Research Ethics/Regulatory Knowledge and Support (RE/RKS) Component
The RE/RKS component facilitates the conduct of clinical and translational research from the regulatory perspective, improving compliance and efficiency. RE/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 RE/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.
- 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
HIPAA FAQs 2015 (pdf)