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  • 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

Industry Initiated Clinical Research

What

The Green Line outlines the processes specific to Industry Initiated Clinical Research that are:

  • Designed, written and initiated by a For-Profit Entity
  • Contracted to ISMMS to conduct
  • The IND/IDE holder (if applicable) is the For-Profit sponsor
  • The for-profit entity is the sponsor and funding source for the study

How

Use the “Stops” on the Green Line to navigate ISMMS research processes and procedures throughout the research project life cycle.

Research 411 Portal

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Navigate 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
    • 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
  • 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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