Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

When considering participation in a study, what should the investigator determine regarding patient eligibility?

1. If the treatment regimen is effective

2. If he/she sees enough patients who would qualify for the study

3. If funding is available for the research

4. If there are enough staff members to assist

The correct answer is: If he/she sees enough patients who would qualify for the study

Determining patient eligibility is a critical aspect of study design and execution. The investigator needs to assess if they see enough patients who qualify for the study to ensure adequate representation and statistical power in the trial. This consideration influences the feasibility of recruiting a sufficient number of participants who meet the specific inclusion and exclusion criteria outlined in the study protocol. Successful recruitment of eligible patients is crucial for the study's goals and outcomes. If an investigator does not have access to enough eligible patients, the research might face delays, limited data, or even failure to reach its objectives. This means that understanding the patient population and how many could potentially meet the eligibility requirements is foundational for the study's success. The other considerations listed, such as treatment effectiveness, funding availability, and staff assistance, are certainly important to the overall management of a study. However, they do not directly pertain to the specific act of determining patient eligibility as the primary focus. In this context, the number of patients that can be recruited is essential to framing and executing the research appropriately.