Certified Clinical Research Coordinator (CCRC) Practice Exam

In a double-blind study, who remains unaware of the treatment assignments?

1. Only the subjects

2. The subjects, investigator, monitor, and sometimes analyst

3. Only the investigators and monitors

4. All involved parties including sponsors

The correct answer is: The subjects, investigator, monitor, and sometimes analyst

In a double-blind study, the primary purpose is to eliminate bias in the treatment effects assessed by keeping both the subjects and the investigators unaware of which participants are receiving the treatment and which are receiving a placebo or an alternative treatment. This is crucial for maintaining the integrity of the study and the validity of the results. The correct answer encompasses not just the subjects and the investigators, but also the monitors and potentially the analysts, meaning that a broader array of individuals involved in the study are kept in the dark regarding treatment assignments. This level of blinding helps to minimize any potential biases from both the participants and the researchers, as neither will have preconceived notions about the outcomes based on their knowledge of treatment assignment. Involving monitors in this blinding process ensures that they can objectively assess data and ensure compliance without any biases stemming from knowledge of who is receiving which treatment. Furthermore, while not always common, sometimes analysts are also kept blinded, especially when analyzing data to prevent bias in interpretation. This comprehensive approach to blinding is essential for deriving reliable and unbiased conclusions from the research, making option B the most accurate choice.