Clinical Protocol Development Workshop

TraCS Regulatory invites academic researchers, scientists, study coordinators, and students engaged in clinical research/clinical trials to the Clinical Protocol Development Workshop. This two-day workshop will provide attendees with knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. There will be time for questions at the end of each presentation.

The first day of the workshop 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 workshop, 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