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  • Investigator Initiated Clinical Research
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Navigate Investigator Initiated Clinical Research
  • Investigator Initiated Clinical Research
  • Getting Started
    • Pre-Protocol Development
    • Technology Commercialization
    • Funding Resources
    • Training
    • ISMMS Approvals Needed for Research
  • Develop Proposal
    • Protocol Development
    • Multi-Site Study Support
    • Grant Proposals and Applications
    • Budget Development
    • Device Studies
  • Submission Process
    • Annual Report of Outside Relationships (eDMS Disclosure Profile)
    • Triggering Event (TE)
    • FCOIR – Research Trigger Form (project-specific form)
    • Suspension and Debarment (S&D) Form
    • Start GCO Application
    • FACTS – For-Profit Clinical Research Agreements
    • GCO & Extramural Submission
  • Regulatory Requirements
    • IRB and IACUC Approvals – When Do You Need to Submit?
    • IRB Submission
    • IACUC Submission
    • FDA
      • Do you Need an IND?
      • Do you Need an IDE?
    • ClinicalTrials.gov Registration and Reporting
  • Award Setup and Management
    • Award Setup
    • Award Management
  • Study Activation and Management
    • Study Activation
    • Study Management
    • Recruitment and Retention
    • Epic Registration of Clinical Trials
    • Translation and Interpretation Services for Research
    • Monitoring and Audits
  • Closeout
    • Award Closeout
    • Study Closeout
  • Publications
  • Data Management
  • What’s New
  • Office of Research Services
  • Research Roadmap
  • The Conduit
  • Help
  • FAQ

Supported by the Clinical and Translational Science Awards (CTSA) grant UL1TR004419 from the National Center for Advancing Translational Sciences, National Institutes of Health

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