Regulatory Affairs Certification (RAC) Practice Exam

Which stage of clinical trials does NOT require inclusion in the clinical trial registry?

1. A Phase I studies

2. B Phase II studies

3. C Phase III studies

4. D None of the above

The correct answer is: A Phase I studies

The correct answer indicates that Phase I studies do not require inclusion in the clinical trial registry. This is primarily due to the nature of Phase I trials, which are typically focused on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug in a small group of healthy volunteers or patients. The intention behind the requirement for registration is to promote transparency and accountability in clinical research, particularly for studies that are larger and likely to have more significant implications for patient safety and treatment efficacy. As clinical trials progress into Phase II and Phase III, the need for registration becomes increasingly important, as these phases involve larger populations and are designed to gather more comprehensive data on the efficacy and safety of the intervention. While Phase I studies are important, they generally do not have the same level of scrutiny and public interest as later phase studies, which is why their registration is not mandated. This distinction highlights the evolving nature of clinical research and the regulatory requirements associated with different phases.