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Regulatory Knowledge and Support

The Regulatory Knowledge and Support (RKS) Program aims to improve informed consent forms and process using the Novel Executive Summary and Appendix Template (NEAT) form approach; improve the post-approval monitoring of human research studies by providing enhanced quality assurance services, regulatory assistance, and education; facilitate Investigational New Drug or Device Exemption (IND/IDE) applications by offering in-depth and advisory consultations to assist investigators’ ability to meet FDA requirements; extend these resources to our community partners and integrated clinical and CTSA networks.

Leadership

Paula Means, MPA, Program Leader

Contact Information

Joseph Andrews: jandrews@wakehealth.edu | 336-716-7658