Skip to main content

Data and Safety Monitoring Committee

The University of North Carolina Lineberger Comprehensive Cancer Center (UNC Lineberger) is committed to the safety of subjects participating in clinical trials. The UNC Lineberger Data and Safety Monitoring Committee (DSMC) provides ongoing safety monitoring for all cancer center investigator-initiated oncology clinical trials. This includes therapeutic, as well as interventional basic science, diagnostic, prevention, screening, and supportive care studies. The DSMC is one of the committees responsible for oversight of data and safety monitoring on UNC Lineberger investigator-initiated trials (IITs).

The DSMC meets the 4th Monday of every month except for a combined November/December meeting which meets the 2nd Monday of December.

The DSMC reviews regular reports from the trial PI, as well as reports of Serious Adverse Events (SAEs) and Adverse Events (AEs). Based on these reviews and other information, the DSMC may request additional data pertaining to subject safety, satisfactory data management, quality and analysis, recruitment, and protocol adherence and may reserve the option, at any point in the trial, to obtain an independent audit of a sample of primary subject records for comparison with the trial’s regular audit reports. Auditors so engaged will report directly to the DSMC Chair.

Submission information and requirements

The DSMC reviews oncology studies from UNC Lineberger IITs. The DSMC reviews any IIT that is cancer focused and/or involves cancer patients. Some of these studies will involve the use of the Clinical Trials Office (CTO), while some trials will use other resources.

Please contact the DSM Coordinator at denise_schwandt@med.unc.edu with questions about the review process.

Information for DSMC Review

The DSMC uses the Risk/Complexity score to help determine the frequency of reviews; however, frequency of reviews is based on individual studies and the final vote of the committee.

Risk or Complexity Assignment Frequency of Reporting Guidelines
Minimal Risk Annually based on IRB anniversary date; DSMC may opt to exempt from review
Moderate Risk Bi-annually for trials with a complexity rating of > 2; or DSMC may opt for annual review
Phase I, Phase I/II, and Dose Escalation Trials (any phase) Monthly review of AEs and SAEs; full DSMC review every three months
High Risk Phase II Bi-annually based on the IRB anniversary date
High Risk Phase III High-risk Phase III trials require an independent data and safety monitoring board (study DSMB).  At the direction of the DSMB chair, an alternative mechanism may be established to fulfill this function.
Complexity Rating ≥4 Quarterly review
Studies with Institutional Conflict of Interest Requiring External Reviewers Monthly review of AEs and SAEs; full review every three months conducted and presented to the DSMC by external reviewers

 

Required Documents for DSMC Review

For each DMSC review, summary information regarding toxicity and accrual patterns, including information from all multicenter sites participating in the trial, is required, along with supporting documentation.

  1. DSMC Study Report Forms
  1. Required Supporting Documentation
  • Stopping rules (extracted language from the protocol)
  • OnCore generated toxicity (AE) reports
    • Data Operations provides toxicity reports for all CTO treatment trials
    • Non-CTO study teams must provide their own toxicity logs
  • SAE reports
    • Data Operations provides toxicity reports for all CTO treatment trials
    • Non-CTO study teams must provide their own toxicity logs
  • Deviations, violations, PRIs, and UPs
  • Eligibility and treatment exceptions
  • Monitor reports
  • Audit reports
  • Significant literature reporting any developments that may affect subject safety or trial ethics
  • Team meeting minutes for the review period
  • Interim analysis results
  • Protocol – most recent version