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Data and 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.

Services

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

How researchers use this resource or service

How researchers use this resource or service

Although we can assist you at any point during your study, the best time to obtain a consultation for data and safety monitoring services is prior to submitting your study’s grant proposal. We can review your data and safety monitoring plan, make recommendations, and draft a cost estimate based on your study’s anticipated needs.

Start-up Services

Start-up Services

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

  • 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

Additional Services

Additional Services

Whether your study requires an Independent Medical Monitor or a full Data Monitoring Committee, our skilled ITHS Data and Safety Monitoring Program staff can also manage these additional services for you:

  • 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

Fees

Fees

For more information or to request a price quote, please contact us by using the form below.

Contact Us

Contact Us

Request Services

Request Services

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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.