Data Safety Monitoring for Research
Information on formal ongoing monitoring of data to ensure that research subjects will be protected.
The investigator is responsible for determining if a study needs formal ongoing monitoring of data to ensure that research subjects will be protected. The IRB is responsible for review and evaluation of the plan to ensure the adequacy of the Data Safety Monitoring Plan in relationship to the size, complexity, and level of risk of the proposed research. These responsibilities stem from DHHS and FDA regulations stating a criterion for study approval be that "when appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects 45 CFR 46.111[a][6]:"
Data Safety Monitoring Committee or Boards (DSMC/B)
A DSM Committee or Board is an independent, impartial group set up specifically to monitor a clinical trial (or other study) throughout its duration to determine where continuation of the study is appropriate scientifically and ethically.
Factors that Suggest a Data Safety Monitoring Board is Needed
Data Safety Monitoring Requirements
Data Safety Monitoring Composition and Coordination of Functions with the IRB
Resources for Data Safety Monitoring