Event Details
Orientation for New Clinical Research Personnel Return to listing

  Description

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

  • Time: 10:00 AM - 12:00 PM
  • Location: Brinkhous-Bullitt Building, Room 219, UNC-CH Campus
  • Sponsor: NC Translational and Clinical Sciences Institute (NIH CTSA at UNC-CH), UNC Office of Clinical Trials, and the UNC Network of Clinical Research Professionals
  • CEUs: Each session has been pre-approved for 2 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®. Certificates of attendance will be available at the conclusion of the training.
  Location: Brinkhous-Bullitt Building, Room 219, UNC-CH Campus
  Date: 01/10/14 - 01/31/14   (Varies depending on session chosen)
  Time: (See session details)
  Sponsor: NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
  Price: N/A
     
  For more information, contact the event administrator: Marie Rape mzeldin@med.unc.edu

Session Date Time Additional Fees
Week 1 module -Orientation Series Overview and IRB Process 01/10/2014 10:00 AM - 12:00 PM $ 0.00
Week 2 module - Study Implementation and Good Clinical Practices 01/17/2014 10:00 AM - 12:00 PM $ 0.00
Week 3 module -Contracting and Clinical Trial Administrative Elements 01/24/2014 10:00 AM - 12:00 PM $ 0.00
Week 4 module - Conflict of Interest, Hospital Accounting and Budgeting 01/31/2014 10:00 AM - 12:00 PM $ 0.00

THIS EVENT HAS EXPIRED
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