Data Safety and Monitoring

The monitoring of a clinical trial is an essential element of study processes designed to ensure the protection of the subject's rights, the safety of subjects enrolled in the trial, and the integrity and quality of the resulting data. This Data Safety Monitoring Plan (DSMP) describes the specifications for monitoring as required for the project.

The DSMP will be reviewed and approved by the Regulatory Sponsor prior to study activation. This information is required to estimate the intensity and frequency of monitoring for initial budget build.