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Industry Initiated Clinical Research
  • Industry Initiated Clinical Research
  • Confidential Disclosure Agreement (CDA)
  • Feasibility
  • Preparation for Submission
    • Training
    • Recruitment and Retention
    • Medicare Coverage Analysis (MCA)
    • 21 CFR Part 11 Compliance
    • Conducting a Device Study
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    • Budget Development and Negotiation
    • CRO Account Information Forms
  • Study Submission Workflow
    • Annual Report of Outside Relationships (eDMS Disclosure Profile)
    • Triggering Event (TE)
    • FCOIR – Research Trigger Form (project-specific form)
    • Start GCO Application
    • IRB Submission
    • Contracts & Budget Submission
    • GCO Submission
    • Local MAC Approval for Device Trials
    • OnCore CTMS (Clinical Trials Management System)
  • Site Initiation Visit (SIV)
  • Epic Registration of Clinical Trials
  • Translation and Interpretation Services for Research
  • Study Management
  • Financial Management
  • Monitoring and Audits
  • Study Closeout or Termination
  • Document Retention and Disposal

  • Industry Initiated Clinical Research
  • Confidential Disclosure Agreement (CDA)
  • Feasibility
  • Preparation for Submission
    • Training
    • Recruitment and Retention
    • Medicare Coverage Analysis (MCA)
    • 21 CFR Part 11 Compliance
    • Conducting a Device Study
    • Approvals Needed for Research
    • Budget Development and Negotiation
    • CRO Account Information Forms
  • Study Submission Workflow
    • Annual Report of Outside Relationships (eDMS Disclosure Profile)
    • Triggering Event (TE)
    • FCOIR – Research Trigger Form (project-specific form)
    • Start GCO Application
    • IRB Submission
    • Contracts & Budget Submission
    • GCO Submission
    • Local MAC Approval for Device Trials
    • OnCore CTMS (Clinical Trials Management System)
  • Site Initiation Visit (SIV)
  • Epic Registration of Clinical Trials
  • Translation and Interpretation Services for Research
  • Study Management
  • Financial Management
  • Monitoring and Audits
  • Study Closeout or Termination
  • Document Retention and Disposal

Approvals Needed for Research

Z

Human Subject – Institutional Review Board – Ancillary Office Reviews

Depending on the nature of your research, the following institutional approvals may be required.

  • BioMe® Biobank Steering Committee
  • COVID-19 Protocol Review Committee
  • Cancer Related Research - Protocol Review and Monitoring Committee (PRMC)
  • Clinical Research Unit (CRU) 
  • Cybersecurity Risk Assessment
  • Data Use Committee
  • Embryonic Stem Cell Research Oversight Committee (ESCRO)
  • Financial Administration of Clinical Trials Services (FACTS)
  • In-Patient Nursing Resources
  • Institutional Biosafety Committee (IBC)
  • Institutional Review Board (IRB)
  • Investigational Drug Services (IDS)
  • Laser Safety Committee
  • Radiation Safety Committee
  • Transfusion Medicine and Cellular Therapy
  • Department or Institute Specific
    • BioMedical Engineering and Imaging Institute (BMEII)
    • Department of Anesthesiology, Perioperative and Pain Medicine
    • Department of Genetics and Genomic Sciences
    • Department of Medicine - Protocol Review Committee (PRC)
    • Department of Neurosurgery - Neurosurgery Clinical Research Feasibility Committee

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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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