The goal of the Regulatory Knowledge and Support (RKS) Program is to facilitate the safe, efficient and ethical conduct of clinical and translational research across SCTR. Our primary objective is to provide focused support for regulatory compliance and management through service and education. Our efforts also intend to provide support navigating the regulatory enviornment, alleviate the bureaucratic barriers, streamline workflows and accelerate the learning curve while continuing to uphold the highest standards in the protection of human subjects. Specific aims include:
1. Providing access to Regulatory services.
2. Engaging stakeholders, including current and potential research subjects and health professionals.
3. Continue the SCTR-catalyzed efforts to streamline regulatory review and approval.
4. Expand the Research Subject Advocacy (RSA) Core to assist in providing optimal human subject protection.
5. Provide regulatory training curriculum to promote Good Clinical Practice (GCP), medical ethics, and knowledge of federal and state regulations.