Month Flat Week Day

Mon. 2 May, 2022

Odum Institute: Integrated Mixed Methods: Bridging Qualitative and Quantitative Methods and Results - Day 1

Mon. 2 May, 2022 10:00 am - 12:30 pm

This three-day (5/2, 5/4, and 5/6) course will be offered via Zoom. Attendance is required as the course will not be recorded.

Course Summary:

Integrated mixed methods are used to answer questions that necessitate more than one method to achieve a holistic understanding. Combining qualitative and quantitative approaches can enhance conversations about theory, practice, and/or policy. This demanding paradigm requires knowledge, skill, and expertise in quantitative and qualitative methods, as well as the art of intentionally integrating the approaches to and findings from each mode of inquiry.

This course focuses on strategies, tips, and best practices to accomplish integration in accessible and effective ways, including:

- Rationales to guide decision-making related to study design and execution
- Conceptual, theoretical, and/or logic models as roadmaps to set the stage for and guide integration
- Analytic strategies that advance frameworks and dynamic processes of connecting, building, merging, embedding, and bridging


Instructor: Alison Hamilton

Alison B. Hamilton, Ph.D., M.P.H., a VA Research Career Scientist and Professor-in-Residence in the UCLA Department of Psychiatry and Biobehavioral Sciences, received her Ph.D. in medical and psychological anthropology from UCLA in 2002, and her M.P.H. in Community Health Sciences from UCLA in 2009. Dr. Hamilton is the Director of the VA-funded EMPOWER (Enhancing Mental and Physical Health of Women through Engagement and Retention) Quality Enhancement Research Initiative (QUERI), focused on improving women Veterans’ health and health care through implementation science. She is the Chief Officer of Implementation & Policy at the VA Health Services Research and Development (HSR&D) Center for the Study of Healthcare Innovation, Implementation and Policy at the VA Greater Los Angeles Healthcare System, specializing in women Veterans’ health, mental health services research, and implementation science.

She is also PI of a large-scale NIH study of enhancing organizational and individual readiness to address cardiovascular risk among individuals living with HIV. She was a fellow in the inaugural cohort of the NIMH/VA Implementation Research Institute and she serves as an Associate Editor for Implementation Science Communications (BMC) and on the editorial boards of Implementation Science (BMC), Women’s Health Issues (Elsevier), and Implementation Research and Practice (Sage).

Dr. Hamilton has been a consultant with ResearchTalk for over 20 years, providing direct support to clients as well as serving as faculty for several of the Qualitative Research Summer Intensives and mentor at ResearchTalk’s Qualitative Methods Camps. At recent Intensives, she has taught courses on qualitative methods in implementation research, rapid qualitative research methods, qualitative grant-writing, qualitative interviewing, integrated mixed methods research, and enhancing the usefulness of qualitative research. Dr. Hamilton is a co-author of Dr. Ray Maietta’s Sort and Sift, Think and Shift (forthcoming, Guilford).

Registration Fees
- UNC-CH Students: $0, with a $35 deposit to hold your spot (deposit is refundable upon your attendance for at least 66% of the course)
- UNC-CH Faculty/Staff/Postdoc: $95
- Non UNC-CH: $145

Additional Course Registration
- Registration will close at 12:01 am on 4/29/2022. Once registration closes, no late registrations will be accepted, no exceptions.
- Cancellation/ Refund Policy: A full refund will be given to those who cancel their registration no later than 10 days prior to the course. If you cancel within 10 days prior to the class, no refund will be given. Please allow 30 days to receive your refund.
- Zoom link for this course will be sent prior to the course. Registration must be made at least 3 days prior to the course date to receive the Zoom link.
- For questions regarding the status of this class, please contact Jill Stevens at This email address is being protected from spambots. You need JavaScript enabled to view it..

Register

Tue. 3 May, 2022

Orientation for New Clinical Research Personnel: Spring 2022 - Day 1

Tue. 3 May, 2022 1:00 pm - 3:30 pm

Orientation for New Clinical Research Personnel is returning for Spring 2022! The curriculum is designed to be a true orientation for new research personnel (either new to UNC or new to research altogether), but anyone is welcome to attend. The orientation will be held via Zoom on May 3 and 4, from 1-3:30 p.m. Topics covered in the orientation will include:


- The Research Landscape at UNC Chapel Hill
- The Research Study Life Cycle and Different Types of Research Studies
- Good Clinical Practice
- Overview of Research Regulations and Research Processes
- Overview of Research Roles and Responsibilities
- Informed Consent

Register


Please contact Catherine Barnes at This email address is being protected from spambots. You need JavaScript enabled to view it. if you have questions regarding this training. 

Wed. 4 May, 2022

Odum Institute: Integrated Mixed Methods: Bridging Qualitative and Quantitative Methods and Results - Day 2

Wed. 4 May, 2022 10:00 am - 12:30 pm

This three-day (5/2, 5/4, and 5/6) course will be offered via Zoom. Attendance is required as the course will not be recorded.

Course Summary:

Integrated mixed methods are used to answer questions that necessitate more than one method to achieve a holistic understanding. Combining qualitative and quantitative approaches can enhance conversations about theory, practice, and/or policy. This demanding paradigm requires knowledge, skill, and expertise in quantitative and qualitative methods, as well as the art of intentionally integrating the approaches to and findings from each mode of inquiry.

This course focuses on strategies, tips, and best practices to accomplish integration in accessible and effective ways, including:

- Rationales to guide decision-making related to study design and execution
- Conceptual, theoretical, and/or logic models as roadmaps to set the stage for and guide integration
- Analytic strategies that advance frameworks and dynamic processes of connecting, building, merging, embedding, and bridging


Instructor: Alison Hamilton

Alison B. Hamilton, Ph.D., M.P.H., a VA Research Career Scientist and Professor-in-Residence in the UCLA Department of Psychiatry and Biobehavioral Sciences, received her Ph.D. in medical and psychological anthropology from UCLA in 2002, and her M.P.H. in Community Health Sciences from UCLA in 2009. Dr. Hamilton is the Director of the VA-funded EMPOWER (Enhancing Mental and Physical Health of Women through Engagement and Retention) Quality Enhancement Research Initiative (QUERI), focused on improving women Veterans’ health and health care through implementation science. She is the Chief Officer of Implementation & Policy at the VA Health Services Research and Development (HSR&D) Center for the Study of Healthcare Innovation, Implementation and Policy at the VA Greater Los Angeles Healthcare System, specializing in women Veterans’ health, mental health services research, and implementation science.

She is also PI of a large-scale NIH study of enhancing organizational and individual readiness to address cardiovascular risk among individuals living with HIV. She was a fellow in the inaugural cohort of the NIMH/VA Implementation Research Institute and she serves as an Associate Editor for Implementation Science Communications (BMC) and on the editorial boards of Implementation Science (BMC), Women’s Health Issues (Elsevier), and Implementation Research and Practice (Sage).

Dr. Hamilton has been a consultant with ResearchTalk for over 20 years, providing direct support to clients as well as serving as faculty for several of the Qualitative Research Summer Intensives and mentor at ResearchTalk’s Qualitative Methods Camps. At recent Intensives, she has taught courses on qualitative methods in implementation research, rapid qualitative research methods, qualitative grant-writing, qualitative interviewing, integrated mixed methods research, and enhancing the usefulness of qualitative research. Dr. Hamilton is a co-author of Dr. Ray Maietta’s Sort and Sift, Think and Shift (forthcoming, Guilford).

Registration Fees
- UNC-CH Students: $0, with a $35 deposit to hold your spot (deposit is refundable upon your attendance for at least 66% of the course)
- UNC-CH Faculty/Staff/Postdoc: $95
- Non UNC-CH: $145

Additional Course Registration
- Registration will close at 12:01 am on 4/29/2022. Once registration closes, no late registrations will be accepted, no exceptions.
- Cancellation/ Refund Policy: A full refund will be given to those who cancel their registration no later than 10 days prior to the course. If you cancel within 10 days prior to the class, no refund will be given. Please allow 30 days to receive your refund.
- Zoom link for this course will be sent prior to the course. Registration must be made at least 3 days prior to the course date to receive the Zoom link.
- For questions regarding the status of this class, please contact Jill Stevens at This email address is being protected from spambots. You need JavaScript enabled to view it..

Register

Orientation for New Clinical Research Personnel: Spring 2022 - Day 2

Wed. 4 May, 2022 1:00 pm - 3:30 pm

Orientation for New Clinical Research Personnel is returning for Spring 2022! The curriculum is designed to be a true orientation for new research personnel (either new to UNC or new to research altogether), but anyone is welcome to attend. The orientation will be held via Zoom on May 3 and 4, from 1-3:30 p.m. Topics covered in the orientation will include:


- The Research Landscape at UNC Chapel Hill
- The Research Study Life Cycle and Different Types of Research Studies
- Good Clinical Practice
- Overview of Research Regulations and Research Processes
- Overview of Research Roles and Responsibilities
- Informed Consent

Register


Please contact Catherine Barnes at This email address is being protected from spambots. You need JavaScript enabled to view it. if you have questions regarding this training. 

Fri. 6 May, 2022

Odum Institute: Integrated Mixed Methods: Bridging Qualitative and Quantitative Methods and Results - Day 3

Fri. 6 May, 2022 10:00 am - 12:30 pm

This three-day (5/2, 5/4, and 5/6) course will be offered via Zoom. Attendance is required as the course will not be recorded.

Course Summary:

Integrated mixed methods are used to answer questions that necessitate more than one method to achieve a holistic understanding. Combining qualitative and quantitative approaches can enhance conversations about theory, practice, and/or policy. This demanding paradigm requires knowledge, skill, and expertise in quantitative and qualitative methods, as well as the art of intentionally integrating the approaches to and findings from each mode of inquiry.

This course focuses on strategies, tips, and best practices to accomplish integration in accessible and effective ways, including:

- Rationales to guide decision-making related to study design and execution
- Conceptual, theoretical, and/or logic models as roadmaps to set the stage for and guide integration
- Analytic strategies that advance frameworks and dynamic processes of connecting, building, merging, embedding, and bridging


Instructor: Alison Hamilton

Alison B. Hamilton, Ph.D., M.P.H., a VA Research Career Scientist and Professor-in-Residence in the UCLA Department of Psychiatry and Biobehavioral Sciences, received her Ph.D. in medical and psychological anthropology from UCLA in 2002, and her M.P.H. in Community Health Sciences from UCLA in 2009. Dr. Hamilton is the Director of the VA-funded EMPOWER (Enhancing Mental and Physical Health of Women through Engagement and Retention) Quality Enhancement Research Initiative (QUERI), focused on improving women Veterans’ health and health care through implementation science. She is the Chief Officer of Implementation & Policy at the VA Health Services Research and Development (HSR&D) Center for the Study of Healthcare Innovation, Implementation and Policy at the VA Greater Los Angeles Healthcare System, specializing in women Veterans’ health, mental health services research, and implementation science.

She is also PI of a large-scale NIH study of enhancing organizational and individual readiness to address cardiovascular risk among individuals living with HIV. She was a fellow in the inaugural cohort of the NIMH/VA Implementation Research Institute and she serves as an Associate Editor for Implementation Science Communications (BMC) and on the editorial boards of Implementation Science (BMC), Women’s Health Issues (Elsevier), and Implementation Research and Practice (Sage).

Dr. Hamilton has been a consultant with ResearchTalk for over 20 years, providing direct support to clients as well as serving as faculty for several of the Qualitative Research Summer Intensives and mentor at ResearchTalk’s Qualitative Methods Camps. At recent Intensives, she has taught courses on qualitative methods in implementation research, rapid qualitative research methods, qualitative grant-writing, qualitative interviewing, integrated mixed methods research, and enhancing the usefulness of qualitative research. Dr. Hamilton is a co-author of Dr. Ray Maietta’s Sort and Sift, Think and Shift (forthcoming, Guilford).

Registration Fees
- UNC-CH Students: $0, with a $35 deposit to hold your spot (deposit is refundable upon your attendance for at least 66% of the course)
- UNC-CH Faculty/Staff/Postdoc: $95
- Non UNC-CH: $145

Additional Course Registration
- Registration will close at 12:01 am on 4/29/2022. Once registration closes, no late registrations will be accepted, no exceptions.
- Cancellation/ Refund Policy: A full refund will be given to those who cancel their registration no later than 10 days prior to the course. If you cancel within 10 days prior to the class, no refund will be given. Please allow 30 days to receive your refund.
- Zoom link for this course will be sent prior to the course. Registration must be made at least 3 days prior to the course date to receive the Zoom link.
- For questions regarding the status of this class, please contact Jill Stevens at This email address is being protected from spambots. You need JavaScript enabled to view it..

Register

Rethinking Clinical Trials Grand Rounds: N-of-1 Randomized Trials

Fri. 6 May, 2022 1:00 pm - 2:00 pm

N-of-1 Randomized Trials: CRAVE and I-STOP-AFib as Examples (Gregory Marcus, MD, MAS)

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features:

Gregory Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

Learn More

Tue. 10 May, 2022

N3C: Orientation to the N3C Data Enclave - Session A

Tue. 10 May, 2022 11:00 am - 12:30 pm

Join a live training session for the N3C Data Enclave. Users of all types can learn how to navigate the N3C, utilize the Enclave and resources it provides, and learn how to better achieve their analytical goals. This orientation is split into 2 sessions – Session A and Session B. These orientations are offered on a monthly basis. Session A is recommended before attending Session B.

Session A is for those who want to learn about N3C, as well as how to engage with project teams and access the data.

Topics include:

  • Provide a general overview of N3C, including goals, organization, and community resources such as Domain Teams and Data Liaisons.
  • Introduces the 3 data tiers available and important considerations for research driven by the data harmonization process.
  • Discusses resources for training and help, as well as the Data Use Request (DUR) process required for researcher access.

Register

Wed. 11 May, 2022

Machine Learning Tools for Clinical Researchers: A Pragmatic Approach Series

Wed. 11 May, 2022 9:30 am - 11:30 am

This series is jointly sponsored by the UNC Core Center for Clinical Research (CCCR) and the UNC Program for Precision Medicine in Health Care (PPMH). All events will be virtual (Zoom) and free of charge.

The goal of this seminar series is to bring together researchers and clinicians across the UNC campus and catalyze new clinical research using machine learning. All backgrounds and experience levels will find this series engaging and informative.

Machine learning analysis methods offer the opportunity to integrate and learn from large amounts of biological, clinical, and environmental data, and there is a growing interest in how these tools can be used to inform and individualize clinical decision making in a variety of disease areas. Machine learning can offer different, yet often complementary, insights compared to traditional statistical analyses to better understand heterogeneity in patient presentation, prognoses, and treatment response, generating critical data for precision medicine research. These methods can allow integration across diverse data types and large feature sets, overcoming some limitations of traditional tools to answer clinical questions. However, many clinical researchers have little exposure to machine learning methods, presenting a barrier to utilization of these tools themselves and/or to effective collaboration with methodologists in their own research.

The objectives of this series are to:

  • Provide a background/foundation of knowledge regarding the use of machine learning tools in clinical questions
  • Understand the strengths and limitations of these methods
  • Recognize some real-world examples of applied machine learning methodology in clinical research
  • Elucidate how machine learning can be used to advance precision medicine research

On May 11, 2022, from 9:30-11:30 a.m., clinicians and researchers will discuss examples of how machine learning tools have been applied in arthritis and autoimmune disease. This session will feature an overview of machine learning and its application to identify clinical phenotypes of osteoarthritis and type 1 diabetes.

On May 18, 2022, from 1:00-3:00 p.m., clinicians and researchers will explore the use of machine learning tools and precision medicine techniques in clinical research. This session will feature an overview of machine learning tools in the field of precision medicine and address how they may be used to inform decision support for peripheral artery disease and rare genetic diseases.

On May 25, 2022, from 1:00-3:00 p.m., a panel discussion will focus on how researchers and clinicians at UNC can integrate machine learning techniques into their own clinical research. Are you a clinician with an idea for how patient care could be improved with computational decision support tools? Pitch your idea (5-10 minute overview) to assembled machine learning experts on May 25. Receive expert guidance and compete for funding from the UNC Program for Precision Medicine in Health Care for analytical support to develop your project. Email This email address is being protected from spambots. You need JavaScript enabled to view it. for more information about the pitch opportunity.

We encourage anyone interested in using machine learning as part of their own research to attend, regardless of research background or experience with machine learning!

Register

Fri. 13 May, 2022

Rethinking Clinical Trials Grand Rounds: Ethics and Collateral Findings in Pragmatic Clinical Trials

Fri. 13 May, 2022 1:00 pm - 2:00 pm

Ethics and Collateral Findings in Pragmatic Clinical Trials: Implications of a Multi-Method Exploration

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features:

Jeremy Sugarman, MD, MPH, MA
Deputy Director for Medicine
Harvey M. Meyerhoff Professor of Bioethics and Medicine
Berman Institute of Bioethics
Johns Hopkins University

Stephanie Morain, PhD, MPH
Assistant Professor
Berman Institute of Bioethics
Johns Hopkins University

Juli Bollinger, MS
Research Scientist
Berman Institute of Bioethics
Johns Hopkins University

Kevin P. Weinfurt, PhD
Professor and Vice Chair of Research
Department of Population Health Sciences
Duke University School of Medicine

Learn More

Mon. 16 May, 2022

Nutrition Research Institute: Nutrigenetics, Nutrigenomics and Precision Nutrition Short Course

Mon. 16 May, 2022 12:00 am - Thu. 19 May, 2022 11:59 pm

This course delivers fundamental NGx concepts and addresses barriers that impede translation of research results from laboratories to people by bringing together researchers and practitioners in NGx concepts ranging from cell biology to dietetics. Designed for graduate students, health professionals and nutrition scientists from academia, agencies, and industry.

Presented by: UNC Nutrition Research Institute (NRI) and UNC Nutrition and Obesity Research Center (NORC)

Goals

  • Educate current and future NGx researchers
  • Provide cutting-edge research directions and methodologies in NGx
  • Bring together students, postdocs, faculty (basic scientists and translational researchers), industry researchers and clinicians in an inclusive virtual environment to foster interactions and networking

Features

  • Unique – Participants can send their saliva samples in advance to be genotyped for more than 300,000 SNPs. You must register on or before March 1, 2022 and be a US resident to use this program feature.
  • Keynote address, 16 lectures, and 2 hands-on workshops
  • Registered Dietitians can earn up to 24.5 CPEUs for this course, if all sessions are attended.

Presenters are from departments of Nutrition, Genetics, Epidemiology, Psychology and Neuroscience, School of Pharmacy, and the Nutrition Research Institute at UNC-Chapel Hill; UNC Charlotte; Western Human Nutrition Research Center, USDA-ARS; Instituto Nacional de Medicina Genomica; University of Illinois; and Baylor College of Medicine USDA/ARS Children’s Nutrition Research Center.

Attendees

The NRI has produced this short course annually since 2016 (with the exception of 2020 due to the pandemic) with attendees and presenters from around the world. Annual attendance is capped at 80 and past attendees have included graduate students, postdocs, faculty, industry researchers, physicians, and registered dietitians.

Registration and Fees

Registration fees include accommodations, see details below.

  • $850 General
  • $600 Postdoc
  • $500 Graduate student

NGx will be held at the Embassy Suites by Hilton Charlotte Concord Golf Resort & Spa. Registration fees include the full conference and a single room in the hotel for the nights of 5/15 – 5/18, as well as continental breakfast, lunch, and dinner daily (no dinner on 5/19). Also included is transportation between event venues during the short course. Transportation to and from the conference is not included.

Keynote Speaker

Robert A. Waterland, PhD is a professor in the Department of Pediatrics and the Department of Molecular & Human Genetics at Baylor College of Medicine USDA/ARS Children’s Nutrition Research Center.

Register

Regulatory Fitness in Rare Disease Clinical Trials - Day 1

Mon. 16 May, 2022 9:00 am - 4:00 pm

Overview

On May 16 and 17, 2022, the National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) will host a jointly sponsored virtual workshop to explore Regulatory Fitness in Rare Disease Clinical Trials.

Advances in rare diseases, particularly in the field of genetics, result in an active, highly innovative, and rapidly evolving area of science and drug development. Nonetheless, rare disease drug development represents an area of high unmet medical need. There are many challenges in rare disease drug development that are broadly recognized by the rare disease drug development community, such as:

  • The large number of different rare diseases (more than 7,000)
  • The small number of patients with the individual disorders which can make clinical trial design and interpretation challenging
  • The lack of drug development precedent for most rare diseases
  • The lack of established endpoints, including biomarkers and clinical outcome measures, for some rare disease clinical trials

Academic investigators, patient groups, and small or emerging pharmaceutical and biotechnology companies play a critical role in rare disease drug development and are often the sponsors for rare disease drug development, but they may lack regulatory experience. This workshop focuses on academic investigators and those looking to learn how to bridge the gap between academic investigation and the regulatory aspects of drug development.

This workshop will:

  • Provide lessons on the fundamentals of drug development and discuss rare disease case studies shared by academic investigators
  • Share experiences and expertise from multi-disciplinary stakeholders
  • Discuss regulatory considerations for rare disease clinical trials
  • Explore topics such as:
    - Adequate and well-controlled trials
    - Core principles for clinical trials
    - The nuts and bolts of Investigational New Drug (IND) applications and additional considerations
    - Additional pathways to interact with the FDAM
    - Case studies
  • Participation in this workshop will allow attendees to improve their familiarity and understanding of Federal regulations, guidelines, and approaches for good quality rare disease clinical trials. While specific questions about applications will not be addressed, topics in general will be discussed and case studies will be presented as learning examples.

    For more information about the event, please click here.

    Register

Tue. 17 May, 2022

Nutrition Research Institute: Nutrigenetics, Nutrigenomics and Precision Nutrition Short Course

Mon. 16 May, 2022 12:00 am - Thu. 19 May, 2022 11:59 pm

This course delivers fundamental NGx concepts and addresses barriers that impede translation of research results from laboratories to people by bringing together researchers and practitioners in NGx concepts ranging from cell biology to dietetics. Designed for graduate students, health professionals and nutrition scientists from academia, agencies, and industry.

Presented by: UNC Nutrition Research Institute (NRI) and UNC Nutrition and Obesity Research Center (NORC)

Goals

  • Educate current and future NGx researchers
  • Provide cutting-edge research directions and methodologies in NGx
  • Bring together students, postdocs, faculty (basic scientists and translational researchers), industry researchers and clinicians in an inclusive virtual environment to foster interactions and networking

Features

  • Unique – Participants can send their saliva samples in advance to be genotyped for more than 300,000 SNPs. You must register on or before March 1, 2022 and be a US resident to use this program feature.
  • Keynote address, 16 lectures, and 2 hands-on workshops
  • Registered Dietitians can earn up to 24.5 CPEUs for this course, if all sessions are attended.

Presenters are from departments of Nutrition, Genetics, Epidemiology, Psychology and Neuroscience, School of Pharmacy, and the Nutrition Research Institute at UNC-Chapel Hill; UNC Charlotte; Western Human Nutrition Research Center, USDA-ARS; Instituto Nacional de Medicina Genomica; University of Illinois; and Baylor College of Medicine USDA/ARS Children’s Nutrition Research Center.

Attendees

The NRI has produced this short course annually since 2016 (with the exception of 2020 due to the pandemic) with attendees and presenters from around the world. Annual attendance is capped at 80 and past attendees have included graduate students, postdocs, faculty, industry researchers, physicians, and registered dietitians.

Registration and Fees

Registration fees include accommodations, see details below.

  • $850 General
  • $600 Postdoc
  • $500 Graduate student

NGx will be held at the Embassy Suites by Hilton Charlotte Concord Golf Resort & Spa. Registration fees include the full conference and a single room in the hotel for the nights of 5/15 – 5/18, as well as continental breakfast, lunch, and dinner daily (no dinner on 5/19). Also included is transportation between event venues during the short course. Transportation to and from the conference is not included.

Keynote Speaker

Robert A. Waterland, PhD is a professor in the Department of Pediatrics and the Department of Molecular & Human Genetics at Baylor College of Medicine USDA/ARS Children’s Nutrition Research Center.

Register

Regulatory Fitness in Rare Disease Clinical Trials - Day 2

Tue. 17 May, 2022 9:00 am - 12:00 pm

Overview

On May 16 and 17, 2022, the National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) will host a jointly sponsored virtual workshop to explore Regulatory Fitness in Rare Disease Clinical Trials.

Advances in rare diseases, particularly in the field of genetics, result in an active, highly innovative, and rapidly evolving area of science and drug development. Nonetheless, rare disease drug development represents an area of high unmet medical need. There are many challenges in rare disease drug development that are broadly recognized by the rare disease drug development community, such as:

  • The large number of different rare diseases (more than 7,000)
  • The small number of patients with the individual disorders which can make clinical trial design and interpretation challenging
  • The lack of drug development precedent for most rare diseases
  • The lack of established endpoints, including biomarkers and clinical outcome measures, for some rare disease clinical trials

Academic investigators, patient groups, and small or emerging pharmaceutical and biotechnology companies play a critical role in rare disease drug development and are often the sponsors for rare disease drug development, but they may lack regulatory experience. This workshop focuses on academic investigators and those looking to learn how to bridge the gap between academic investigation and the regulatory aspects of drug development.

This workshop will:

  • Provide lessons on the fundamentals of drug development and discuss rare disease case studies shared by academic investigators
  • Share experiences and expertise from multi-disciplinary stakeholders
  • Discuss regulatory considerations for rare disease clinical trials
  • Explore topics such as:
    - Adequate and well-controlled trials
    - Core principles for clinical trials
    - The nuts and bolts of Investigational New Drug (IND) applications and additional considerations
    - Additional pathways to interact with the FDAM
    - Case studies
  • Participation in this workshop will allow attendees to improve their familiarity and understanding of Federal regulations, guidelines, and approaches for good quality rare disease clinical trials. While specific questions about applications will not be addressed, topics in general will be discussed and case studies will be presented as learning examples.

    For more information about the event, please click here.

    Register

Qualitative Research 101

Tue. 17 May, 2022 10:00 am - 12:00 pm

This online training session will provide an introduction to qualitative research methods. Participants will have the opportunity to ask questions and share experiences conducting qualitative research.

Topics:

  • Differences between quantitative and qualitative research
  • Qualitative research methodologies
  • Strategies for qualitative data collection
  • Methods of qualitative data analysis

Presenter:
MaryBeth Grewe, MPH, NC TraCS Community and Stakeholder Engagement Program Qualitative Research Specialist

Register

 

Wed. 18 May, 2022

Nutrition Research Institute: Nutrigenetics, Nutrigenomics and Precision Nutrition Short Course

Mon. 16 May, 2022 12:00 am - Thu. 19 May, 2022 11:59 pm

This course delivers fundamental NGx concepts and addresses barriers that impede translation of research results from laboratories to people by bringing together researchers and practitioners in NGx concepts ranging from cell biology to dietetics. Designed for graduate students, health professionals and nutrition scientists from academia, agencies, and industry.

Presented by: UNC Nutrition Research Institute (NRI) and UNC Nutrition and Obesity Research Center (NORC)

Goals

  • Educate current and future NGx researchers
  • Provide cutting-edge research directions and methodologies in NGx
  • Bring together students, postdocs, faculty (basic scientists and translational researchers), industry researchers and clinicians in an inclusive virtual environment to foster interactions and networking

Features

  • Unique – Participants can send their saliva samples in advance to be genotyped for more than 300,000 SNPs. You must register on or before March 1, 2022 and be a US resident to use this program feature.
  • Keynote address, 16 lectures, and 2 hands-on workshops
  • Registered Dietitians can earn up to 24.5 CPEUs for this course, if all sessions are attended.

Presenters are from departments of Nutrition, Genetics, Epidemiology, Psychology and Neuroscience, School of Pharmacy, and the Nutrition Research Institute at UNC-Chapel Hill; UNC Charlotte; Western Human Nutrition Research Center, USDA-ARS; Instituto Nacional de Medicina Genomica; University of Illinois; and Baylor College of Medicine USDA/ARS Children’s Nutrition Research Center.

Attendees

The NRI has produced this short course annually since 2016 (with the exception of 2020 due to the pandemic) with attendees and presenters from around the world. Annual attendance is capped at 80 and past attendees have included graduate students, postdocs, faculty, industry researchers, physicians, and registered dietitians.

Registration and Fees

Registration fees include accommodations, see details below.

  • $850 General
  • $600 Postdoc
  • $500 Graduate student

NGx will be held at the Embassy Suites by Hilton Charlotte Concord Golf Resort & Spa. Registration fees include the full conference and a single room in the hotel for the nights of 5/15 – 5/18, as well as continental breakfast, lunch, and dinner daily (no dinner on 5/19). Also included is transportation between event venues during the short course. Transportation to and from the conference is not included.

Keynote Speaker

Robert A. Waterland, PhD is a professor in the Department of Pediatrics and the Department of Molecular & Human Genetics at Baylor College of Medicine USDA/ARS Children’s Nutrition Research Center.

Register

NRP: Step Into Your Moxie - Move People to Take Action

Wed. 18 May, 2022 9:00 am - 10:00 am

UNC Researcher Appreciation Week 2022

In celebration of the NRP’s 10th Anniversary and Clinical Trials Day 2022, we are pleased to offer several events and education sessions in appreciation of everything you do!

Cultivate the confidence, strategy, and communication skills to be dynamic persuasive communicators who more easily speak up for themselves, their ideas, and their companies. They develop the ability to manage fear and self-defeating thoughts connected to "going for the yes," and learn how to address other people's objections by staying flexible, listener-centered, and on message.

This session is free and open to all UNC researchers, research professionals, and research staff.

Presenter:

Alexia Vernon, Founder and President of Step Into Your Moxie

Register

To learn more about NRP Researcher Appreciation Week and its other events, please click here. If you have any questions regarding this event, please contact Emily Olsson at This email address is being protected from spambots. You need JavaScript enabled to view it.

Teatime with NCATS Acting Director Joni Rutter

Wed. 18 May, 2022 1:30 pm - 2:15 pm

Join NCATS for an inaugural stakeholder “teatime” discussion. This event is an opportunity for supporters, advocates, and educators to participate in a discussion on the status of NCATS as they approach the May 19–20 NCATS Advisory Council meeting.

The 45-minute event will feature a short presentation from Joni L. Rutter, PhD, NCATS acting director, followed by a conversation moderated by Esther Krofah, MPP, executive director of FasterCures and the Center for Public Health at the Milken Institute, about how we can build relationships, raise awareness and work together to advance the mission of NCATS.

Register

CRSO: The Mechanics of Investigator Initiated Trials

Wed. 18 May, 2022 4:00 pm - 5:00 pm

Join NC TraCS and the SOM CRSO for a presentation for current and future Principal Investigators on Investigator-Initiated Trials (IIT). Susan Pusek, the Director of Education Programs for NC TraCS, will present on definition, design, and regulatory considerations of an IIT, finding sponsors and funding for IITs, and the role of IITs in investigator career development. Zoom information will be provided to participants after registration.

Register

Thu. 19 May, 2022

Nutrition Research Institute: Nutrigenetics, Nutrigenomics and Precision Nutrition Short Course

Mon. 16 May, 2022 12:00 am - Thu. 19 May, 2022 11:59 pm

This course delivers fundamental NGx concepts and addresses barriers that impede translation of research results from laboratories to people by bringing together researchers and practitioners in NGx concepts ranging from cell biology to dietetics. Designed for graduate students, health professionals and nutrition scientists from academia, agencies, and industry.

Presented by: UNC Nutrition Research Institute (NRI) and UNC Nutrition and Obesity Research Center (NORC)

Goals

  • Educate current and future NGx researchers
  • Provide cutting-edge research directions and methodologies in NGx
  • Bring together students, postdocs, faculty (basic scientists and translational researchers), industry researchers and clinicians in an inclusive virtual environment to foster interactions and networking

Features

  • Unique – Participants can send their saliva samples in advance to be genotyped for more than 300,000 SNPs. You must register on or before March 1, 2022 and be a US resident to use this program feature.
  • Keynote address, 16 lectures, and 2 hands-on workshops
  • Registered Dietitians can earn up to 24.5 CPEUs for this course, if all sessions are attended.

Presenters are from departments of Nutrition, Genetics, Epidemiology, Psychology and Neuroscience, School of Pharmacy, and the Nutrition Research Institute at UNC-Chapel Hill; UNC Charlotte; Western Human Nutrition Research Center, USDA-ARS; Instituto Nacional de Medicina Genomica; University of Illinois; and Baylor College of Medicine USDA/ARS Children’s Nutrition Research Center.

Attendees

The NRI has produced this short course annually since 2016 (with the exception of 2020 due to the pandemic) with attendees and presenters from around the world. Annual attendance is capped at 80 and past attendees have included graduate students, postdocs, faculty, industry researchers, physicians, and registered dietitians.

Registration and Fees

Registration fees include accommodations, see details below.

  • $850 General
  • $600 Postdoc
  • $500 Graduate student

NGx will be held at the Embassy Suites by Hilton Charlotte Concord Golf Resort & Spa. Registration fees include the full conference and a single room in the hotel for the nights of 5/15 – 5/18, as well as continental breakfast, lunch, and dinner daily (no dinner on 5/19). Also included is transportation between event venues during the short course. Transportation to and from the conference is not included.

Keynote Speaker

Robert A. Waterland, PhD is a professor in the Department of Pediatrics and the Department of Molecular & Human Genetics at Baylor College of Medicine USDA/ARS Children’s Nutrition Research Center.

Register

NRP: From CRC to VP - A Professional Path

Thu. 19 May, 2022 12:00 pm - 1:00 pm

UNC Researcher Appreciation Week 2022

In celebration of the NRP’s 10th Anniversary and Clinical Trials Day 2022, we are pleased to offer several events and education sessions in appreciation of everything you do!

Quincy Byrdsong, EdD, CIP, CCRP, will discuss how research staff can leverage the multi-faceted nature of clinical research to launch career development opportunities that contribute to either clinical research, industry, or academia at the highest level.

This session is free and open to all UNC researchers, research professionals, and research staff.

Presenter:

Quincy Byrdsong, EdD, CIP, CCRP
Vice Provost for Health Sciences at Lipscomb University
Immediate Past President Society of Clinical Research Associates

Register

To learn more about NRP Researcher Appreciation Week and its other events, please click here. If you have any questions regarding this event, please contact Emily Olsson at This email address is being protected from spambots. You need JavaScript enabled to view it.

Fri. 20 May, 2022

NRP: Creating Connections Workshop

Fri. 20 May, 2022 10:00 am - 12:00 pm

UNC Researcher Appreciation Week 2022

In celebration of the NRP’s 10th Anniversary and Clinical Trials Day 2022, we are pleased to offer several events and education sessions in appreciation of everything you do!

Creating Connections Workshop: Presented by the Alan Alda Center for Communicating Science

"Creating Connections: An Introduction to the Alda Method" is a two-hour live, online workshop designed to help scientists and researchers learn to engage and inspire diverse audiences through effective communication, with a particular focus on virtual interactions. Participants will learn how to balance being prepared with responding at the moment to address questions. The program emphasizes universal communication strategies, including avoiding jargon, and technical skills for creating engagement online, including camera angles and sound levels.

This is not your standard communication training...the workshop combines group and partner exercises with audience-centered messaging tools to help researchers speak about their science in a way that builds trust and inspires listeners. It is an experience like no other that allows participants to engage with their colleagues and Alda Center faculty to focus on listening, connecting, and knowing their audience. This is a collaborative experience; participants will need to have cameras and microphones on and be ready to participate in a virtual session like no other!

Event activities are geared toward Career Research Professionals (e.g. coordinators/project managers, etc, with several years' experience) and Research Faculty (any career level) working on complex projects or in technical therapeutic areas. Please come prepared with a specific project or scientific/research focus for the workshop.

Register

To learn more about NRP Researcher Appreciation Week and its other events, please click here. If you have any questions regarding this event, please contact Emily Olsson at This email address is being protected from spambots. You need JavaScript enabled to view it.

Tue. 24 May, 2022

Semi-Structured Interviewing

Tue. 24 May, 2022 10:00 am - 12:00 pm

This interactive online workshop will focus on semi-structured interviewing, a data collection method used in qualitative research. Participants will have the opportunity to practice developing interview questions and using interviewing skills.

Topics:

  • Basics of semi-structured interviews
  • Development of interview questions and probes
  • Interviewing skills
  • Considerations for conducting virtual interviews.

Presenters:
MaryBeth Grewe, MPH, NC TraCS Community and Stakeholder Engagement Program Qualitative Research Specialist
Simone Frank, MPH, Engagement and Outreach Coordinator, of the NC TraCS Community and Stakeholder Engagement Program

Register

 

N3C: Orientation to the N3C Data Enclave - Session B

Tue. 24 May, 2022 11:00 am - 12:30 pm

Join a live training session for the N3C Data Enclave. Users of all types can learn how to navigate the N3C, utilize the Enclave and resources it provides, and learn how to better achieve their analytical goals. This orientation is split into 2 sessions – Session A and Session B. These orientations are offered on a monthly basis. Session A is recommended before attending Session B.

Session B is for analysts, statisticians, data scientists, or anyone who wants to gain a broader understanding of the tools needed to work with the data.

Topics include:

  • Focus on technical aspects of working with data in the secure N3C Enclave, including use of OMOP concept sets and N3C-specific tooling, such as the Concept Set Browser.
  • Introduce commonly used analysis tools, such as Contour and Code Workbooks and corresponding workflows for simple analyses.
  • Introduce the Enclave Knowledge Store, a mechanism for sharing and using community-developed code and data across projects.

Register

Wed. 25 May, 2022

Community-Based Approaches to Promoting Behavioral Health Equity

Wed. 25 May, 2022 4:00 pm - 6:00 pm

Community-Based Approaches to Promoting Behavioral Health Equity: A Call to Action

The UMass CCTS in partnership with the Georgia, UC Davis, and Florida CTSAs are pleased to announce a CROSS-CTSA SPECIAL SEMINAR: Community-Based Approaches to Promoting Behavioral Health Equity: A Call to Action.

Hear from the experts about their work related to community-engaged interventions that promote behavioral health equity, the role of community/patient engagement in advancing behavioral health research as well as community perspectives.

Register

Thu. 26 May, 2022

Carolina Data Science Now: Improving Health Outcomes

Thu. 26 May, 2022 12:00 pm - 1:00 pm

Please join Carolina Data Science Now for “Improving Health Outcomes”. The event will feature three lightning talks by professors and researchers in UNC-Chapel Hill’s academic community.

These talks will be followed by a guided panel, an opportunity for questions and answers with the speakers, and a discussion with the data science community at UNC-Chapel Hill.

Register

Tue. 31 May, 2022

Introduction to Focus Groups

Tue. 31 May, 2022 10:00 am - 12:00 pm

This event is currently closed due to hitting max capacity. A waitlist is available.

This interactive online workshop will provide an introduction to focus groups, a data collection method used in qualitative research. Attendees will also participate in a mini "mock" virtual focus group session.

Topics:

  • Focus group methodology
  • Considerations for planning a focus group
  • Development of focus group discussion guides
  • Focus group facilitation skills
  • Tips for conducting virtual focus groups

Presenters:
MaryBeth Grewe, MPH, NC TraCS Community and Stakeholder Engagement Program Qualitative Research Specialist
Simone Frank, MPH, Engagement and Outreach Coordinator, of the NC TraCS Community and Stakeholder Engagement Program

Register

UNC CFAR: Research as an MPI

Tue. 31 May, 2022 3:00 pm - 4:00 pm

The UNC CFAR Developmental Core is partnering with FHI 360 on an upcoming Zoom presentation featuring Allysha C. Maragh-Bass, PhD, MPH (FHI 360) and Benjamin Chi, MD, MSc (UNC). This discussion will focus on how to apply for funding and function as part of a multiple principal investigators (multi-PI) team.

As an Early Stage Investigator (ESI), Maragh-Bass has already worked as an MPI on the joint UNC-Duke CFAR Developmental Cohort-FHI 360 Award and has recently put in an application with MPIs to the NIH. Her work is domestic; Chi’s is international and he has frequently been part of MPI teams.

No registration is required. If you have any questions regarding MPI projects, please send them to Cathy Emrick at This email address is being protected from spambots. You need JavaScript enabled to view it. so that the speakers will have a chance to include answers in their presentations. Attendees will also have a chance to ask questions during the meeting.

Zoom

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