Orientation for New Clinical Research Personnel

Week 3: Contracting and Clinical Trial Administrative Elements

When Jan 24, 2014
from 10:00 AM to 12:00 PM
Where Brinkhous-Bullitt Room 219
Contact Name
Contact Phone 919-966-6844
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This four part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The objectives are to introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. Attendees are encouraged to complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation (available online at: https://www.citiprogram.org/Default.asp)

The orientation is divided into 4 weekly modules, held on Fridays from 10am - 12pm. Research personnel are encouraged to attend all 4 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered during each module include: 

January 10, 2014: Week 1 module – Orientation Series Overview and IRB Process                                                

January 17, 2014: Week 2 module – Study Implementation and Good Clinical Practices

January 24, 2014: Week 3 module – Contracting and Clinical Trial Administrative Elements
•   Clinical Research Management System (CRMS)
•   Contracts and clinical trial agreements
•   ClinicalTrials.gov and ICMJE requirements
•   Hospital device management policy & Investigational Drug Service
•   Industry Sponsored Clinical Trial Development

January 31, 2014: Week 4 module – Conflict of Interest, Hospital Accounting and Budgeting

Sponsored by the NC Translational and Clinical Sciences Institute (NIH CTSA at UNC-CH), UNC Office of Clinical Trials, and the UNC Network of Clinical Research Professionals

More information about this event…