EVENTSbyORISEvent management and registration system
Use this event registration system to register for upcoming conferences, classes, workshops, seminars, and other training activities sponsored by various departments and offices at UNC-Chapel Hill.
To begin your online registration, simply browse the event listings, select the event you wish to attend and complete the online registration form. Your registration will be confirmed by email.
To Inquire about becomming an Admin of your own events, contact Lori Saddler at lsaddler@unc.edu
NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
- Regulatory Service Group
Date/Time
04/26/2022
- 04/27/2022
For more information, contact the event administrator:
Hannah Kim
kim21h@live.unc.edu
Event Presenters
Name
Title
Marie Rape, RN,BSN,CCRC
Associate Director, TraCS Regulatory Program
Kim Brownley, PhD, CIP
Co-Director, TraCS Regulatory Service
Sorry, This event has expired
Session Status
Session
Session Date
Start Time
End Time
Cutoff
Expired
Clinical Protocol Development Series - Day 1
04/26/2022
9:00 AM
11:00 AM
none
Expired
Clinical Protocol Development Series - Day 2
04/27/2022
9:00 AM
11:00 AM
none
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 registration - 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
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.
