CATO Associate Patient Recruitment & Retention Flashcards
6 cards from real CCA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CATO Associate Patient Recruitment & Retention flashcards as text
Why is subject retention important in longitudinal clinical trials?
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.
What is an 'early termination visit' (ETV) in the context of subject retention?
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.
A subject expresses a desire to withdraw from the clinical trial. What must the investigator do?
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.
What strategy is commonly used to improve subject retention in long-term clinical trials?
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.
When a subject misses a scheduled study visit, what should the site staff do first?
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.
What is the term for a subject who cannot be located for follow-up visits or safety assessments?
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.