioritize to assess current eligibility against a protocol threshold?
Answer: Serum creatinine to calculate eGFR using CKD-EPI or Cockcroft-Gault
Serum creatinine-based eGFR calculation (CKD-EPI or Cockcroft-Gault) provides the quantitative renal function measure most protocols use to define eligibility thresholds.
Which tool is commonly used to screen for cognitive impairment and assess consent capacity in elderly clinical trial subjects?
Answer: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA)
The MMSE and MoCA are validated cognitive screening tools used to identify cognitive impairment that may affect a subject's capacity to understand and consent to clinical trial participation.
A protocol excludes subjects with 'active autoimmune disease requiring systemic treatment within the past 2 years.' A subject has a history of rheumatoid arthritis currently controlled with topical treatment only, last systemic treatment 3 years ago. What is the eligibility determination?
Answer: Eligible because systemic treatment ended more than 2 years ago
The exclusion criterion specifies 'systemic treatment within the past 2 years'; this subject's last systemic treatment was 3 years ago, so they meet this criterion for eligibility.