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.
All investigation requires monitoring.
The monitoring plan should be commensurate with the risks.
Monitoring should be commensurate with the size and complexity of the investigation.
It is not necessary that the DSMP cover all possible aspects of each guideline down to the last detail. Rather, the plan should describe processes for dealing with these elements such that a reasonable reviewer would conclude that the institution or investigator has a serious, robust process in place for assuring the safety of research participants and the oversight of data integrity.
Minimum Required DSMP Content
The minimum required DSMP content includes the following.
Assessment of level of risk of the investigation
The entity that will be responsible for monitoring
Adverse event (AE) grading and attribution scale
Plan for unanticipated AE reporting
Plan for annual reporting of AEs
Plan for safety review – by whom and at what frequency
Plan for monitoring of data quality and accuracy
The assessment of the level of risk of the investigation is an important component of the DSMP, as it determines the intensity and structure of the subsequent monitoring procedures. The NIH requires a DMC for Phase III clinical investigations (or any multi-site clinical trial) involving interventions that entail potential risk to participants. In general this would apply to all risk-level IV studies, and may include some risk-level III studies. These requirements apply to all investigations regardless of source of funding, (NIH, industry, local, etc.). The ultimate decision regarding the level of risk of the investigation, and thus the monitoring requirements, will be made by the IRB, and, for ITHS Clinical Resource supported projects, the Research Subject Advocate. For more information, view NIH guidance on when DMCs are needed.
Tool for Developing a DSMP
The ITHS member institutions have developed a tool, the ITHS Partner Institutions Joint Tool for Data and Safety Monitoring Plans (DSMP), to describe the current institutional thinking regarding the creation of an appropriate DSMP for clinical research trials involving human subjects. Contributions were made by compliance experts, IRB chairpersons, IRB administration and other professionals in clinical research. We highly recommend that you review this tool prior to creating your study-specific DSMP.