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

All trial phases assess safety. Is this statement true or false?

1. True

2. False

3. Only in Phase I

4. Only in Phase II and III

The correct answer is: True

The statement that all trial phases assess safety is true. In clinical research, safety monitoring is an essential component throughout all phases of a clinical trial, not limited to any specific phase. In Phase I trials, the primary focus is to assess the safety and tolerability of a new treatment, often involving a small group of healthy volunteers. This phase helps identify any potential side effects and determines how the drug is processed in the body. In Phase II trials, researchers continue to assess safety while also evaluating the effectiveness of the treatment in a larger group of participants who have the condition the treatment is intended to address. Here, safety data collected can lead to critical insights about the drug’s benefit-risk profile. Phase III trials expand on this further, involving even larger populations to provide more comprehensive data regarding both the safety and efficacy of the treatment before it can be considered for approval by regulatory authorities. These trials aim to confirm the findings from earlier phases and gather more information on the treatment’s safety in a real-world setting. Thus, all phases of clinical trials actively monitor and assess safety, making the original statement accurate.