Data and Safety Monitoring

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

DSMC Monitoring Form DSMB Monitoring Form Contact Us

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HCC Policies and Operations

HCC DSMC

The 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	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:

The PI and study team must prepare an updated DSMC Monitoring Form prior to each DSMC review. Completed forms should be sent to ODQDataSafety@dfci.harvard.edu prior to the due date listed on the DSMC memo. Please remember to include any attachments, as indicated on the form.
The DSMC monitors data submission compliance in accordance with COM-OP-5: DSMC Procedures, Review, and Data Compliance. For trials where data is captured in HCC InForm EDC, the lead study team provides the DSMC with a recent Missing Forms Report (MFR) as part of the DSMC Monitoring Form submission.
The report must be dated within 2 weeks prior to the DSMC monitoring form submission deadline. For studies where the MFR is available in the Reports section of InForm, the full DSMC report (including the summary of toxicities) must be provided in PDF format. Otherwise, for studies where the MFR is available through OnCore only, the MFR Summary Detail report in OnCore must be provided in PDF format.
For more information on MFRs, including instructions, please see ODQ's Data Management page.
ODQ provides the DSMC with a detailed protocol report from the OnCore CTMS system prior to each review. This report includes, but is not limited to, the following information:
- Basic trial information (e.g., sponsor, sites, accrual goal)
- Current accrual numbers – total and by site
- Breakdown of subject status (registration, treatment start/end, off study)
The PI and study team should check that registration and subject status information in OnCore is up to date to ensure the DSMC has accurate information for review.
ODQ provides the DSMC with an OHRS protocol report from the OnCore CTMS system prior to each review. This report includes, but is not limited to, the following information:
- Summary of all SRC and IRB reviews (e.g., amendments, continuing reviews)
- List of Adverse Event Reports reviewed by the IRB
- List of Other Events reviewed by the IRB

HCC DSMB

The 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 HCC PI is the Study Chair AND there is no established DSMB

For more information: COM-OP-6: DSMB Procedures and Review