This five 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 5 weekly modules, held on Wednesdays from 1PM-3PM. Research personnel are encouraged to attend all 5 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered during each module include:

August 27, 2014 | 1 - 3 PM | 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

September 3, 2014 | 1 - 3 PM | 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 10, 2014 | 1 - 3 PM | Week 3 module: Contracting and Clinical Trial Administrative Elements

• HIPAA, Confidentiality and Privacy
• Contracts and clinical trial agreements
• ClinicalTrials.gov and ICMJE requirements
• Essential Documents

September 17, 2014 | 1 - 3 PM | Week 4 module: Conflict of Interest, Hospital Accounting and Budgeting

• Conflict of interest
• Recruitment support services
• Budgeting for clinical research, accounting of research funds
• Hospital device management policy (Claudia) & Investigational Drug Service
• Industry Sponsored Clinical Trial Development

September 24, 2014 | 1 - 3 PM | Week 5 module: New module tentative title How to conduct research at UNC-CDA to closure.

• Conducting research at UNC

For questions, please contact Claudia Christy, cgc@med.unc.edu, 919-843-9445

• Time:  1PM to 3PM.
• 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 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®. Weeks 1 and 2 have been approved for 2 Contact Hours and Weeks 3 and 4 have been approved for 1 Contact Hour. Certificates of attendance will be available at the conclusion of the training.