CCA CATO Associate Patient Recruitment & Retention 2 — Questions and Answers
Question 1: Why is subject retention important in longitudinal clinical trials?
- It reduces the cost of IP supply
- It prevents missing data, maintains statistical power, and reduces bias that could affect trial validity (Correct answer)
- It eliminates the need for screen failure documentation
- It allows the study to close earlier
Correct answer: It prevents missing data, maintains statistical power, and reduces bias that could affect trial validity
High subject retention is critical to maintaining statistical power, minimizing missing data, and preventing attrition bias that could invalidate trial results.
Question 2: What is an 'early termination visit' (ETV) in the context of subject retention?
- An unscheduled visit triggered by an SAE
- A protocol-specified visit conducted when a subject withdraws from the study before completing all scheduled visits (Correct answer)
- The final scheduled visit for all subjects
- An interim analysis visit
Correct answer: A protocol-specified visit conducted when a subject withdraws from the study before completing all scheduled visits
An early termination visit is conducted when a subject withdraws early, capturing remaining safety and efficacy data per the protocol.
Question 3: A subject expresses a desire to withdraw from the clinical trial. What must the investigator do?
- Try to persuade the subject to continue by explaining the benefits
- Respect the subject's right to withdraw without penalty, ensure safety follow-up as required, and document the withdrawal (Correct answer)
- Require the subject to provide a written reason before processing the withdrawal
- Notify the IRB before allowing the subject to withdraw
Correct answer: Respect the subject's right to withdraw without penalty, ensure safety follow-up as required, and document the withdrawal
Subjects have the right to withdraw at any time without penalty; the investigator must respect this, ensure safety follow-up, and document the reason if provided.
Question 4: What strategy is commonly used to improve subject retention in long-term clinical trials?
- Reducing the frequency of required visits regardless of protocol
- Regular check-in calls, visit reminders, simplified visit scheduling, and reimbursing travel costs (Correct answer)
- Increasing financial incentives mid-trial without IRB approval
- Allowing proxy consent for adults who miss visits
Correct answer: Regular check-in calls, visit reminders, simplified visit scheduling, and reimbursing travel costs
Proactive contact, reminder systems, flexible scheduling, and reimbursing inconvenience costs are evidence-based strategies for improving retention.
Question 5: When a subject misses a scheduled study visit, what should the site staff do first?
- Remove the subject from the trial immediately
- Attempt to contact the subject to reschedule, document the missed visit, and assess any safety concerns (Correct answer)
- Notify the IRB of non-compliance
- Unblind the subject to determine if continued participation is needed
Correct answer: Attempt to contact the subject to reschedule, document the missed visit, and assess any safety concerns
When a visit is missed, staff should promptly attempt contact to reschedule, document the missed visit per protocol, and assess subject safety.
Question 6: What is the term for a subject who cannot be located for follow-up visits or safety assessments?
- Protocol violator
- Lost to follow-up (LTFU) (Correct answer)
- Screen failure
- Non-compliant subject
Correct answer: Lost to follow-up (LTFU)
A subject who cannot be contacted or located for required follow-up is classified as 'lost to follow-up' (LTFU), which must be documented and reported.
CCA CATO Associate Patient Recruitment & Retention 2
Why is subject retention important in longitudinal clinical trials?