• What is the Data & Safety Monitoring Committee

• Why investigators should use the Data & Safety monitoring Committee

• The process for employing the Data & Safety Monitoring Committee

What is the Data & Safety Monitoring Committee

As of October 2000, the NIH is requiring a data & safety monitoring plan for all Phase I and Phase II clinical trials ( link to NIH regulation ).  As part of a data & safety monitoring plan, a data & safety monitoring board can be assembled to convened to provide oversight of the clinical trial. 

The Center for Gene Therapy provides a Data & Safety Monitoring Committee (DSMC) to assist researchers in maintaining the safety of their clinical trials.  The DSMC will work in conjunction with GCRC and the IRB to ensure the researchers stay in compliance.

The DSMC has three standing members and can draw in ad hoc members as the projects demand.  The standing members are:

• Richard H. Simon, M.D.
  Dr. Simon is a professor of Internal Medicine with a research focus on cystic fibrosis and inflammatory lung injury.
  Biographical information
   

• Morton B. Brown, Ph. D.
  Dr. Brown is a professor of Biostatistics with a research focus on both methodological and applied biostatics. 
  Biographical Information
   

• Faye S. Silverstein, M.D.
  Dr. Silverstein is a professor of Neurology and Pediatrics with a research focus on cellular and molecular mechanisms that contribute to perinatal brain injury.
  Biographical Information