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 1:30 pm – 4 pm. 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:

Orientation for New Clinical Research Personnel  (Wednesdays) March / April 2017

 March 8, 2017 | 1:30 PM – 4 PM | Week 1: Orientation Series Overview, Education/NCRP and IRB Process

• Introduction and overview of orientation series (Marie Rape) – 1:30 pm – 1:45 pm
  • NCRP and educational programs for research personnel (Juanita Cuffee) – 1:45 pm – 2:05 pm 
  • UNC Institutional Review Board process (Charlotte Coley) – 2:05 pm – 4 pm (includes break)

March 15, 2017 | 1:30 PM– 4 PM | Week 2: Study Start-up, Good Clinical Practices, and Informed Consent

• Study start up and roles of research personnel (Laura Tuttle) – 1:30 pm – 2:15 pm 
  • Good Clinical Practices and study documentation (Juanita Cuffee) - 2:20 pm – 3:15 pm
  • Informed consent process, HIPAA (Marie Rape) – 3:15 pm – 4 pm

March 22, 2017 | 1:30 PM– 4 PM | Week 3: Contracting, Clinical Trial Administration (CT.gov, BCA), Essential Documents

• Contracts and clinical trial agreements (Nina Cannon) – 1:30 pm – 2:10 pm
  • ClinicalTrials.gov and ICMJE requirements (Monica Coudurier) – 2:10 pm – 2:40 pm 
  • Billing Coverage Analysis overview (Andrea Eiring) – 2:45 pm – 3:20 pm
• Essential Documents (Val Buchholz) – 3:20 pm – 4 pm

April 5, 2017 | 1:30 PM – 4 PM | Week 4: Recruitment, NIH & Industry Research Budgets, Hospital Drug & Device Policies

• Recruitment support services (Carol Breland) – 1:30 pm – 2:00 pm
• Budgeting for clinical research, accounting of funds (Jill Cunnup) - 2:00 pm – 2:35 pm
• Preparing and Executing NIH Grant Budgets (Sandy Barnhart) – 2:40 pm - 3:25 pm (includes break)
  • Investigational Drug Service (Sue Pope) – 3:25 pm – 3:55 pm
• Hospital device management policy (Marie Rape) – 3:55 pm – 4:00 pm

April 12, 2017 | 1:30 PM – 4 PM | Week 5: Conflict of Interest, Putting It All Together: From CDA to Study Closure

• Conflict of interest (Joy Bryde) – 1:30 pm – 2:10 pm
• Running a clinical trial, beginning to end: includes managing study start-up, conducting study, and study closure (Chris Nelson / Val Buchholz) – 2:10 pm – 3:45 pm

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

• Time:  1:30 pm to 4 pm
• 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 2.5 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®. Certificates of attendance will be available at the conclusion of the training.