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. EDT 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 & outcome measure reporting
- Protocol problem spots and ways to improve protocols
Day 1 presenters: Kim Brownley, PhD, CIP; Tammy Biondi, MS, PMP, CCRP; and Joyce M. Lanier, RRT, MSRC, CCRC
Day 2 presenters: Kim Brownley, PhD, CIP, and Monica Coudurier, BA
Audience: academic researchers, scientists, study coordinators, and students engaged in clinical research and/or clinical trials.
ACRP Contact Hours: 4.0 Contact Hours (2 hrs per session) of clinical research education on the application for the maintenance of ACRP's ccrc®, ccra® or cpi®, certification designations will be available for attendees
