What do Data and Safety Monitoring Plans address?

Data and Safety Monitoring Plans (DSMP) are specifically designed to ensure the safety and well-being of participants involved in clinical trials. They provide a structured framework for monitoring the data collected during research to identify any potential risks to participants, ensuring that appropriate measures are in place to address these risks.

A key focus of DSMPs is to evaluate the safety data on an ongoing basis, which is crucial for making timely decisions about the continuation or modification of a study. This oversight is imperative, especially in clinical trials where procedures may carry unforeseen risks as new data emerges. By closely monitoring participant safety, such plans help to uphold ethical standards and protect the integrity of the research process.

The other choices, while relevant to different aspects of clinical research, do not specifically pertain to the fundamental role of data and safety monitoring in protecting participants' well-being and addressing risk.