This workshop is recommended for all clinical research coordinators (CRCs), research assistants, or research administrators who are new to the research role or new to working at UNC. The course introduces the UNC offices involved in clinical trials, federal and local regulations governing conduct, and provides an overview of best practices utilized in the implementation of clinical research.
The orientation is divided into 6 weekly modules, held once in the Spring semester and once in the Fall semester, on Wednesday afternoons from 1:30pm to 4:00pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance.
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.
Topics covered:
Review human subject research protection and the IRB
Discuss research compliance and required approvals at UNC
Review use of the Clinical Research Management System (CRMS)
Review basic elements of contract negotiation and grant management
Define appropriate responsibilities for study team members
Describe steps for successful implementation of a study
Describe appropriate management of study documentation
Define Good Clinical Practices (GCP)
Review the informed consent process
Pre-requisites are completion of the CITI Good Clinical Practice (GCP) and CITI Ethics online courses available at: www.citiprogram.org.
Budgeting for Clinical Research, Accounting of Funds (Jill Cunnup)
Preparing and Executing NIH Grant Budgets (Sandy Barnhart)
Week 5
Study Startup and Roles of Research Personnel, Recruitment Services and CDW, UNC Hospitals Investigational Drug Services, Investigational Device Management Policy
Study Start Up and Roles of Research Personnel (Laura Viera)
Recruitment Services / Carolina Data Warehouse (Emily Olsson)
UNC Hospitals Investigational Drug Services (Andrew Thorne)
Hospital Device Management Policy (Amanda Wood)
Week 6
Investigator-Initiated Study Processes, ClinicalTrials.gov and ICMJE requirements, Adverse Event Evaluation and Documentation, and Investigational Drug and Device studies at UNC
