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Data and Safety Monitoring Plans and FDA Audits

To request any of the templates below, please submit a DDRS service request.

Guidance Documents

  1. Guidance for Data and Safety Monitoring Plans
  2. FDA Audit Preparation Resource and Checklist
Letters of Support
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  • Johns Hopkins Institute for Clinical & Translational Research
    750 E. Pratt Street, 16th Floor
    Baltimore, MD 21202
  • 410.361.7880
  • [email protected]
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Funded by the National Center for Advancing Translational Sciences through the Clinical & Translational Science Awards Program, grant number 1UM1TR004926-01.