Writing Unit-level and Study-Level Clinical Research SOPs

Join the UNC Network for Research Professionals (NRP) for an education session on writing clinical research SOPs.

1. Define the purpose and core functions of SOPs within the UNC research context
2. Differentiate SOP levels, responsibilities, and when to develop unit vs. study-level SOPs
3. Identify key structural elements, formatting standards, and when to include Work Instructions
4. Apply best practices for writing, managing, and maintaining SOPs
5. Recognize common SOP topics, pitfalls, and available resources
6. Understand AI’s role, responsibilities, and practical applications in SOP development
7. Learn from unit-level experiences and real-world examples

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Following the presentation, participants will take part in an interactive workshop where they can bring their own study recruitment materials, plans or questions, receive real-time feedback, and immerse themselves in the path of their choosing. Participants will choose one of the breakout rooms listed below and receive more in-depth and customized knowledge of topics covered in prior sessions of the series.

For the Workshop, participants will choose to:
- Troubleshoot existing recruitment plan in a group break-out session with your peers and the facilitator.
- Redesign or refine one recruitment material using audience-centered design strategies and AI-assisted tools, with real-time feedback from peers and the facilitator.
- Practice applying AI to translate complex study information into clear, participant-friendly language with facilitator guidance.

Please note: Attending Recruitment 101 in the series is strongly preferred.

Presenters:
Summer Choudhury, MPH
Program Manager, Recruitment & Retention Program
NC TraCS Institute

Ali Sora, MS
Research Project Manager, Recruitment & Retention Program
NC TraCS Institute

Edmund P. Fernandez, MA
Data Systems & Assessment Specialist, Writing Skills Development Program
SOM Dept. of Health Sciences

Sarah Sutter, MPH
Research Project Manager, Recruitment & Retention Program
NC TraCS Institute

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Reproducibility Rounds: How Reproducible is Health Science Research?

We will discuss the methods, results, and implications of a series of scoping and systematic reviews that synthesized evidence on the reproducibility of health science research. Specific aims of the projects included describing and categorizing methods and metrics used to quantify reproducibility, synthesizing estimates of the prevalence of reproducible research, and characterizing factors associated with reproducibility. We will describe our dataset of 1,340 articles with a focus on the sub-set with empirical data. We will report on the seven methods used for conducting reproducibility research, 38 metrics to quantify reproducibility, 180 estimates of the prevalence of reproducibility, and 234 factors associated with reproducibility which we grouped into modifiable and non-modifiable categories. Finally, we will discuss the significant heterogeneity in the evidence and challenges in synthesizing this data.

Speakers:
Niklas Bobrovitz, MD, MSc, DPhil
third-year emergency medicine resident
Centre for Health Informatics
University of Calgary

Stephana Moss, MSc, PhD
Assistant Professor
Department of Pediatrics
Dalhousie University

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There and Back Again: A Geospatial SHIRE Journey

This seminar will discuss geospatial analysis within the Secure Health Informatics Research Environment (SHIRE). Attendees will learn how to bring geospatial data there, analyze and manipulate it within the SHIRE, and bring one's precious geospatial research results back again. No trolls were turned to stone in the making of this presentation.

Speaker:
Tomas J. McIntee, PhD
Research Data Scientist
TraCS Data Science Lab

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Seminars in the NC TraCS Data Science Lab Seminar Series cover a range of topics related to health care data science, clinical data, data engineering, and working in these areas at UNC-Chapel Hill. These hybrid seminars are usually held monthly on the third Tuesday of each month from 12:30-1:30 p.m. in the NC TraCS suite on the 2nd floor of Brinkhous-Bullitt or via Zoom.

Accelerate your ideas through customer discovery and market opportunity validation!

KickStart Venture Services is recruiting community startups as well as faculty, post-doctoral fellows, graduate students, and undergraduate students with innovations and an interest in commercialization to participate in their virtual NSF I-Corps program. They will teach you the principles of customer discovery to help you better understand the market potential of your innovation!

The National Science Foundation’s Innovation Corps Program (I-Corps) was launched in 2011 and has quickly become one of the world’s largest and most successful technology commercialization accelerators. The I-Corps regional program helps researchers and aspiring innovators determine if they are solving a real-world problem with true market opportunity. NSF’s I-Corps Program not only provides funding, mentoring, and networking opportunities to help commercialize promising technologies, it is offered at NO COST to the community.

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For more information about the I-Corps Program, visit KickStart Venture Services.