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 are for studies with finalized protocols.

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

Associated fees and funding for services

  • Investigator-initiated studies: Beginning July 1, 2024, any study new to our regulatory specialist team will be charged a modest monthly fee.
  • Business and industry studies: Start-up and monthly fees.

View rates

Office hours

Contact us to coordinate access to office hours:

  • CTSI Regulatory Specialists: Available Monday - Friday 8am-3pm

Contact

[email protected]
612-625-4000