Orientation for New Clinical Research Personnel - Spring 2020 Series
Now available only as an ONLINE Webex Presentation.
To align with current UNC policy regarding the Covid-19 outbreak, we are transitioning the Orientation for New Clinical Research Personnel to a webex only event for all six weeks.
Handouts and slides for the presentation will be emailed to all registrants prior to the weekly courses. To receive an attendance certificate, post session evaluation must be completed, and an email sent to amanda_wood@med.unc.edu requesting a certificate.
This six 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 6 weekly modules, held on Tuesday Mornings from 9:30am to 12:00pm in Room 219 Brinkhous-Bullitt Building (TraCS Institute). Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered during each module include:
March 17, 2020 | 9:30 AM - 12 PM | Week 1
• Introduction to Orientation Series (Amanda Wood) - 9:30 am - 9:45 am
• NRP and Educational Programs for Research Personnel (Terry Hartman) - 9:45 am - 10:05 am
• Running a Clinical Trial from CDA to Study Closure / OCT Services and Resources (Christine Nelson) - 10:05 pm to 12:00pm
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March 24, 2020 | 9:30 AM- 12 PM | Week 2
• UNC Institutional Review Board Processes (IRB Analysts / Staff) - 9:30 am - 11:30 am
• Conflict of Interest (Joy Bryde) - 11:30 am - 12:00 pm
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March 31, 2020 | 9:30 AM- 12 PM | Week 3
• Good Clinical Practices and Study Documentation (Juanita Cuffee) - 9:30 am - 10:45am
• Informed Consent Process (Catherine Barnes) - 10:50 am - 11:45 am
• Budgeting for Clinical Research, Accounting of Funds (Jill Cunnup) - 11:45 am - 12:00 pm
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April 7, 2020 | 9:30 AM - 12 PM | Week 4
• Contracts and Clinical Trial Agreements (Vonzell Jones) - 9:30 am - 10:10 am
• Billing Coverage Analysis overview (Andrea Eiring ) - 10:10 am - 10:50 am
• Research Monitor Access (Catherine Barnes) - 10:55 am - 11:15 am
• Preparing and Executing NIH Grant Budgets (Sandy Barnhart) - 11:15 am - 12:00 pm
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April 14, 2020 | 9:30 AM - 12 PM | Week 5
• Study Start Up and Roles of Research Personnel (Laura Viera) - 9:30 am - 10:25 am
• Recruitment Services / Carolina Data Warehouse (Emily Olsson) - 10:30 am - 11:30 am
• Hospital Device Management Policy (Amanda Wood) - 11:30 am - 12:00pm
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April 21, 2020 | 9:30 AM - 12 PM | Week 6
• UNC Hospitals Investigational Drug Services (Andrew Thorne) - 9:30 am - 10:05am
• Investigator-Initiated Study Processes (Chris Nelson / Valorie Buchholz) - 10:05 am - 10:35 am
• ClinicalTrials.gov and ICMJE requirements (Monica Coudurier) - 10:40 am - 11:20 am
• Adverse Event Evaluation and Documentation (Marie Rape) - 11:20 am - 11:50 am
• IND and IDE Studies at UNC (Amanda Wood) - 11:50 am - 12:00 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)
