ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Data and Safety Monitoring Plan (DSMP)

A DSMP is a defined plan with individuals identified for monitoring research on an individual protocol. A DSMP can establish review under: a Principal Investigator; an independent individual/safety officer; a designated medical monitor; an internal committee or board with explicit guidelines; a Data and Safety Monitoring Board; or the IRB itself. The Data and Safety Monitoring Plan details the criteria for unexpected adverse event (AE) and serious adverse event (SAE) monitoring, and data and safety reviews throughout the expected timeframe of the protocol. The Committee approves DSMPs during the original protocol submission.

Publication Source: Committees on Human Research

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