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Regulatory Knowledge & Support

The Regulatory Knowledge and Support (RKS) Module facilitates the conduct of clinical and translational research from the regulatory perspective, improving compliance and efficiency. RKS provides regulatory support to CTSI-CN investigators, spanning the regulatory process involved in the pre-study stage, active-study stage, and post-study stage. The RKS team has extensive regulatory experience, including FDA submissions, preparation of IRB applications, maintenance of approvals, adverse event reporting, protocol amendments and required annual renewals.

Resources include:

  • Sponsor and FDA required regulatory submissions
  • Preparation of IRB applications, using the IRBear system
  • Participant Advocacy program
  • Consultation for regulatory issues
  • Human Subject Protection training

To request support, click here.

Resource Documents:
HIPAA FAQs 2015 (pdf)