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Clinical Research Support Office

Devices and Clinical Research: A Refresher on Billing and Regulatory Requirements

Apr 2, 2026, 12:00 – 1:00 PM

Session Description: -An overview of FDA and CMS regulatory framework for investigational devices, including key distinctions among device types -Coverage analysis considerations -Regulatory requirements, with particular emphasis on Investigational Device Exemptions (IDEs) for Categories A and B

Mara Leach

Mara Leach
Clinical Trials Coverage Analyst, Senior

Email: mle271@uky.edu

Emilee Shape

Emilee Shape
Clinical Trial Compliance Administrator

Email: Emilee.Shape@uky.edu

Clinical Research Support Office Annual Update

Feb 5, 2026, 12:00 – 1:00 PM

FY25 CRSO Clinical Research Update including staff, project, and metrics updates as well as a live demo of our recently implemented Advarra eReg electronic regulatory binder system. Presented by:Jessica Heskel, MBACRSO Executive Director Bibi Broome, MACRSO Research Systems Educator

CRSO’s Open Office Hours

Jun 26, 2026, 10:00 – 11:00 AM

Research investigators and staff are encouraged to come to the Clinical Research Support Office's (CRSO) weekly office hours with questions about any of the research technologies that are administered and supported by the CRSO. These include: OnCore CTMS Advarra eSource + EDC Advarra eREG Members of the CRSO’s Research Systems Management and Education (RSME) team will be available to answer questions and provide in-person support.

CRSO’s Open Office Hours

Jun 19, 2026, 10:00 – 11:00 AM

Research investigators and staff are encouraged to come to the Clinical Research Support Office's (CRSO) weekly office hours with questions about any of the research technologies that are administered and supported by the CRSO. These include: OnCore CTMS Advarra eSource + EDC Advarra eREG Members of the CRSO’s Research Systems Management and Education (RSME) team will be available to answer questions and provide in-person support.

CRSO’s Open Office Hours

Jun 12, 2026, 10:00 – 11:00 AM

Research investigators and staff are encouraged to come to the Clinical Research Support Office's (CRSO) weekly office hours with questions about any of the research technologies that are administered and supported by the CRSO. These include: OnCore CTMS Advarra eSource + EDC Advarra eREG Members of the CRSO’s Research Systems Management and Education (RSME) team will be available to answer questions and provide in-person support.

CRSO’s Open Office Hours

May 29, 2026, 10:00 – 11:00 AM

Research investigators and staff are encouraged to come to the Clinical Research Support Office's (CRSO) weekly office hours with questions about any of the research technologies that are administered and supported by the CRSO. These include: OnCore CTMS Advarra eSource + EDC Advarra eREG Members of the CRSO’s Research Systems Management and Education (RSME) team will be available to answer questions and provide in-person support.

CRSO’s Open Office Hours

May 22, 2026, 10:00 – 11:00 AM

Research investigators and staff are encouraged to come to the Clinical Research Support Office's (CRSO) weekly office hours with questions about any of the research technologies that are administered and supported by the CRSO. These include: OnCore CTMS Advarra eSource + EDC Advarra eREG Members of the CRSO’s Research Systems Management and Education (RSME) team will be available to answer questions and provide in-person support.

CRSO’s Open Office Hours

May 15, 2026, 10:00 – 11:00 AM

Research investigators and staff are encouraged to come to the Clinical Research Support Office's (CRSO) weekly office hours with questions about any of the research technologies that are administered and supported by the CRSO. These include: OnCore CTMS Advarra eSource + EDC Advarra eREG Members of the CRSO’s Research Systems Management and Education (RSME) team will be available to answer questions and provide in-person support.

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