Data and Safety Monitoring Plan

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NIH: For each NIH-supported clinical trial, NIH requires a data and safety monitoring plan that will provide oversight and monitoring to ensure the safety of participants and the validity and integrity of the data. The level of monitoring should be commensurate with the risks and the size and complexity of the clinical trial. A detailed data and safety monitoring plan must be submitted to the applicant's IRB and subsequently to the awarding IC for approval prior to the accrual of human subjects.

NHLBI: designed by the investigator and approved by Program Staff to ensure safety of human subjects and integrity of data.

PVAMU: A plan to oversee the implementation of a study protocol for subjects’ safety and compliance monitoring.