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 CRF data compliance

First day of the 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