Co-Director, TraCS Regulatory Program; Research Associate Professor, Department of Psychiatry
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Clinical Protocol Development Series - Day 1
Clinical Protocol Development Series - Day 2
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
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
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