The goal of the training is to provide an introduction to the job function of the Clinical Research Auditor. The course is structured for individuals seeking to learn more about GCP auditing, including site and sponsor/CRO audits, as well as vendor audits.
Describe and discuss FDA regulations and Good Clinical Practice
Explains roles and responsibilities of a Clinical Research Auditor
Describes types of audits, and the responsibilities of the auditor in preparation, activities, and follow-up
Examine and apply the FDA’s methods for inspection of Clinical Investigators, and Sponsor/CROs
Discuss Inspectional Findings, regulatory compliance, quality issues and documentation
AGENDA: 8:30 am - 4:30 pm
Good Clinical Practice and U.S. FDA Regulations Refresher
FDA BIMO Inspections and Guidances
FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions
Auditing Overview
Audit Preparation: Developing the Audit Plan and Preparing for the Audit
Conducting Audits
Investigative Sites
Sponsor/CRO
Clinical Vendor Assessments
Spot Checking: Sampling Documents and Data For Trend Analysis
Audit Report Writing and Post Audit Documentation
Communicating Findings with Auditees and Clients
TYPE
KNOWLEDGE LEVELS:
WHAT’S INCLUDED
Clinical Quality and Compliance Professionals
New and Aspiring Auditors
Clinical Research Associates and Project Managers
