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. Pre-requisites to attend these trainings are completion of the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules available online at: https://www.citiprogram.org/Default.asp

The orientation is divided into 4 weekly modules, held on Wednesdays from 1-3pm. 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:

September 4, 2013: Week 1 module – Overview of Orientation and IRB Process                                             

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

September 11, 2013: 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

September 18, 2013: Week 3 module –Contracting and Clinical Trial Administrative Elements

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

September 25, 2013: Week 4 module – Clinical Trial Management, Hospital Accounting and Budgeting

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

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

  • Time: 1:00 PM - 3:00 PM
  • Location: Brinkhous-Bullitt Building, Room 219, UNC-CH Campus
  • Sponsor: NC TraCS (Translational and Clinical Sciences) Institute (NIH CTSA at UNC-CH), UNC Office of Clinical Trials, and the UNC Network of Clinical Research Professionals

The New Coordinator Orientation modules have each been pre-approved for 2 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®, at no cost. Certificates of attendance will be available at the conclusion of the training.

  Location: Brinkhous-Bullitt Building, Room 219, UNC-CH Campus
  Date: 09/04/13 - 09/25/13   (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 - Overview of Orientation and IRB Process 09/04/2013 1:00 PM - 3:00 PM $ 0.00
Week 2 module - Study Implementation and Good Clinical Practices 09/11/2013 1:00 PM - 3:00 PM $ 0.00
Week 3 module -Contracting and Clinical Trial Administrative Elements 09/18/2013 1:00 PM - 3:00 PM $ 0.00
Week 4 module - Clinical Trial Management, Hospital Accounting and Budgeting 09/25/2013 1:00 PM - 3:00 PM $ 0.00

THIS EVENT HAS EXPIRED
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