Past Education Sessions 2019

Click the year to view slides and recordings of past NRP education sessions. (NOTE: Recordings are hosted on various platforms depending on how each session was recorded.)

Research in Epic Updates

Dec 12, 2019

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Ed Finerty and Stephanie Deen

Protecting Research Data

Oct 17, 2019

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  • Define Sensitive Information
  • Appropriate data collection, use, sharing and storage methods in research
  • HIPAA and NC ID Theft Protection Act
  • Purchasing process

Micki Jernigan, Chief Privacy Officer, ITS
Larry Fritsche, Senior Security Operations Manager, ITS
Brian Penders, Chief Information Security Officer, School of Medicine

Clinical Research Symposium: Laying the Foundation for Clinical Research Excellence

May 17, 2019

view slides: GCP Update | Laying the Foundation for Clinical Research Excellence | Managing Study Compliance | FDA-Regulated Devices and Determinations

The 2019 Symposium brings together content area experts in the field of Clinical Research. This knowledge-based symposium features a mix of didactic lectures and panel discussions aimed at improving the implementation of research principles.

Keynote address: Dr. Quincy Byrdsong, Director for Research Administration — WellStar Research Institute

Target Audience: Principal Investigators, Clinical Research Coordinators, Research Nurses, Regulatory Associates, Data Managers, Program Managers, Research Administrators, and Research Assistants of all experience levels.

Why the Clinical Trial Agreement Matters

Apr 18, 2019

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  • Important budget and payment terms (payment timelines, BCA, required start-up fees, F&A Rate)
  • Regulatory concerns
  • Liability (subject injury, indemnification, use of hospital facilities)

Liz Thornberry Moore, JD
Christine Nelson, RN, BSN, MBA, CCRC

Preparing for April 6 Epic Upgrade: Tools for Research Coordinators

Mar 21, 2019

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Describe new tools for study management such as IRB date tracking, Task Lists, Amendment Tracking and

  • Describe how Adverse Event tracking will function in Epic 2018
  • Explain how changes in the Epic Research record such as IRB approval and expiration dates, IDE listing and study tasks will make it easier to keep up with studies
  • Recognize how Contraindicated Medications will be handled in Epic 2018
  • Recognize best practices for visit linking and billing

Ed Finerty and Stephanie Deen

Common Rule Update

Feb 21, 2019

  • Review the major changes of the revised Common Rule
  • Summarize how UNC has operationalized the revised Common Rule and any JIT updates
  • Review new guidance available to the research community
  • Summarize the future updates to IRBIS

Mike Matamoros, John Thomas Roberts, Cassandra J Myers

Sponsor-Investigator Responsibilities

Jan 17, 2019

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  • Identify sponsor-investigator responsibilities related to clinical research regulations
  • Summarize common problems found during FDA inspections
  • Apply methods to ensure compliance with regulations and guidelines for sponsor-investigators

Jamie Kauwell, MHA, CCRC, CHRC
Marisa Corbett, BA, CCRC

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