Training

Text:
Increase font size
Decrease font size

Course Descriptions

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

The orientation is 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. The topics to be covered during each module include:

Week 1 Module-Overview of Orientation and IRB Process

  • Introduction and overview of clinical research orientation
  • NCRP (Network of Clinical Research Professionals) and educational programs for research personnel
  • IRB Overview

Week 2 Module-Study Implementation and Good Clinical Practices (GCPs)

  • Study implementation and roles of research personnel
  • Good Clinical Practices (GCPs) and study documentation
  • Informed Consent Process

Week 3 Module-Contracting and Clinical Trial Administrative Elements

  • Conflict of Interest
  • Contracts and Clinical Trial Agreements (CTAs)
  • Trial Registry: ClinicalTrials.gov and ICMJE requirements
  • Hospital device management policy
  • Investigational Drug Services

Week 4 Module-Clinical Trial Management, Hospital Accounting, and Budgeting

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

Questions:

Please call the OCT at (919) 843-2698 with any questions.