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