| Event Title | Orientation for New Clinical Research Personnel - Spring Series |
| Location | Brinkhous-Bullitt 219 |
| Sponsor | NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH |
| Date/Time | 03/07/2018 - 04/04/2018 |
| Session Status | Session | Session Date | Start Time | End Time | Cutoff |
|---|---|---|---|---|---|
| Expired | Week 1: Orientation Series Overview, Education/NCRP and IRB Process | 03/07/2018 | 1:30 PM | 12:00 AM | none |
| Expired | Week 2:Study Start-up, Good Clinical Practices, Informed Consent | 03/14/2018 | 1:30 PM | 12:00 AM | none |
| Expired | Week 3: Contracting, Clinical Trial Registration, Hospital Drug & Device Policies, Recruitment Support Services | 03/21/2018 | 1:30 PM | 12:00 AM | none |
| Expired | Week 4: COI, Billing Coverage Analysis, and NIH & Industry Research Budgets | 03/28/2018 | 1:30 PM | 12:00 AM | none |
| Expired | Week 5: Essential Documents, Putting It All Together: From CDA to Study Closure | 04/04/2018 | 1:30 PM | 12:00 AM | none |
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:
March 7, 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 (Erika Hanami) - 1:45 pm - 2:05 pm
• Seminar on UNC Institutional Review Board processes (IRB Analysts / Staff) - 2:05 pm - 4 pm
March 14, 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 (Terry Hartman) - 2:20 pm - 3:15 pm
• Informed consent process (Marie Rape) - 3:15 pm - 4 pm
March 21, 2018 | 1:30 PM- 4 PM | Week 3: Contracting, Clinical Trial Registration, Hospital Drug & Device Policies, Recruitment Services
• Contracts and clinical trial agreements (Trey Fraune) - 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
March 28, 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
• Preparing and Executing NIH Grant Budgets (Sandy Barnhart) - 2:00 pm - 2:45 pm
• Budgeting for clinical research, accounting of funds (Jill Cunnup) - 2:50 pm - 3:20 pm
• Billing Coverage Analysis overview (Andrea Eiring) - 3:20 pm - 4:00 pm
April 4, 2018 | 1:30 PM - 4 PM | Week 5: Essential Documents, Putting It All Together: From CDA to Study Closure
• Essential Documents (Val Buchholz) - 1:30 pm - 2:10 pm
• Running a clinical trial, beginning to end: from CDA to study closure (Chris Nelson / Val Buchholz) - 2:10 pm - 3:45 pm
