The Data and Safety Monitoring Plan (DSMP) helps ensure the safety of participants, the validity of data, and the appropriate termination of studies for which significant benefits or risks have been uncovered or when it appears that the investigation cannot be concluded successfully.
Clinical Research Center (CRC) requirements for data and safety monitoring are based on overall requirements from NIH and the National Center for Advancing Translational Research (NCATS), which supports the CRC. NIH policy requires that investigators submit a general description of the DSMP for clinical investigations (biomedical and behavioral intervention studies) as part of the research application.
A general description of a monitoring plan establishes the overall framework for the study’s data and safety monitoring. It should describe the entity that will be responsible for monitoring, and how adverse events (AEs) will be reported to the Institutional Review Board (IRB), the CRC, and the appropriate federal agencies (NIH, Office of Biotechnology Activities (OBA) and/or FDA) in accordance with current NIH and/or FDA and local or state regulations.
The detailed DSMP must be reviewed and approved prior to the initiation of the study, as part of the application to use the CRCN. DSMPs may be submitted concurrently to the IRB and to the SRC (as part of the application) for parallel review.
Principles to Consider
When designing an appropriate DSMP the following principles should be considered.