regulatory binders

Regulatory specialist rate changes: FY25

More and more University of Minnesota researchers are turning to CTSI’s regulatory specialists for regulatory support for their clinical trials. We now support nearly 500 active studies and continue to grow. 

To accommodate this burgeoning demand and better meet the needs of the researchers we serve, we will be implementing a modest monthly fee. This will allow us to expand our team of regulatory specialists. 

Investigator-initiated studies

Beginning July 1, 2024, any investigator-initiated study new to our regulatory specialist team will be charged a flat monthly fee as follows:

  • Local IRB review: $50/month
  • External IRB review: $75/month

Investigator-initiated studies supported prior to this date will not be subject to this new fee.

Business and industry studies

Also beginning July 1, 2024, industry-sponsored study rates are increasing for the first time since 2020. The new rates are as follows:

  • One-time start-up fee: $3,000 (previously $2,850)
  • Maintenance fee: $200/month (previously $190)

This updated pricing will apply to all industry-sponsored studies, including those that our regulatory specialist team currently supports. 

These rates can be found on our Regulatory Specialists webpage. PIs that currently use the service were notified in May.

Please note these rate changes only affect the support provided by our regulatory specialists, which are listed on that same webpage. It does not affect other types of regulatory support that CTSI provides, such as for clinical trial monitoring, ClinicalTrials.gov, FDA submissions, or Florence eBinders.

For questions, contact Sydney Viel, MPH, CPH, CTSI’s Regulatory Affairs Program Manager at [email protected]