What is data safety monitoring plan

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What is a data safety monitoring plan (DSMP)? A DSMP is a plan written by the researcher that ensures the safety of research participants and protects study data integrity. A DSMP is a document that lists all the technologies in the study and describes how safe they are. A DSMP is a report submitted to the IRB when a breach of confidentiality occurs. A DSMP is a living document that changes based on serious adverse events reported to the sponsor.

Reference no: EM133871730

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