Regulatory Knowledge and Support Program (RKS)
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PROGRAM DESCRIPTION
Ensuring that the more than 1,000 clinical research studies that open annually across our hub are compliant, efficient and safe, requires comprehensive regulatory tools and consultative services. The Regulatory Knowledge and Support Program (RKS) provides investigators with expert regulatory guidance and advice to facilitate clinical and translational research in conformance with Institutional Review Board (IRB) policies, state laws and federal regulations.
PROGRAM AIM
Provide tools and support to facilitate compliant clinical and translational research.
- Provide tools and support to facilitate creation of high-quality protocols.
- Implement and optimize regulatory workflows with the use of electronic regulatory binders and DocuSign integration.
- Develop an FDA IND/IDE knowledge hub, pre-IND regulatory support services, and support for FDA issues regarding mHealth and emergent digital health technologies.
- Adapt regulatory and ethics training and consults for community-based research.
