Lessons from COVID-19: The First Year of the REMAP-CAP Global Adaptive Platform Trial

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Derek C. Angus, MD, MPH, FRCP of University of Pittsburgh Medical Center and University of Pittsburgh Schools of the Health Sciences.

Presenters
Derek C. Angus, MD, MPH, FRCP
Chief Healthcare Innovation Officer, UPMC
Associate Vice Chancellor for Healthcare Innovation, University of Pittsburgh Schools of the Health Sciences
Distinguished Professor and Mitchell P. Fink Endowed Chair
Department of Critical Care Medicine, University of Pittsburgh and UPMC

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The 2021 Translational Medicine Symposium is co-sponsored by the Program in Translational Medicine and the Cancer Cell Biology Training Program. This year’s symposium will include Zoom sessions and Gathertown spaces.

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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 ongoing and will alternate week by week. 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.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

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Implementation Science in Global Health: Leveraging the Power of Community

Join NC TraCS and the Center for AIDS Research for the Spring 2021 edition of the Implementation Science Speaker Series, featuring Carolyn Audet, PhD, Assistant Professor of Health Policy and Epidemiology and Assistant Director of Community Based Implementation Research at Vanderbilt University.

In this seminar, Audet will discuss engagement of traditional healers in the delivery of evidence-based HIV testing and treatment support in rural South Africa. She will cover the process of adapting evidence-based interventions; assessing strategy acceptability, feasibility and appropriateness; and documentation of implementation fidelity. Finally, Audet will share about the benefits of creating strong relationships with study communities and the obligations researchers have to their in-country partners.

Presenter

Carolyn Audet, PhD
Assistant Professor, Vanderbilt University

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This six-part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The series will introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. It is recommended that registrants complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation.

Each session of the orientation will be held on Wednesday afternoons,1:30 to 4:30 pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered this week include:

• Contracts and Clinical Trial Agreements (Vonzell Jones) - 1:30 pm - 2:10 pm
• Billing Coverage Analysis overview (Andrea Eiring ) - 2:10 pm - 2:50 pm
• Budgeting for Clinical Research, Accounting of Funds (Jill Cunnup) - 2:55 pm - 3:15 pm
• Preparing and Executing NIH Grant Budgets (Sandy Barnhart) - 3:15 pm - 4:00 pm
• Post-Session Q&A Discussion 4:00 pm - 4:30 pm

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CTSA Visiting Scholar — Therapeutic Advances in Hereditary Hemorrhagic Telangiectasia

Hereditary hemorrhagic telangiectasia (HHT) is a rare, hereditary multisystem vascular disease of disordered angiogenesis. Pathologic elevations in vascular endothelial growth factor (VEGF) result in fragile, abnormal vessels in nasal and GI mucosa leading to chronic epistaxis and GI bleeding, anemia that is frequently severe and transfusion-dependent, and diminished quality of life.

Bevacizumab is a recombinant, humanized monoclonal IgG1 antibody that neutralizes circulating VEGF and is a potential targeted therapy in HHT. Hanny Al-Samkari, MD will describe the revolutionary potential of anti-angiogenic therapy in HHT and the evidence to date for systemic bevacizumab as a treatment for bleeding and anemia in HHT.

Presenter:
Hanny Al-Samkari, MD
Division of Hematology/Oncology, Massachusetts General Hospital
Instructor in Medicine and KL2 Scholar, Harvard Medical School

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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 ongoing and will alternate week by week. 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.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

Register

Machine Learning Seminar Series: The Promise and Peril of Machine Learning in Clinical Research

In this session of the Machine Learning Seminar series, Michele Jonsson-Funk, PhD, will introduce Machine Learning concepts and the potential implications of using Machine Learning for clinical research.

Presenter
Michele Jonsson-Funk, PhD
Associate Professor of Epidemiology
Director of the Center for Pharmacoepidemiology
UNC-Chapel Hill

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The REDCap Forms Training Session will teach users to build forms using the online designer or data dictionary (lecture/demo).

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

Understanding the Association Between Hearing Loss and Falls: Current Perspectives and Future Directions

Falls and falls-related injuries result in substantial morbidity, mortality, and disability among older adults. This presentation will discuss current knowledge on the association between sensorineural hearing loss & falls as well as a proposed mechanistic model. Preliminary results on whether the association is modified by hearing healthcare intervention (i.e. hearing aids and/or cochlear implants) will also be discussed.

Presenter
Kristal M. Riska, AuD, PhD
Assistant Professor
Department of Head and Neck Surgery & Communication Sciences
Duke University School of Medicine

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This six-part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The series will introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. It is recommended that registrants complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation.

Each session of the orientation will be held on Wednesday afternoons,1:30 to 4:30pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered this week include:

• Study Start Up and Roles of Research Personnel (Laura Viera) - 1:30 pm - 2:25 pm
• Recruitment Services / Carolina Data Warehouse (Emily Olsson) - 2:30 pm - 3:30 pm
• UNC Hospitals Investigational Drug Services (Andrew Thorne) - 3:35 - 4:00pm
• Hospital Device Management Policy (Marie Rape) - 4:00 pm
• Post-Session Q&A Discussion 4:00 pm - 4:30 pm

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This is an online 3-part short course (held over three afternoons - 4/14, 4/15, 4/16 ) offered by the Odum Institute. Stata part 1 will offer an introduction to Stata basics. Part 2 will teach entering data in Stata, working with Stata do files, and will show how to append, sort, and merge data sets. Part 3 will cover how to perform basic statistical procedures and regression models in Stata.

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When you attend the Innovation Showcase hosted by Innovate Carolina, you meet the most enterprising innovators from UNC-Chapel Hill and the local entrepreneurial community. Celebrate the work of UNC-Chapel Hill faculty, students, alumni and local business founders who have combined ingenuity and hard work to make a human and economic impact.

Chancellor Kevin Guskiewicz, Chapel Hill Mayor Pam Hemminger and other leaders will kick off a special celebration: the 10-year anniversary of the Innovate Carolina roadmap, which established today’s active network of people and programs that help innovators and ventures make their ideas work.

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Adam Lee from NC TraCS and Stephanie Deen from UNC Health will be presenting on EPIC Updates and Health Informatics. They will provide an overview and success stories of using myUNCchart (myChart) for patient recruitment, review Epic@UNC security and feature updates and enhancements, and provide an overview and use cases for Best Practice Advisories within Epic for research studies.

Attendance at this event is pending approval for 1 contact hour of clinical research education on applications for Maintenance of ACRP's CCRC®, CCRA®, CPI® or ACRP-CP® certification designations

Presenters: Adam Lee (NC TraCS) and Stephanie Deen (UNC Health)

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This is an online 3-part short course (held over three afternoons - 4/14, 4/15, 4/16 ) offered by the Odum Institute. Stata part 1 will offer an introduction to Stata basics. Part 2 will teach entering data in Stata, working with Stata do files, and will show how to append, sort, and merge data sets. Part 3 will cover how to perform basic statistical procedures and regression models in Stata.

Learn More

This is an online 3-part short course (held over three afternoons - 4/14, 4/15, 4/16 ) offered by the Odum Institute. Stata part 1 will offer an introduction to Stata basics. Part 2 will teach entering data in Stata, working with Stata do files, and will show how to append, sort, and merge data sets. Part 3 will cover how to perform basic statistical procedures and regression models in Stata.

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PCORI Applicant Town Hall: Increasing Vaccine Confidence among Long-Term Care Workers (Expedited COVID-19 PFA)

This town hall will provide an overview of PCORI and the information applicants may need to submit a responsive application to the Increasing Vaccine Confidence among Long-Term Care Workers: Expedited COVID-19 Targeted PCORI Funding Announcement (PFA).

The targeted PFA will open on Tuesday, April 13, 2021. Applications will be due Tuesday, May 4, 2021 at 5pm ET.

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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 ongoing and will alternate week by week. 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.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

Register

Please join the Office of Clinical Trials for a virtual town hall to learn about several initiatives underway to improve clinical research at UNC. Topics to be discussed will include: processes to reduce administrative burden, changes to the research fee schedule, remote consent options, subject injury language, and an update on OnCore Enterprise.

Register

The REDCap Hands-On Form Building Training Session will teach users to build forms using the online designer or data dictionary. This session will be a click along hands-on/lecture/demo.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

Machine Learning Seminar Series: Use Cases for Machine Learning – From predicting out-of-hospital deaths in claims data to identifying novel side effects of drugs using social media

In this session of the Machine Learning Seminar series, Nabarun Dasgupta, MPH, PhD, will provide an overview of Machine Learning vs Natural Language Processing. Dasgupta will discuss three examples of how he has utilized Machine Learning in research – from using an algorithm to predict out-of-hospital deaths in claims data to using Machine Learning to conduct systematic review searches.

Presenter
Nabarun Dasgupta, MPH, PhD
Innovation Fellow, Gillings School of Global Public Health
Senior Scientist, Injury Prevention Research Center
UNC-Chapel Hill

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When working with data, one thing is fairly certain: data is rarely in an optimal format. A misplaced space here, or an extra comma there, can mean the difference between two clicks and two hours of work. In this course, we will work with ways to isolate, extract, and transform data from webpages, text files, and published datasets using Python and Pandas. This Odum Institute class will also introduce regular expressions, a language for matching specific parts of text.

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This six-part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The series will introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. It is recommended that registrants complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation.

Each session of the orientation will be held on Wednesday afternoons,1:30 to 4:30 pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered this week include:

• Introduction to REDCap (Clarence Potter) - 1:30 pm - 2:00 pm
• Investigator-Initiated Study Processes (Valorie Buchholz) - 2:05 pm - 2:35 pm
• ClinicalTrials.gov and ICMJE requirements (Monica Coudurier) - 2:40 pm - 3:20 pm
• Adverse Event Evaluation and Documentation (Marie Rape) - 3:20 pm - 3:50 pm
• IND and IDE Studies at UNC (Marie Rape) - 3:50 pm - 4:00 pm
• Post-Session Q&A Discussion 4:00 pm - 4:30 pm

Register

CRO Career Conversations: Clinical Research Coordinator

This panel discussion will highlight the role of Clinical Research Coordinators (CRCs). Learn about the aspects of clinical research that CRCs support including subject screening and recruitment, regulatory maintenance, data collection, and data management activities.

Panelists from NC TraCS include:

Susan Pusek, DRSc
Moderator
Director, Education Programs

Susan Pusek, DRSc has over 27 years of experience in clinical/translational research, training and administration. She began her career as a research coordinator and project manager for industry-sponsored, federally-funded and investigator-initiated phase I-IV clinical trials, health services research done in the community and epidemiologic studies. In her current role as Director of Education Programs at NC TraCS, Pusek now develops training programs, seminars and workshops for biomedical researchers and their teams.

Catherine Barnes
Personnel Development and Training Specialist
UNC Clinical Research Support Office (CRSO)

Catherine Barnes has over 5 years of experience in conducting and managing human subjects research, and is a Certified Clinical Research Professional through SOCRA. She also creates and manages various education sessions for research personnel, including topics like informed consent, source documentation management, phlebotomy and others. Her primary interests revolve around the education and retention of research personnel to ensure that they feel happy in their positions while growing professionally and personally.

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Contract research organizations (CRO) operate in many capacities to support the work of healthcare innovators and help move therapies from idea to market. NC Biotech’s CRO Career Conversations speaker series provides an introduction to key roles within the CRO industry and the opportunity to learn about career pathways, day-to-day responsibilities, and more from professionals currently in the field.

REDCap Functions is advanced training in using functions with your project such as Surveys, Randomization, Calendar/Scheduling, etc.

The session will cover Imports, Reusing Forms, Exports, Surveys, Data Quality Checks, Collecting Data Offline (REDCap Mobile), Subject App (MyCap), Pulling Epic Data, Special layouts (Shazam), Multiple Languages, and more.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced*)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

COVID Clinical Trials: The Intermountain Healthcare Experience

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Samuel M. Brown, MD, MS of Intermountain Healthcare and the University of Utah.

Presenters
Samuel M. Brown, MD, MS
Associate Professor and Director of Pulmonary/Critical Care Research
Intermountain Healthcare
Associate Professor, University of Utah

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Machine Learning Seminar Series: Introduction to CLARK 1.0 and 2.0

In this session of the Machine Learning Seminar series, Buck Bohac, PhD, will walk attendees through the process of using CLARK! and regular expressions for clinical research. CLARK! is a machine-learning classifier developed through a collaboration between NC TraCS and CoVar Applied Technologies, a Durham, NC-based machine learning company. CLARK! is designed to take clinical notes as input, and classify those notes based on features defined by the user as regular expressions.

Presenter
Buck Bohac, PhD
NC TraCS Data Analyst and Applications Specialist

Register

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 ongoing and will alternate week by week. 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.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

Register

The REDCap Open Training Session will review using surveys and provide ample time to answer any questions REDCap users might have.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

Join this month's COVID-19 journal club to discuss recent safety signals of the AstraZeneca and J&J Vaccines. This journal club will discuss Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination and Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine.

This event will be led by Joyce Pak and Claire Su, both are PhD students in the Epidemiology Department.

Register

ACTIV-6: A Direct-to-Participant Platform Trial of Repurposed Drugs for COVID-19 in Non-hospitalized Patients

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Susanna Naggie, MD, MHS, of Duke Clinical Research Institute and Elizabeth Shenkman, PhD, of the University of Florida.

Presenters
Susanna Naggie, MD, MHS
Associate Professor of Medicine
Duke Clinical Research Institute

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Machine Learning Seminar Series: Recent Machine Learning Developments for Advancing Precision Medicine

In this session of the Machine Learning Seminar series, Michael Kosorok, PhD, will present on recent developments in Machine Learning and how these developments will impact and advance Precision Medicine. Precision medicine is "an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person." This approach will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people.

Presenter
Michael Kosorok, PhD
W.R. Kenan, Jr. Distinguished Professor, Department of Biostatistics
Professor, Department of Statistics and Operations

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