IRB submission preparation

CTSI's Regulatory Specialists support and guide investigators through the IRB submission process by completing submission processes for new and ongoing studies and providing guidance for best practice regulatory documentation. Services for studies with finalized protocols include:
 

Consultations

  • On regulatory and IRB submission process-related questions
     

Start-up support

  • Submit for Ancillary Reviews
  • Complete ETHOS submissions
  • Draft consent, assent, HIPAA, and Local Addendum documents
  • Draft response to stipulations for PI review
     

Ongoing support

  • Draft IRB Continuing reviews
  • Draft Modification submissions and update consents as needed
  • Draft and submit report forms to IRB
  • Consult with study team regarding general regulatory binder maintenance
  • Advise study team on regulatory issues
     

Rates
 

Contact
612-625-4000
[email protected]
Experts who support
Regulatory Specialists