Designing a data and safety monitoring plan.
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.
Research Subject Advocacy Program, General Clinical Research Center, University of Illinois Medical Center at Chicago, USA.
Lynda
L
Slimmer
Burton
B
Andersen
D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics / Q000458:organization & administration*; D003625:Data Collection / Q000941:ethics / Q000379:methods / Q000592:standards; D019317:Evidence-Based Medicine / Q000941:ethics / Q000592:standards; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000941:ethics / Q000592:standards*; D006801:Humans; D009316:National Institutes of Health (U.S.); D015399:Nursing Research / Q000941:ethics / Q000592:standards*; D010934:Planning Techniques; D012107:Research Design / Q000592:standards*; D012109:Research Support as Topic / Q000941:ethics / Q000458:organization & administration; D018570:Risk Assessment / Q000941:ethics / Q000458:organization & administration; D017751:Safety Management / Q000941:ethics / Q000458:organization & administration*; D014481:United States