This course will present the conceptual underpinnings of treatment effect estimation under random assignment and complement those underpinnings with a discussion of frequently encountered challenges in the context of social experimentation. Design, sampling, and analysis issues under random assignment will be addressed followed by a brief introduction to propensity score methods as a quasi-experimental option when random assignment is not feasible.

The event will be led by Kirsten Kainz, PhD. Much of Kainz’s work focuses on identifying impacts of education interventions as well as understanding the systemic nature of intervention in education and human services.

Presenter
Kirsten Kainz, PhD, Research Fellow
Frank Porter Graham Child Development Institute

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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

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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.

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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.

Adopting a Population Health Strategy to Aggressively Reduce Cardiovascular Risk: It Works in Rural Communities Too!

Sam Cykert, MD will describe how implementation of the Heart Health Now study affected cardiovascular risk when applied to high-risk patients in 219 practices across North Carolina. Half of these practices were in rural areas and a quarter of high-risk patients were Black. The discussion will focus on how lessons learned could systematically be applied in the context of practice support through "Primary Care Extension Centers."

The Inclusive Science Program (ISP) focuses on increasing the inclusion of populations that have been historically underrepresented in clinical and translational research. The ISP Spring Seminar Series highlights research with a focus on diverse representation.

Presenter
Sam Cykert, MD, Professor
UNC School of Medicine

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Learn more about the quality improvement activities happening at UNC as medical students and faculty mentors present their QI projects. Join for the whole symposium, or for a part of the event.

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Please join the HERO-TOGETHER team for a special HERO Town Hall. Robert Califf, MD will join HERO PIs Adrian Hernandez, MD and Emily O'Brien, PhD for an overview of the HERO program, importance of HERO-TOGETHER for understanding vaccine safety, and to share early findings. This Town Hall is open to anyone affiliated with a healthcare setting.

Learn more about the project or join the HERO registry to participate in the HERO-TOGETHER study at Heroes Research. For questions, please contactThis email address is being protected from spambots. You need JavaScript enabled to view it..

Registration is not required; WebEx information is below. Please mark your calendars.

Call in: 1-650-479-3207

Access Code: 120 884 3641

Password: 1234

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Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator Investigational New Drugs (INDs)

The Duke University School of Medicine Office of Regulatory Affairs and Quality is conducting an IND Workshop co-sponsored by the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD).

This workshop will:

• Define an investigational drug, including off-label use of FDA approved drugs
• Provide guidance on determining when the IND regulations apply to research studies
• Discuss the preparation and submission of IND applications to FDA
• Review maintenance and safety reporting requirements
• Review case scenarios

Presenters

Rachel Johnson, PhD, RAC, Regulatory Affairs Scientist, Duke University School of Medicine
Katherine Deland, PhD, Regulatory Affairs Scientist, Duke University School of Medicine

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NC TraCS Regulatory Support is available to provide guidance and assistance with IND and IDE submissions and understanding the regulatory requirements for Federally-regulated studies. UNC Investigators and study teams with questions about regulatory submissions and pathways can submit a request to speak with an expert.

See also: IDE workshop Mar 12

The TraCS Professional Development Seminar series is intended for research professionals, graduate students, postdocs and early stage faculty researchers. It covers foundational skills useful for career development in clinical/translational research.

The third module of this series is titled Mentor-Mentee Training. Developing and strengthening the mentor-mentee relationship is key to the education and training of future generations of research personnel.

Each session of the seminar will meet Fridays at 12:00 pm. This session is titled: Fostering Inclusion.

Presenter
Susan Pusek, DRSc, Director, Education Programs
NC TraCS Institute

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Are you interested in improving how you communicate your science? Janet Iwasa will present her work on science animation, graphics, and tools in this seminar.

This event is co-sponsored by the UNC Science Policy Advocacy Group and the UNC Science Writing and Communication Club as part of their 2021 Spring Communication Series.

Presenter
Janet Iwasa, PhD, Assistant Professor of Biochemistry
University of Utah

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Data and Safety Monitoring Boards for Trials of COVID-19 Treatments and Vaccines: The Challenges

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Susan S. Ellenberg, PhD. Ellenberg is a Professor of Biostatistics, Medical Ethics, and Health Policy at the University of Pennsylvania.

Presenter
Susan S. Ellenberg, PhD, Professor of Biostatistics, Medical Ethics, and Health Policy
University of Pennsylvania

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