Regulatory Start-up Support Services

The CCTS Regulatory Knowledge and Support core can help investigators navigate the study start-up process by providing the following services:

  • 2 hour complimentary consultation

  • Assistance with IRB and/or FDA submissions

  • Assistance with protocol development

  • Creation of a regulatory binder

  • Assistance with regulatory documents (i.e. 1572, financial disclosure, site signature, delegation log, CV, medical license, laboratory certification, etc.)

  • Serve as a liaison with study sponsor



Learn more about the Regulatory Knowledge and Support Core. »

Regulatory Start-Up Team
Our Team: Front, L to R: Ellen Hartman, Terri Spear, Marietta Barton-Baxter, Laura Ashe Back, L to R: William Stoops, Reva Bruns, Ada Sue Selwitz