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
Announcing Orientation for New Clinical Research Personnel – September 2013
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 1:00 – 3:00 PM. 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 – 3:00 PM
Location: Brinkhous-Bullitt Building, Room 219, UNC-CH Campus
Sponsors: 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
CLICK HERE TO REGISTER: tracs.unc.edu/CRC_Orientation2013
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., 919-966-6844