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. The topics to be covered during each module include:
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
- Date: Wednesday, September 12, 2012
- Time: 1:00 PM - 3:00 PM
- Location: NC TraCS Institute, Brinkhous-Bullitt Building, Room 219, UNC-CH Campus
- Sponsor: NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
