Sponsor-Investigator (GCP) CITI Training FAQs

1. Who must complete Sponsor-Investigator (GCP) training on CITI?

  • IRB policy requires mandatory training for investigators who are also serving as sponsors, (e.g., holding an Investigational New Drug (IND), Investigational Device Exemption (IDE), or abbreviated IDE), for an FDA-regulated clinical investigation. A Sponsor-Investigator must complete the applicable drug or device Good Clinical Practice training on CITI before final IRB approval is granted. The ReGARDD Training Modules on IND Sponsor-Investigator Responsibilities [HTML] may be substituted for the CITI GCP course by providing completion documentation to ORI (HSPTrainingSupport@uky.edu).
    • If the Sponsor-Investigator has documentation of completion of equivalent training, email course completion documentation to HSPTrainingSupport@uky.edu.
  • Sponsor-Investigators may also choose to require completion of the training by staff who will be involved in the conduct of the study. This is encouraged for sub-investigators to whom any sponsor responsibilities will be delegated. 

2. How do I complete the CITI training specifically required for Sponsor-Investigators of FDA regulated clinical research?

  • You may enroll initially from the Courses page after logging in to your account. Scroll to the bottom of your Courses page then click "Add a Course" under Learner Tools for University of Kentucky.
  • Add a course
  • Select Human Subject Protection (HSP), then click Next.
    Choose Human Subject Protection
  • Select Good Clinical Practice (GCP) training, then click Next.
  • Choose GCP training
  • Select Initial or Refresher, then click Next.
  • Choose Initial or Refresher
  • Select applicable course, then click Next.
  • Initial training:
  • Choose GCP course
  • Or Refresher training:
    CITI GCP Refresher courses
  • You are directed back to your Courses page where it states you are now enrolled. 
  • Scroll down to "Courses Ready to Begin" and click Start Now to complete the Initial HSP training.
  • GCP Course ready to begin