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

In the context of a CSR, what does p-value signify?

1. The estimated cost of the trial

2. The strength of the evidence against the null hypothesis

3. The number of subjects enrolled in the trial

4. The duration of the study

The correct answer is: The strength of the evidence against the null hypothesis

In the context of a Clinical Study Report (CSR), the p-value specifically signifies the strength of the evidence against the null hypothesis. This value is derived from statistical tests that help researchers determine whether the observed results of a trial are statistically significant or could have occurred by random chance alone. A low p-value (typically less than 0.05) indicates strong evidence against the null hypothesis, suggesting that the treatment or intervention being studied has a meaningful effect. Conversely, a high p-value indicates weak evidence against the null hypothesis, implying that the results may not be significant and could potentially be due to chance. This concept is foundational in hypothesis testing within clinical research, where researchers aim to ascertain whether their findings can be generalized beyond the sample studied, thus contributing to the body of evidence in medical science. The focus on the p-value is essential for understanding the statistical validity of the conclusions drawn from a clinical trial.