Clinical Protocol Development Workshop -
February 1st and 2nd, from 2:00pm to 4:00pm
The goal of this two day online workshop 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 2:00pm, and a question-and-answer session will follow each presentation.
The first day of the workshop will provide an introduction and focus on the following key points:
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Who needs a clinical protocol and why it is important
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Types of clinical protocols, and content expectations for sections of the protocol
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Introduction to clincaltrials.gov
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UNC Scientific Review processes
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Protocol problems spots and ways to improve protocols
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Resources and tools available at UNC to support clinical protocol development
On the second day of the workshop, we will take a "deeper dive" into clinical study design, statistics, and their impact on clinicaltrials.gov reporting:
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Clinical Protocol Study Design - aims, objectives, endpoints, and outcomes
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Statistical Analysis, sample size considerations, data management
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Clinicaltrials.gov - outcome measure reporting
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Protocol problem spots and ways to improve protocols
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 application for maintenance of ACRP's ccrc®, ccra® or cpi®, certification designations will be available for attendees
