NC TraCS Institute Clinical Protocol Development Series (virtual)

This two-day online series is designed to provide researchers with knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study.

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
Sponsored by NC TraCS Institute.