Orientation for New Clinical Research Personnel

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. Pre-requisites for attending this training are completion of the CITI Good Clinical Practice (GCP) and CITI Ethics online courses available at: www.citiprogram.org The orientation will be divided into 4 weekly modules of 2 hours each. Research personnel are encouraged to attend all 4 modules, but may choose to attend only those of particular interest or relevance.

When Sep 12, 2012 12:00 AM to
Oct 03, 2012 12:00 AM
Where Brinkhous-Bullitt, Room 219
Contact Name
Contact Phone 9198432883
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Sept 12, 2012: Week 1 module – Overview of Orientation and IRB

  • Introduction and overview of clinical research orientation
  • NCRP and educational programs for research personnel
  • IRB overview

Sept 19, 2012: 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

Sept 26, 2012: Week 3 module – Contracting and Hospital Administrative Elements

  • Conflict of interest
  • Contracts and clinical trial agreements
  • ClinicalTrials.gov and ICMJE requirements
  • Hospital device management policy & Investigational Drug Service

Oct 3, 2012: Week 4 module – Clinical Trial Management and Budgeting

  • Clinical Research Management System (CRMS) overview
  • Hospital accounting, budgeting for clinical research, accounting of research funds
  • Medicare coverage analysis


LINK TO REGISTER:  https://apps.research.unc.edu/events/index.cfm?event=events.eventDetails&event_key=C554E06A4F4AD7D8EBF8AF049D948C808ED2B91C


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