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Regulatory support

  • Investigator-initiated clinical trials represent a small but extremely important portion of medical research. In the process of translating basic science discoveries to novel therapies, new drugs or devices may be developed and tested. Bearing this in mind, the John Nasseff Neuroscience Institute Research Department offers a service to assist Allina Health researchers with regulatory obligations that we hope would result in additional clinical research that might not have been pursued due to perceived regulatory hurdles.

    The specific services offered are:

    • Regulatory consultation and planning assistance
    • IRB regulatory support
    • Informed Consent preparation assistance
    • Protocol preparation assistance
    • Case Report Forms (CRF) preparation assistance
    • ClinicalTrials.gov submission and support
    • Regulatory guidance, updates, and education services
    • Assistance determining the need for an FDA-approved IND application
    • Regulatory assistance regarding FDA, NIH, HHS, IBC and other federal and state agencies

    Please contact NeuroscienceResearch@allina.com with specific questions regarding regulatory support for research projects.