Orientation for New Clinical Research Personnel

Week 2 module: Study Implementation and Good Clinical Practices

When May 14, 2014
from 10:00 AM to 12:00 PM
Where Brinkhous-Bullitt Room 219
Contact Name
Contact Phone (919) 843-9445
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This four 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 four weekly modules, held on Wednesdays. Research personnel are encouraged to attend all four modules, but may choose to attend only those of particular interest or relevance. The topics to be covered during each module include: 


 May 7, 2014 | 1 - 3 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


 May 14, 2014 | 10 AM - 12 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


May 21, 2014 | 1 - 3 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


May 28, 2014 | 10 AM - 12 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 


 CEUs: Each session has been pre-approved for Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®. Weeks 1 and 2 have been approved for 2 Contact Hours and Weeks 3 and 4 have been approved for 1 Contact Hour. Certificates of attendance will be available at the conclusion of the training.

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