Orientation for New Clinical Research Personnel

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. Pre-requisites for attending this training are completion of the CITI Good Clinical Practice (GCP) and CITI Ethics online courses available at: www.citiprogram.org/Default.asp

When Nov 07, 2012 12:00 AM to
Dec 05, 2012 12:00 AM
Where Brinkhous-Bullitt, Room 219
Contact Name
Contact Phone 9198432883
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Location for ALL modules: Brinkhous-Bullitt, Room 219
Time: 2:00 PM-4:00 PM

The orientation will be divided into 4 weekly modules of 2 hours each. Research personnel are encouraged to attend all 4 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered during each module include:

Nov 7, 2012: Week 1 module – Overview of Orientation and IRB
-Introduction and overview of clinical research orientation 
-NCRP and educational programs for research personnel 
-IRB overview

Nov 14, 2012: 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

Dec 5, 2012: Week 3 module – Contracting and Hospital Administrative Elements
-Conflict of interest 
-Contracts and clinical trial agreements 
-ClinicalTrials.gov and ICMJE requirements 
Hospital device management policy & Investigational Drug Service

Dec 12, 2012: Week 4 module – Clinical Trial Management and Budgeting
-Clinical Research Management System (CRMS) overview 
-Hospital accounting, budgeting for clinical research, accounting of research funds 
-Medicare coverage analysis

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