Certified Clinical Research Coordinator (CCRC) Practice Exam

Which phase is primarily focused on ensuring participant safety while evaluating dosage?

1. Phase I

2. Phase II

3. Phase III

4. Phase IV

The correct answer is: Phase I

Phase I of clinical trials is primarily focused on ensuring participant safety while evaluating dosage. During this phase, the study is conducted with a small group of healthy volunteers or patients, where the primary objective is to assess the safety of the drug or treatment being tested. Researchers closely monitor participants for any adverse effects and gather data on how the drug is metabolized, particularly focusing on determining the optimal dosage that minimizes risks while providing therapeutic benefits. It is important for this phase to establish a safe dosage range before progressing to later phases of clinical trials, where larger groups of patients are treated and more complex data about effectiveness and side effects are collected. The emphasis on safety and dosage evaluation in Phase I sets the groundwork for subsequent phases, where the focus shifts more towards efficacy and broader population impact.