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 registration
- UNC Scientific Review processes
- Protocol problems spots and ways to improve protocols
- Resources and tools available at UNC to support clinical protocol development

Audience: academic researchers, scientists, study coordinators, and students engaged in clinical research and/or clinical trials.

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

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

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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 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.

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What is the value of the p-value? A panel discussion on the controversy and proper use of the p-value in health research

The debate over the value and interpretation of p-value has endured since the time of its inception nearly 100 years ago. The use and interpretation of p-values vary by a host of factors, especially by discipline. These differences have proven to be a barrier when developing and implementing boundary crossing clinical and translational science. The purpose of this panel discussion is to discuss misconceptions, debates, and alternatives to the p-value.

This event is co-sponsored by UNC TraCS, Duke University and Wake Forest University CTSA Biostatistics, Epidemiology and Research Design (BERD) Cores.

Presenters:
Charles Poole, ScD (Associate Professor of Epidemiology, UNC)
Lucy D'Agostino, PhD (Assistant Professor of Statistics, Wake Forest University)
Charles Scales, MD, MSHS (Associate Professor of Surgery, Duke University)

Facilitator:
Marcella Boynton, PhD (Assistant Professor, General Internal Medicine, UNC/NC TraCS)

For any questions regarding this event, please contact Krista Lloyd at This email address is being protected from spambots. You need JavaScript enabled to view it..

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