CCDM Statistical Analysis 5

Question 1

Which sensitivity analysis approach tests whether study conclusions hold when missing data are assumed to be Missing Not at Random (MNAR)?

Accepted Answer

Pattern mixture models or tipping point analysis

Answer

Pattern mixture models and tipping point analyses explore how conclusions change under MNAR assumptions to assess robustness of primary results.

Question 2

What is the purpose of a Q-Q (quantile-quantile) plot in clinical data analysis?

Accepted Answer

To assess whether a dataset follows a specified theoretical distribution such as normal

Answer

A Q-Q plot compares the quantiles of observed data against those of a theoretical distribution; points falling on a straight line indicate a good fit.

Question 3

In a two-period, two-sequence crossover trial, which statistical effect must be tested before interpreting treatment differences?

Accepted Answer

Carryover (sequence-by-period interaction) effect

Answer

A significant carryover effect in crossover trials means Period 1 treatment influences Period 2 outcomes, invalidating the within-subject comparison.

Question 4

The intraclass correlation coefficient (ICC) is most commonly used in clinical trials to quantify:

Accepted Answer

The degree of agreement between raters or reliability of repeated measurements

Answer

ICC measures the proportion of total variance attributable to between-subject variability, reflecting rater reliability or measurement consistency.

Question 5

When a clinical trial reports a statistically significant result but a very small effect size, the most appropriate interpretation is:

Accepted Answer

Statistical significance does not guarantee clinical relevance; the effect size must be evaluated

Answer

Large sample sizes can detect trivially small differences as statistically significant; effect size measures (e.g., Cohen's d, odds ratio) contextualize clinical importance.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Statistical Analysis 5