Where are analysis sets defined in a protocol?

Where are analysis sets defined in a protocol?

• A. Case report form
• B. Data monitoring committee charter
• C. Monitoring plan
• D. Statistical section of the protocol

Answer: (D)

The analysis sets are defined in the statistical section of the protocol. This section specifies which participants are included in each analysis population (for example, an intention-to-treat population, a per-protocol population, and a safety population) and under what conditions they are included. Defining these sets upfront in the protocol ensures that the planned analyses are transparent and prespecified, which helps prevent bias. While a separate statistical analysis plan may provide more detailed methods, the protocol itself establishes the core definitions of the analysis populations. Other items like the case report form, the data monitoring committee charter, or the monitoring plan serve different purposes and do not define analysis sets.

The analysis sets are defined in the statistical section of the protocol. This section specifies which participants are included in each analysis population (for example, an intention-to-treat population, a per-protocol population, and a safety population) and under what conditions they are included. Defining these sets upfront in the protocol ensures that the planned analyses are transparent and prespecified, which helps prevent bias. While a separate statistical analysis plan may provide more detailed methods, the protocol itself establishes the core definitions of the analysis populations. Other items like the case report form, the data monitoring committee charter, or the monitoring plan serve different purposes and do not define analysis sets.