CPI Patient Assessment & Evaluation 2 — Questions and Answers
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:
- 0
- 1
- 2 (Correct answer)
- 3
Correct 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.
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?
- Enroll the subject immediately since 6 weeks exceeds the washout period (Correct answer)
- Exclude the subject because washout periods are approximate and need a safety margin
- Consult the sponsor before enrolling since 6 weeks is close to the required interval
- Delay enrollment by an additional 4 weeks to ensure full washout
Correct 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.
Question 3: Which element of a patient's medical history is MOST critical to document during clinical trial screening to assess eligibility?
- Social and family history only
- All prior and concomitant medications, diagnoses, procedures, and allergies (Correct answer)
- Chief complaint and reason for visit
- Insurance and billing information
Correct 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.
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?
- Only at the next scheduled visit
- Only if the subject reports side effects
- At the earliest opportunity, such as a phone call or unscheduled visit (Correct answer)
- At study completion during the end-of-study assessment
Correct 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.
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?
- A negative urine pregnancy test performed any time in the prior month
- A negative serum or urine pregnancy test within the timeframe specified in the protocol (Correct answer)
- A verbal confirmation from the subject that she is not pregnant
- A negative test result on file from her primary care physician
Correct 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.
Question 6: 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?
- Enroll the subject and document the deviation
- Contact the sponsor or medical monitor for clarification before enrolling (Correct answer)
- Exclude the subject without further inquiry
- Have the subject sign the consent form and decide eligibility after enrollment
Correct 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.
Question 7: Which physical examination finding would most likely trigger exclusion from a cardiovascular clinical trial that prohibits QTc interval >450 ms?
- Heart rate of 72 bpm
- Blood pressure of 128/82 mmHg
- QTc interval of 460 ms on screening ECG (Correct answer)
- Mild aortic stenosis murmur
Correct 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.
CPI Patient Assessment & Evaluation 2
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: