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Forms and Guidance

Forms

  • Forms and Guidance
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Initial Application Forms

  • Protocol application form – non-exempt, 01.02.2025
  • Protocol application form – exempt, 01.02.2025
  • Data and Specimen Analysis Form, 10.27.2023
  • Research Registry or Repository form, 12.2.2024
  • PI assurance form, 01.16.2025
  • Research team form, 08.03.2023
  • Human subjects research determination form, 6.13.2024
  • 118 Determination Letter or “Just-in-Time” request form, 07.19.2023
  • International research form 07.15.2024
  • Certificate of translation form 07.19.2023
  • Investigational Device Checklist 5.15.2024
  • Post-approval Forms

  • Modification form, 07.19.2023
  • Protocol closure form, 03.22.2024
  • Renewal form, 07.19.2023
  • Incident, Adverse Event, or Reportable New Information form 03.25.2024
  • Multi-site Research and Reliance Forms

    • Reliance Plan or Multi-site Review Plan – 10.25.2023
    • NU IRB of Record – Relying Site Intake Form – 10.25.2023
    • NU Relying – Reliance Intake Form – 10.25.2023
    • NU Relying – Research Team Form – 10.25.2023

Please note: Please complete the forms using Word. The IRB uses Track Changes to provide comments and feedback on submissions. We advise against the use of cloud-based tools (such as Google docs) to complete the protocol form. We have noted some formatting incompatibilities that may make it difficult to review the protocol.

 

See Getting Started for guidance on how to submit an initial study