What we do
The ICTS Regulatory Core helps investigators navigate the regulatory requirements process by collaborating with researchers to work directly with the IRB and other regulatory agencies.
The ICTS Regulatory Core provides training, services, education, and other resources to anybody at the University of Iowa that is doing research.
Services
The ICTS Regulatory Core can support researchers in the following areas:
Early Regulatory Development
Interaction to develop regulatory plan. This can include sIRB assistance prior to grant submission, FDA IND/IDE consultation or submission, feasibility visits with sponsors, assistance with protocol and Data Safety Monitoring Board creation, and clinicaltrials.gov consultation or submission.
Education and Training
We can provide individual or group regulatory education and training to researchers and study staff or study groups.
Regulatory Submissions and Maintenance
We can prepare, submit, and maintain HawkIRB, commercial IRB, and sIRB submissions. We can also assist investigators, coordinators, and study staff in their submissions.
FDA Inspections
The ICTS Regulatory Core can be a resource to researches and study staff when preparing for an FDA inspection or preparing and implementing responses to the FDA inspection.
Walk-in Hours
Virtual walk-in hour support
Wednesday 1:30 pm-2:30 pm CST
Join us here via zoom
Contact Information
Debra O'Connell Moore, MBA
- Email: debra-oconnell-moore@uiowa.edu
- Phone: 319-356-1693