Good Clinical Practice (GCP) Practice Exam

Why is it important for an investigator to be independent in a trial?

1. To maintain objectivity and reduce bias

2. To increase funding opportunities

3. To oversee multiple trials simultaneously

4. To conduct marketing of the investigational product

The correct answer is: To maintain objectivity and reduce bias

Independence for an investigator in a clinical trial is crucial because it helps maintain objectivity and significantly reduces the risk of bias. When investigators are independent, they are better able to evaluate data and results without being influenced by external factors such as financial interests, personal relationships, or conflicts of interest. This objectivity is essential for ensuring the integrity of the trial's outcomes and for making sound ethical decisions throughout the study. Maintaining independence means that the investigator can report findings truthfully and accurately, contributing to the overall trustworthiness of the data that will be submitted for regulatory review and to the scientific community. An independent investigator can also uphold the rights and safety of the trial participants without outside influences that might compromise those priorities. The other choices, while possibly relevant in different contexts, do not directly address the core reason for the importance of independence. Funding opportunities might be influenced by an investigator’s independence, but it is not a primary goal of the trial itself. Overseeing multiple trials simultaneously can be challenging and may dilute focus and resources, which could affect the quality of each trial. Conducting marketing for the investigational product runs counter to the objective nature of clinical trials, as it could lead to significant conflicts of interest and ethical dilemmas. These factors highlight why