Presentation Objectives:

Jaime Kauwell, Clinical Trial Quality Assurance Program Coordinator, will present on common audit findings, when and how to develop an action plan or CAPA, and discuss research billing compliance. 

Objectives:

·         Identify common findings found in research study reviews conducted by the CTQA Program in accordance with federal, state, ICH GCP and institutional regulations

·         Understand what findings require an action plan vs. a corrective and preventative action (CAPA) plan

·         Explain what is needed to create an effective CAPA

·         Highlight key billing compliance topics and how to avoid major errors

 Attendance at this event has been pre-approved for 1 contact hours of clinical research education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certification designations