University of Vermont

University of Vermont Clinical Research Center

Data Safety Monitoring Plan

Data Safety Monitoring Plan (DSMP)

In May of 2001 the National Advisory Research Resources Council adopted the “Recommendation to GCRC’s for Patient Safety in Clinical Research” This document outlined the requirement that each protocol submitted to the GCRC have a data safety monitoring plan (DSMP) in place. Four elements of a DSMP are required:

  1. Adverse events must be graded for severity
  2. A plan for reporting adverse events must be in place
  3. A plan for annual reporting of adverse events must be in place, and
  4. A plan for safety review(by whom and at what frequency must be established).

Under some circumstances a data safety monitoring board (DSMB) may be required. This might include, but not be limited to:

  • Phase III randomized controlled trials,

  • Trials within which blinding to medication administration is present, or

  • Protocols perceived as having particularly high risk to human subjects.

It will be the GCRC Scientific Advisory Committee that will determine the need for safety evaluations beyond the need for a data safety and monitoring plan.

To assist investigators in meeting this requirement the Research Subject Advocacy office has created draft language that may be used by investigators to describe the operation of a data safety monitoring plan that meets current requirements. Investigators should feel free to include this draft language in their protocols if it meets any additional requirements unique to the study. The principal investigator is free to create an alternate DSMP as long as it includes the required 4 elements noted above. As a reminder, all of the reporting processes included in this description (UVM/FAHC CHRMS Adverse Event. and the Safety Alert for Events (SAFE) reporting systems are already in place and apply to ongoing research even if the protocol has not specifically stated a DSMP.

DSMP draft language

Last modified September 12 2008 11:46 AM

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