Designing a Data and Safety Monitoring Plan

Abstract

Evidence-based nursing practice is now the expected standard of care intensifying the need to conduct clinical research studies to investigate the efficacy of nursing interventions. To ensure that the urgency to document such efficacy does not compromise human participant safety, government research funding agencies are advocating special procedures to protect individuals who voluntarily participate in research studies. The National Institutes of Health application for clinical trial funding requires a data and safety monitoring plan (DSMP) to enhance human participant safety and clinical research integrity. This article describes an approach to developing a DSMP that includes a study risk assessment and a monitoring design based on that assessment.

Keywords

human participant safety data and safety monitoring

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