Past Education Sessions 2021

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Kaitlin Morrison, PhD takes you through all of the major responsibilities of holding an Investigational New Drug (IND) application. She takes you through errors made in the past, so you can make sure that you don’t make them on your study.

Presenter

J. Kaitlin Morrison, PhD – Director of UNC Lineberger Sponsored Clinical Research

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In this interactive session, well-being scholar/practitioner Dr. Suzie Carmack will facilitate a knowledge sharing session on realistic work/life well-being solutions — with a particular focus on sharing the science of compassion and the the quadratic model of well-being (Eisel, 2020).

Presenter

Suzanne Carmack, PhD, MFA, MEd, ERYT, NBC-HWC – Assistant Professor, Department of Global and Community Health Senior Scholar, Center for the Advancement of Well-Being

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A framework for understanding how inequality affects individual outcomes based on people’s tendency to judge their own needs in comparison to others. 

• Learn how economic inequality shapes human decision making, attitudes, and behavior

Presenter

Keith Payne, PhD – Professor of Psychology and Neuroscience

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Provides an overview of approaches, resources, and projects conducted at the UNC Kidney Center to educate and involve stakeholders throughout research processes.

• Outline patient-centered approaches to conducting research
• Describe methods for meaningful stakeholder engagement throughout all research stages
• Highlight resources developed at the UNC Kidney Center

Presenter

Adeline Dorough, MPH — UNC Kidney Center

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• Introduction to the new WCG IRB Connexus
• Highlighting what’s new
• System walkthrough
• New submission workflow
• System transition “need to know” information
• Resources and support

Presenter

Deena Horowitz — Manager, Institutions Partnership at WIRB

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• Provide latest updates and strategies to protect yourself and your communities
• Describe approved, and next stage investigational treatments and trials
• Current and future impact of COVID-19 on the research agenda

Presenter

Myron Cohen, MD – Director, Institute for Global Health and Infectious Diseases

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• Evaluate the challenges that limit learning and process improvement
• Identify how to engage employees in improvement initiatives
• Investigate how to build a learning organization that can innovate continuously

Presenter

Bradley Staats, Associate Dean of MBA Programs

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• Overview/success stories of using myUNCchart for patient recruitment
• review Epic@UNC security and feature updates and enhancements
• overview and use cases for Best Practice Advisories within Epic for research studies

Presenters

Adam Lee, NC TraCS

Stephanie Deen, UNC Health

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• Describe appropriate monitoring of research
• Differentiate between a monitoring plan (DSMP) and a monitoring board (DSMB)
• Identify what to include in a monitoring plan
• Identify roles and responsibilities of a DSMB
• Understand how to complete the monitoring section of the UNC IRB application

Presenter

Marie Rape, RN, BSN

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Presenters from the Investigational Drug Services (IDS) Pharmacy discuss their new billing models.

• Explain details of IDS billing model
• Define terms used in IDS billing model
• Respond to questions from research community regarding IDS billing

Presenters

Andrew Thorne, PharmD, MS, System Clinical Manager, IDS Pharmacy

Justin Davis, Reimbursement Analyst
IDS Pharmacy

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Presenters from the UNC Office of Human Research Ethics help attendees better understand the relationship between assays and investigational devices.

• Understand the different stages of assay development and apply the applicable regulatory framework, specifically investigational devices regulations
• Accurately complete the IRBIS application, Assay tables, and consent forms to facilitate IRB review processes
• Evaluate when a modification occurs how this will impact the regulatory framework and IRB requirements

Presenters

Cassie Myers, CIP, Director, UNC OHRE

Mike Matamoros, MS, CIP, IRB Quality Improvement/Assurance Manager, UNC OHRE