Orientation for New Clinical Research Personnel

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