Regulatory Knowledge and Support

Core Description

The Research Support Center supports the TRI Regulatory component services for each step of a protocol by insuring research subject safety and compliance with local, state and federal regulations.

The RSC comprises a diverse team of experienced professionals who provide essential support to the UAMS research community, enabling the development of well-designed, ethical research studies while balancing regulation and innovation in a continuously changing environment. The Research Support Center of UAMS provides support for the planning, conduct, and monitoring of human and animal research studies. The RSC provides the following services: Research Subject Advocacy; Protocol Writing; Budget Development; Medicare Coverage Assessment;Medicare Coverage Assessment;FDA Regulatory Support (INDs/IDEs);Clinical Trials Registry; Quality Assurance (GMP/GTP/GLP Product Processing and Control; and Study Monitoring.

The Committee for Clinical Research (CCR) oversees the development of the Research Support Center (RSC). The CCR is charged with directing the redesign of institutional review and approval pathways consistent with current federal and state laws and regulations.

Links to Regulatory Resources

Clinical Trials Registry http://www.uams.edu/rsc/Units/ClinicalTrials.asp

Federal Regulations http://www.uams.edu/rsc/Federal regulations.htms

Quality Assurance (GMP/GTP/GLP) http://www.uams.edu/rsc/Units/QualityAssuranceUnit.asp

Regulatory Affairs Unit http://www.uams.edu/rsc/Units/RegulatoryAffairsUnit.asp

Study Monitoring http://www.uams.edu/rsc/Units/MonitoringUnit.asp

Core Director

Tom Wells, MD, MBA

Core Research Director

Lawrence Cornett, PhD

Associate Dean for Translational Research

Aubrey Hough, MD

UAMS Translational Research Institute
4301 W. Markham #Slot 577, Little Rock, AR 72205, 501-614-2287


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