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 Policies and Operations
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: COM-OP-5: DSMC Procedures, Review and Data Compliance
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
First week of the preceding month
Due date for DSMC Monitoring Form
2-3 weeks prior to meeting date
Fourth Tuesday of each month
The DSMC requires the following information for review:
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: COM-OP-6: DSMB Procedures and Review