Orientation for New Clinical Research Personnel – January 2014

This four part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research.

When Jan 31, 2014 from 10:00 AM to 12:00 PM (US/Eastern / UTC-500)

This event is part of a recurring Event. Go to the original Event.

Where Brinkhous-Bullitt Building, Room 219, UNC-CH Campus
Contact Name
Contact Phone 919-966-6844
Web Visit external website
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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                                                

  • Introduction and overview of orientation series
  • NCRP and educational programs for research personnel
  • UNC Institutional Review Board process

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

  • Study implementation and roles of research personnel
  • Good Clinical Practices and study documentation
  • Informed consent process
  • Recruitment support services

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

  • Conflict of interest
  • Hospital accounting, routing charges, Epic
  • Billing coverage analysis
  • Budgeting for clinical research, accounting of research funds

For questions, please contact Marie Rape, marie_rape@med.unc.edu, 919-966-6844