Regulatory Assistance

The Clinical Trials Office provides central regulatory support for University researchers through its various resources:

  • The IND/IDE Assistance Program for University Faculty members who hold an Investigational New Drug (IND) or Investigational Device Exemption (IDE)
  • Clinical Research Coordinator (CRC) Training Program for clinical research staff
  • Clinical Trials Monitoring Assistance Program (CTMAP) for University Faculty members who serve as Sponsor-Investigators (S-Is) holding an IND or IDE
  • ClinicalTrials.gov assistance for researchers throughout the Columbia University community

For guidance on remote monitoring, please follow this link.

Services

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CRC Training Program
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ClinicalTrials.gov Registration
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IND/IDE Assistance Program (IAP)
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Brown Bag Sessions and Newsletters
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Consultation Services
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Regulatory Binder