Orientation for New Clinical Research Personnel - Fall 2018 Series
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 in Room 219 Brinkhous-Bullitt Building (TraCS Institute). 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:
September 12, 2018 | 1:30 PM - 4 PM | Week 1: Orientation Series Overview, Education/NCRP and IRB Process
• Introduction to Orientation series (Marie Rape) - 1:30 pm - 1:45 pm
• NCRP and educational programs for research personnel (Terry Hartman) - 1:45 pm - 2:05 pm
• Seminar on UNC Institutional Review Board processes (IRB Analysts / Staff) - 2:05 pm - 4 pm
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September 19, 2018 | 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 (Marie Rape) - 3:15 pm - 4 pm
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September 26, 2018 | 1:30 PM- 4 PM | Week 3: Contracting, Clinical Trial Registration, Hospital Drug & Device Policies, Recruitment Services
• Contracts and clinical trial agreements (Dana Gatz) - 1:30 pm - 2:10 pm
• ClinicalTrials.gov and ICMJE requirements (Monica Coudurier) - 2:10 pm - 2:40 pm
• UNC Hospitals Investigational Drug Service (Sue Pope) - 2:45 pm - 3:10 pm
• Hospital device management policy (Amanda Wood) - 3:10 pm - 3:20 pm
• Recruitment Services (Carol Breland) - 3:20 pm - 4 pm
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October 3, 2018 | 1:30 PM - 4 PM | Week 4: Conflict of Interest, Billing Coverage Analysis, and NIH & Industry Research Budgets
• Conflict of Interest (Joy Bryde) - 1:30 pm - 2:00 pm
• Billing Coverage Analysis Overview (Andrea Eiring) - 2:00 pm - 2:40 pm
• Budgeting for clinical research, accounting of funds (Jill Cunnup) - 2:45 pm - 3:15 pm
• Preparing and Executing NIH Grant Budgets (Sandy Barnhart) - 3:15 pm - 4:00 pm
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October 10, 2018 | 1:30 PM - 4 PM | Week 5: Essential Documents, Putting It All Together: From CDA to Study Closure
• Running a clinical trial, beginning to end: from CDA to study closure (Chris Nelson) - 1:30 pm - 3:00 pm
• Essential Documents (Val Buchholz) - 3:05 pm - 3:45 pm
• Research Monitor Epic Access (Maria Strubbe) - 3:45 pm - 4:00 pm
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Sponsored By NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
Location: Brinkhous-Bullitt 219
Administrator: amanda_wood@med.unc.edu
Sponsor: NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
For questions, please contact Amanda Wood, amanda_wood@med.unc.edu , 919-843-9445
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.
This workshop series is sponsored by NC Translational and Clinical Sciences Institute (NIH CTSA at UNC-CH), UNC Office of Clinical Trials, and the UNC Network of Research Professionals (NRP)
