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Data & Safety Monitoring

Data and Safety Monitoring

We provide support and education to help investigators improve the quality of their research and ensure compliance with federal, state, and institutional regulations.

How We Help

We offer data and safety monitoring of clinical trials to:

  • Ensure continuing participant safety
  • Evaluate the continued validity and scientific merit of the trial
  • Assure protocol compliance and data accuracy
  • Evaluate individual and cumulative participant data in order to make recommendations to the sponsor/PI whether to continue, modify, or terminate the trial
Services

Services

The ITHS Data and Safety Monitoring Program offers the following services related to study start-up:

  • Data Safety Monitoring Plan (DSMP) review and/or development
  • Data Monitoring Committee (DMC) charter development
  • DMC member or Independent Medical Monitor recruitment, onboarding, and training
  • Data reporting tables development
  • Serious Adverse Event (SAE) reporting set-up and forms development

The Data and Safety Monitoring Program also offers the following services:

  • DMC meeting scheduling
  • Receipt and dissemination of data reports to DMC members
  • Facilitating DMC meetings
  • DMC minutes preparation, review, finalization
  • DMC review letter preparation and dissemination
  • SAE receipt, review, and acknowledgement
  • Independent Medical Monitor report receipt, review, and acknowledgement

Contact Us / Ask the Research Navigator

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Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.