Event Details
Event Title NRP June Education Session: Regulatory Readiness for Sponsor-Investigators
Location Via Zoom
Sponsor UNC Network for Research Professionals
Date/Time 06/20/2024 12:00 PM - 1:00 PM
For more information, contact the event administrator: Sandy Barnhart sandy_barnhart@med.unc.edu
Event Presenters
Name Title  
Jamie Kauwell, MHA, CCRC, CHRC Director CTQA
Rachel Munoz, MS CTQA Auditor
Julie Uehling, MS, CCRP CTQA Auditor
Mary Raynor, BSN, ALNC, ACRP-CP CTQA Auditor
Bree Williams CTQA Auditor
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Our speakers will be the Clinical Trials Quality Assurance (CTQA) Director and Auditors, from the OVCR Clinical Research Compliance Office

Title: Regulatory Readiness for Sponsor-Investigators

Objectives:

1) Organize and Maintain Trial Master Files (TMF) and Investigator Site Files
2) Sponsor-Investigators (SI) differentiate between: FDA regulated trials and non-regulated trials
3) Identify responsibilities for SIs: Single site and Multi-site trials