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UPCOMING LIVE SEMINARS
 
Clinical Project Management: Advanced
September 10-11, 2014
San Diego, CA






Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance August 2010

Course Description

Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).

VideoPreview

 

Learning Objectives

  • Discuss how QA differs from QC and who is responsible for each
  • Determine who gets audited and factors and metrics for assessing when or why to audit
  • Discuss guidelines on how the FDA trains its investigators to audit Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs)
  • Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs

Who Should Attend

  • Clinical Quality Assurance Auditors
  • Clinical Quality and Compliance Professionals
  • Clinical Research Associates (CRAs)
  • Project Managers
  • Medical Monitors
  • Regulatory Affairs Professionals
  • Clinical Research Coordinators (CRCs)
  • Clinical Investigators (PIs)
  • IRB Administrators and Members

Instructor 

Elizabeth Ronk Nelson, MPH

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Course Length Time

2 hours; 1:00 - 3:00 p.m. Eastern

Course Dates 

August 26, 2010                                       

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.