Data Safety and Monitoring

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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.

Determine if a study needs a Data and Safety Monitoring Board

As per NIH guidelines, Data and Safety Monitoring Board (DSMB) is required for all Phase III clinical investigations (or any multi-site clinical trial) involving interventions that entail potential risk to participants. For phase I and II trials, a DSMB may be appropriate if the studies have multiple sites, are blinded, or employ particularly high-risk interventions or vulnerable populations.

The DSMB will act as an independent advisory group to the Sponsor. The DSMB is responsible for safeguarding the interests of study participants, assessing the safety and efficacy of study procedures, and for monitoring the overall conduct of the sponsored studies. Information on DSMB can be found in the protocol and may be required for completing the eIRB application and the consent form.

eIRB is mandatory for all IRB submissions.