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