The goal of this two-day series is to provide researchers with the 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 a.m. ET 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
- UNC Scientific Review Committee processes
- Types of clinical protocols, and content expectations for sections of the protocol
- 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 - registration and outcome measure reporting
- Protocol problem spots and ways to improve protocols
Target Audience: academic researchers, scientists, study coordinators, and students engaged in clinical research and/or clinical trials.
ACRP Contact Hours Update: The ACRP no longer approves 3rd party requests for CE credit. However, attendees are still welcome to self-report to ACRP for CE credit.
