CATO Associate Patient Recruitment & Retention Flashcards
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Which regulatory body must approve advertising materials used for subject recruitment in US-based clinical trials?
Answer: The IRB/IEC prior to use
All recruitment advertising materials must be reviewed and approved by the IRB/IEC before use to ensure they are not coercive and are appropriate for the target population.
What does 'vulnerable population' mean in the context of clinical trial recruitment?
Answer: Individuals whose autonomy may be compromised, such as minors, prisoners, pregnant women, or cognitively impaired persons
Vulnerable populations include individuals whose ability to provide truly voluntary informed consent may be compromised and who therefore require additional ethical protections.
What is a 'run-in period' in the context of clinical trial subject recruitment?
Answer: A pre-randomization phase during which subjects' eligibility, compliance, or baseline characteristics are assessed before full enrollment
A run-in period is a pre-randomization phase used to assess subject eligibility, compliance, washout prior medications, or establish a stable baseline.
What is the 'randomization ratio' in a clinical trial, and why does it matter for recruitment?
Answer: The allocation ratio of subjects to treatment arms (e.g., 2:1 active to placebo), which affects sample size and enrollment planning
The randomization ratio defines how subjects are allocated to treatment arms and directly impacts the sample size needed in each arm to power the trial.
What is 'competitive enrollment' in the context of multi-site clinical trials?
Answer: A model where multiple sites recruit from a shared enrollment pool on a first-to-enroll basis, without pre-assigned quotas per site
Competitive enrollment allows all active sites to enroll from a shared pool until the overall target is met, rather than assigning fixed enrollment caps per site.
Why is it important to document subject recruitment source in the screening log?
Answer: To evaluate which recruitment strategies are most effective and to provide an audit trail for regulatory review
Tracking recruitment source helps sponsors evaluate the effectiveness of different strategies and provides regulatory auditors with a complete picture of how subjects were identified.