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

Which variable in a clinical study is primarily considered when determining the sample size?

1. Secondary variable

2. Primary variable

3. Control variable

4. Outcome variable

The correct answer is: Primary variable

In a clinical study, the sample size is primarily determined by the primary variable, which is the main focus of the research. The primary variable is the specific outcome or effect that the study aims to measure and analyze, such as the effectiveness of a treatment or the incidence of a condition. This variable directly influences the study's design and the statistical power required to detect a significant effect if one exists. When calculating sample size, researchers consider the expected effect size related to the primary variable, the level of significance they wish to achieve, and the power of the study. These factors ensure that the sample size is sufficient to provide reliable and valid results regarding the primary variable. Other variables, such as secondary, control, or outcome variables, do play roles in the overall study design and can influence analyses but do not primarily dictate the sample size calculation. The primary variable is the cornerstone of this calculation, as it directly relates to the research question and the hypothesis being tested.