To enhance efficiency and rigor, NIH intends to modernize the approach to data and safety monitoring and is committed to engaging the public in development of an updated policy. Since the 1998 NIH Data and Safety Monitoring Policy was published, study designs and monitoring practices have evolved, creating the need for more efficient and flexible practices to monitor data for all clinical research. NIH plans to modernize the Data and Safety Monitoring Policy starting with gathering input from the public, experts in the field, and the research community.
NIH Videocast
Draft Agenda
Meeting Flyer
Public Comments
All types of clinical research studies can – and should – have a plan for monitoring data and safety. These studies include a broad range of clinical research studies, such as observational studies, behavioral and social science research, implementation science, and clinical trials of drugs and devices.
- Data and safety monitoring plans identify the approach and procedures for monitoring the quality and scientific reliability of the data, and the safety of participants.
- Plans include procedures for evaluating and reporting on the data and safety of the study.
- Plans identify the appropriate level of monitoring for the study and describe how that monitoring will be conducted.
- Monitoring can range from the principal investigator only to including an independent monitor(s) or committee, like a Data and Safety Monitoring Board (DSMB).
NIH welcomes any comments on modernizing the Data and Safety Monitoring (DSM) Policy. We accept any comments, but we are specifically interested in hearing individual opinions on the following topics:
- Study characteristics that should be considered when evaluating what an appropriate monitoring approach, plan, or level of monitoring is for the study. For example, this could include the study design, types of outcomes, data privacy and security, US or global regulatory structure, number of sites, and quantity and types of data.
- Key components of an effective data and safety monitoring plan; considering data, safety, scientific integrity, protocol adherence, and study continuation.
- Types of research that should be covered under the modernized DSM policy. Key categories are 1) all clinical research (including clinical trials and non-clinical trials) and 2) all research involving humans, including identifiable private information or specimens (i.e., secondary research involving de-identified private information or biospecimens).
- Guidance, templates, or educational material that would help the research community 1) understand data and safety monitoring principles, 2) develop effective data and safety monitoring approaches and plans, and 3) implement data and safety monitoring rigorously and to the highest ethical standards.
Registration
The webinar is open to the public and there is no cost to attend. Registration is required using the form below.