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

What approach should be taken to ensure the integrity of bias avoidance in a randomized trial?

1. Maintain participant confidentiality

2. Ensure proper documentation and treatment allocation

3. Limit participant information dissemination

4. Skip statistical analysis

The correct answer is: Ensure proper documentation and treatment allocation

Ensuring proper documentation and treatment allocation is crucial in a randomized trial for maintaining the integrity of bias avoidance. Accurate documentation helps in tracking the recruitment process, understanding the randomization procedure, and verifying that participants are assigned to treatment groups appropriately. By doing so, it minimizes the risk of selection bias, as it guarantees that every participant has an equal chance of being placed in any treatment or control group. Proper treatment allocation is also essential for blinding, which further reduces performance and detection bias. Researchers and participants should be unaware of group assignments when possible, which helps prevent conscious or unconscious influences that could skew the results of the trial. Thus, meticulous attention to documentation and allocation procedures directly supports the reliability and validity of the trial outcomes. In contrast, maintaining participant confidentiality, limiting information dissemination, and skipping statistical analysis do not address the core issues related to bias in treatment allocation and monitoring, making them less relevant to the integrity of the randomized trial.