Clinical Protocol Development Series

The goal of this two day series is to provide researchers with knowledge, tools and resources to aid in the development of a scientific protocol for a clinical research study. Both sessions will begin at 9:00 AM and a question-and-answer session will follow each presentation.

The first day of the series will provide an introduction and focus on the following key points:
- Who needs a clinical protocol and why it is important
- Types of clinical protocols, and content expectations for sections of the protocol
- Introduction to clincaltrials.gov
- UNC Scientific Review processes
- Protocol problems spots and ways to improve protocols
- Resources and tools available at UNC to support clinical protocol development 

ACRP Contact Hours: 4.0 Contact Hours of clinical research education on application for maintenance of ACRP's ccrc®, ccra® or cpi®, certification designations will be available for attendees

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If you have any questions, please contact Marie Rape at This email address is being protected from spambots. You need JavaScript enabled to view it..

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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During this webinar, leaders of the STAR Network will discuss how STAR can support multi-site clinical data driven research. The STAR Clinical Research Network is part of a national network funded by PCORI to support patient-centered research. The STAR network engages a diverse array of hospitals, clinics and health systems across Vanderbilt, the Vanderbilt Health Affiliated Network, Wake Forrest, Duke, UNC, Health Sciences South Carolina, and Mayo Clinic, with electronic health records on over 14 million patients. For more information about the STAR CRN Network visit: https://starcrn.org

Speakers: 
Russell Rothman, MD, Network Principal Investigator, Vanderbilt University Medical Center - "Update on STAR Clinical Research Network."
Rowena Dolor, MD, Internal Medicine, Duke Clinical Research Institute Great City - "Investigator Perspectives on the STAR - CRN."
Stacie Dusetzina, PhD, Department of Health Policy, Vanderbilt University School of Medicine - "Primary Nonadherence to Specialty Drugs Among Medicare Beneficiaries."

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Clinical Protocol Development Series

The goal of this two day series is to provide researchers with knowledge, tools and resources to aid in the development of a scientific protocol for a clinical research study. Both sessions will begin at 9:00 AM and a question-and-answer session will follow each presentation.

On the second day of the series we will take a "deeper dive" into clinical study design, statistics, and their impact on clinicaltrials.gov reporting:
- Clinical Protocol Study Design
- aims, objectives, endpoints, and outcomes
- Statistical Analysis, sample size considerations, data management
- Clinicaltrials.gov
- outcome measure reporting
- Protocol problem spots and ways to improve protocols

ACRP Contact Hours: 4.0 Contact Hours of clinical research education on application for maintenance of ACRP's ccrc®, ccra® or cpi®, certification designations will be available for attendees

Register

If you have any questions, please contact Marie Rape at This email address is being protected from spambots. You need JavaScript enabled to view it..

Real World Evidence in the COVID Era: A New Treatment Option

Join the NC TraCS Comparative Effectiveness Research team and guest expert Timothy Sheahan, PhD, to discuss the phase 2 trial results of molnupiravir, the new potential treatment for COVID-19.

Journal article for this discussion: Molnupiravir, an Oral Antiviral Treatment for COVID-19 - https://www.medrxiv.org/content/10.1101/2021.06.17.21258639v1

Discussion Leaders

Michele Jonsson-Funk, PhD, Associate Professor
Epidemiology, Gillings School of Global Public Health

Timothy Sheahan, PhD Assistant Professor
Epidemiology, Gillings School of Public Health

Sara Dejene, PhD Candidate
Epidemiology, Gillings School of Global Public Health

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This is a two-part course in phlebotomy for research brought to you by the NC TraCS RCMU and CTRC. The goal of the course is to provide the necessary education and experience clinical research staff may need to complete blood draws for clinical research protocols. The course will consist of lecture, an exam, and hands-on learning. To successfully complete the course you must attend both sessions, pass the exam, and successfully complete three supervised blood draws.

Please note that practice blood draws will be performed on members of the class and all attendees should be prepared and willing to have practice draws performed on themselves. Completion of this course does not result in phlebotomy certification.  Attendees who successfully complete the course will be provided with a certificate of completion to document research phlebotomy training.

Cost:  $115  - Payment method accepted: UNC account funds only (chartfield string)

Sessions: 
Session 1- Friday, October 29th, 09:00am - 2:30pm
Session 2- Friday, November 5th, 11:00am - 3:00pm

Location for both sessions:  NC TraCS, 2nd Floor Brinkhous-Bullitt, Conference Room 219 (note: hands on training will be completed in the afternoon of Day 2 in the CTRC, 1st Floor Burnett-Womack)

Late arrival and No-show Policy - due to the condensed nature of the class we cannot make up missed material resulting from arriving late for class. Therefore, once the class begins there will be a strict no-admittance policy.

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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. 

Registration is open for the 2021-2022 TraCS Professional Development Seminar series. This seminar series is aimed at research professionals, graduate students, postdocs and early stage faculty researchers. In this series, we cover foundational skills useful for career development in clinical/translational research.

The TraCS Professional Development Seminar series is split into 4 modules: Finding Funding, Communication Skills, Mentor-Mentee Training, and Rigor and Reproducibility.

Communication Skills

Through the UNC Event Registration system, you will be able to select which sessions you would like to attend. Please note: the Zoom link that you receive upon registration will work for all sessions within the Communication Skills module. Each session will be held in-person and/or via Zoom on Fridays.

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Embedding Pragmatic Trials into Emergency and Critical Care. 

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features: Matthew W. Semler and Jonathan D. Casey MD, MSc, Assistant Professor, Vanderbilt University Medical Center.

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