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

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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..

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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Join NC TraCS and the SOM CRSO for a presentation for current and future Principal Investigators on prioritizing diversity, equity, and inclusion (DEI) in research studies. Incorporating DEI principles is important throughout the research process – not just for recruitment. Learn practical methods for meaningfully integrating inclusivity into your own research practice.

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