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UW Health SMPH
American Family Children's Hospital
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Services

The Office of Translational Research Services (OTRS) provides administrative support and guidance for the following aspects of the Translational Research Process to UWCCC members at no cost.

 

Research Property Protection/Agreements

OTRS provides administrative guidance for:

  • Material Transfer Agreements
  • Confidential Disclosure Agreements
  • Intellectual Property Agreements
  • Invention Disclosure Reports
  • Interactions with WARF and Graduate School / Office of Industrial Partnerships

      Learn more about Protection/Agreements

 

Investigational New Drug (IND) Applications

OTRS assists with regulatory services for new IND applications and management of existing INDs:  

  • IND consultation and guidance
  • Support for initial IND submission
  • Serve as primary contact for FDA
  • Support and management for annual report submissions
  • Coordinate FDA conference calls and Type C meetings
  • New IND applications assistance
    (Investigator should have Pre-IND work and protocol development completed)
    • Review the IND application with the Investigator and determine if all components are ready
    • Help facilitate collaborations and connections for completing Pre-IND work as needed
    • Assist in the completion of IND application form
    • Package the IND application for FDA submission

  • Existing IND assistance
    • Submit protocol changes
    • Assist with preparation and submission of the annual report
    • Update the name of the IND holder when needed
    • Submit other necessary documents

      Learn more about Pre-Investigational New Drug (IND) Development

 

Finding / Connecting with Research Resources

OTRS assists with finding research resources needed to complete preclinical testing toward IND submission such as:

  • UWCCC Research Services
  • Other UW Resources
  • National support centers
  • Industry collaborators 

      Learn more about Research Connections

 

Translational Research Grant/Resource Support
OTRS assists in applications for grant funding/resource support for translational research including: 

  • NIH Resource Programs: PREVENT, BrlDGs and NExT
    OTRS develops and oversees a coordinated and managed approach for the submission of PREVENT, BrIDGS and NExT applications including:
    • Giving deadline reminders
    • Providing updates on PREVENT and BrIDGs current foci
    • Facilitating communication with the PREVENT, BrIDGs and NExT programs
    • Assisting administratively with application processes

       Learn more about Grant / Resource Support Mechanisms

 

Regulatory Processes

OTRS in collaboration with the Clinical Research Coordinating Office (CRCO) provides administrative guidance for:

  • Compliance
  • Human Subjects Protection
  • Good Clinical Practice
  • Interactions with FDA, NIH, NCI, DOD, etc.