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
Setting studies up for success
I can’t say enough about how amazing the service from CTSI has been, and how kind the people have been. They take things that are a mystery to me, and make them very understandable. I would give them five stars every time.
Since I started at the University of Minnesota in 2023, my team has used CRSC services for every project we’ve developed. The CRSC has made the transition from my prior institution much smoother and has really come through when projects faced tight timelines.
Associated fees and funding for services
- Investigator-initiated studies: Studies new to our regulatory specialist team are charged a modest monthly fee.
- Business and industry studies: Start-up and monthly fees.
Office hours
Contact us to coordinate access to office hours:
- CTSI Regulatory Specialists: Available Monday - Friday 8am-3pm
Contact
[email protected]
612-625-4000