Data and Safety Monitoring (DSM) Guidelines
The National Institutes of Health (NIH) Policy requires each Institute and Center (IC) to have a monitoring system in place for appropriate oversight and monitoring of all NIH-supported or conducted research to ensure the safety of research participants, the appropriate and ethical conduct of the study; the reliability, validity and integrity of the data; and the availability of data and dissemination of research results in a timely manner. To this end, the NIAMS has developed guidelines for Data and Safety Monitoring (DSM) for the conduct of NIAMS-funded clinical research to fulfill its mandate to ensure a monitoring system is in place as required by this Policy.
The NIAMS DSM guidelines include detailed information about the data and safety oversight process, requirements for a Data and Safety Monitoring Plan (DSMP), and the different types of DSM bodies the NIAMS may consider for oversight of clinical studies. The DSM body may comprise of a committee, also known as a Data and Safety Monitoring Board (DSMB), or single or dual Safety Officer(s) (SOs). Large observational studies may require oversight by an Observational Study Monitoring Board (OSMB). DSM oversight by a DSMB, OSMB, or SO(s) could be either NIAMS-appointed or Principal Investigator (PI)-appointed, referred to as internally-appointed monitoring. Review the full DSM Guidelines for more information.
Guidelines for Internal Safety Monitoring
The NIAMS guidelines for internally-appointed monitoring describes data and safety monitoring oversight by a DSMB/OSMB or SO(s), who are appointed, assembled, and managed by the PI and/or Institution. The guidelines detail the roles and responsibilities of the PI and the internally-appointed monitoring body for the oversight of NIAMS-funded clinical research.
How to Write a Data and Safety Monitoring Plan
The Data and Safety Monitoring Plan (DSMP) template serves as a guide to ensure the PI has given consideration to the various aspects of the study which can impact data and safety of participants. It has been developed by the NIAMS to assist the PI with the writing of a DSMP and details the elements to be included such as Study Overview, Participant Safety, Reportable Events, Interim Analysis and Stopping Rules, Data and Safety Monitoring, and Data Management, Quality Control and Quality Assurance. The DSMP is required for all clinical trials. The NIAMS also requires a DSMP for clinical research studies that are monitored by a DSM body and will discuss with the PI which elements of the DSMP are appropriate to include in their plan. More information about the requirement for a DSMP are found in the NIAMS DSM Guidelines.
Reportable Events Requirements and Guidelines for Investigators Conducting NIAMS-funded Clinical Research Studies
The NIAMS Reportable Events Requirements and Guideline is a document that details the safety reporting process that investigators are required to follow when conducting NIAMS-funded clinical research studies. The goal of these guidelines is to outline the NIAMS requirements for reportable events such as adverse events, serious adverse events, unanticipated problems, protocol deviations, serious or continuing noncompliance and suspension or termination of IRB approval, and to ensure that the proper reporting procedures are followed by study personnel to monitor the safety of research participants.
Data and Safety Monitoring (DSM) Charters
The DSM charter document outlines the NIAMS charge to the DSM body (e.g., DSMB or SO(s)) regarding its responsibilities, composition, and processes for oversight of NIAMS-funded clinical research. A custom charter is created by the NIAMS for each study that requires a NIAMS-appointed DSM body. The charter is intended to be a living document that may be modified at any time.