A study protocol must contain which of the following elements?

A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.

GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.

"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results."

Objectives:

Maintain transparency in data analysis.

Ensure scientific rigor in evaluating study outcomes.