Data and Safety Monitoring

The Office of Data Quality (ODQ) provides administrative support to the DF/HCC Data and Safety Monitoring Committee (DSMC) and DF/HCC Data and Safety Monitoring Board (DSMB). Please contact us at ODQDataSafety@dfci.harvard.edu with any questions.

DF/HCC DSMC

The DF/HCC DSMC reviews high-risk pilot, Phase I and Phase II protocols , including:

  • PI-Initiated Pilot, Phase I, I/II and II (non-randomized) protocols
  • First in human and/or children protocols
  • Gene transfer protocols
  • Vaccine trials using live or attenuated viruses

For more information: DSMC Charter 

DSMC Review Process and Timeline

The DSMC meets monthly to review toxicity, data submission compliance and accrual. 

Protocols are reviewed every 3, 6 or 9 months based on the protocol status, accrual rate, and review of ongoing safety indicators. ODQ notifies the PI and lead study team of the next upcoming DSMC review for a given protocol.
 

Key Deadlines and Dates

Typical Schedule

Notifications sent

First week of the preceding month

Due date for DSMC Monitoring Form

2-3 weeks prior to meeting date

DSMC Meeting

Fourth Tuesday of each month

 
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The DSMC requires the following information for review:

DF/HCC DSMB

The DF/HCC DSMB reviews large, randomized protocols that otherwise do not have an independent DSMB assigned. These trials include:

  • PI-Initiated Phase III protocols
  • PI-Initiated randomized Phase II protocols with comparative endpoints
  • Externally sponsored Phase III or randomized Phase II protocols with comparative endpoints where the DFHCC  PI is the Study Chair AND there is no established DSMB

For more information: DSMB Charter