Data and Safety Monitoring Plans (DSMP) are meant to assure
that each clinical investigation has a system for appropriate
oversight and monitoring of the conduct of the clinical
investigation. This oversight ensures the safety of the
participants and the validity and integrity of the data.
A DSMP is commensurate with the risks involved with the
investigation. The DSMP can be as simple as the investigator
annually submitting his/her safety and AE information to
the IRB or as complex as having a Data and Safety Monitoring
Board.
NIH now requires a
Data Safety and Monitoring
Plan (DSMP) be submitted
with all proposals using
human subjects. Funding
is being held for investigators
who have not submitted
a DSMP. In most cases,
a proposal submitted
without a DSMP will
not even be considered.
A copy of the DSMP must
also be submitted to
the UW Human Subjects
Office. Contact the
Office of Sponsored
Programs (osp@u.washington.edu)
for more details.
