The National Institutes of Health (NIH) advocates making available to the public the results and accomplishments of the activities that it funds. Guideline for Budgeting for Data and Safety Monitoring Activities (MS Word, 25K) aids investigators in budgeting for an independent DSMB or a Safety Officer when preparing the budget section of a grant application.Investigators submitting grant applications for clinical trials are required to include a general description of the DSMP as part of the research grant application. The DSMP outlines procedures that investigators and study staff will follow when implementing a clinical trial. All clinical trials require study-specific monitoring procedures to ensure participant safety and data integrity. Data and Safety Monitoring Plan (DSMP) Template and Guidelines (MS Word, 37K) and DSMP Checklist (MS Word, 43K) were developed to assist investigators in preparation of a sound data and safety monitoring plan.For example, for a single-site, low risk study, the PI may propose a local safety monitor, while a multi-site, higher risk study might propose a Data and Safety Monitoring Board (DSMB). Data and safety monitoring of a clinical trial is commensurate with the risks posed to the study participants and with the size and complexity of the study.Īpplicants requesting support for any intervention study must complete "PHS Human Subjects and Clinical Trials Information" form of the SF424 (R&R), describe a data and safety monitoring plan (DSMP), which discusses the need for an independent data and safety monitoring body or justifies why such a body is not needed to monitor the study and proposes an alternative safety monitoring mechanism. The Toolbox contains templates, sample forms, guidelines, regulations and informational materials to assist investigators in the development and conduct of high quality clinical research studies.Īs depicted in the NIA Guidance on Clinical Trials, NIA is responsible for overseeing the data and safety monitoring of the clinical research it supports. The purpose of the NIA Clinical Research Toolbox is to provide a Web-based informational repository for investigators and staff involved in clinical research.
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