Why should the Data Manager review the study protocol?

The Data Manager should review the study protocol primarily to understand the primary and secondary endpoints of the research. These endpoints are crucial as they define the main outcomes the study aims to measure and inform the overall goals of the trial. A comprehensive understanding of these endpoints ensures that the Data Manager can accurately collect, manage, and analyze data relevant to the objectives of the study.

Understanding the endpoints also enables the Data Manager to implement appropriate data management practices, ensuring that the data collected aligns with the study's objectives. This understanding is vital for maintaining the integrity and scientific validity of the study's data.

While compliance with FDA regulations, assessing financial conflicts of interest, and preparing regulatory filings are important tasks, they are not the primary reasons for a Data Manager to review the protocol. These activities are typically overseen by other roles within the research team or may require additional documentation beyond the study protocol itself. Therefore, the focus on the primary and secondary endpoints underscores the specific responsibilities of the Data Manager in supporting the research process effectively.