Orientation for New Clinical Research Personnel

A five-part orientation series, Wednesdays, 1-3:30 PM, beginning August 27

When Aug 27, 2014
from 01:00 PM to 03:30 PM
Where Brinkhous-Bullitt Room 219
Contact Name
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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 here).

The orientation is divided into five weekly modules, held on Wednesdays. Research personnel are encouraged to attend all five 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 | 1-3:30 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 | 1-3:30 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 | 1-3:30 PM | Week 3 module: Contracting and Clinical Trial Administrative Elements

• Clinical Research Management System (CRMS)
• Contracts and clinical trial agreements
• ClinicalTrials.gov and ICMJE requirements
• Hospital accounting, routing charges, Epic
• Billing coverage analysis

September 17, 2014 | 1-3:30 PM | Week 4 module: Conflict of Interest, Hospital Accounting and Budgeting

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

September 24, 2014 | 1-3:30 PM | Week 5 module: Putting It All Together – From CDA to Study Closure

• Running a clinical trial, beginning to end
• Study start up process
• Conducting the actual study
• Study closure

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