RRT 330: FDA Clinical Investigator Inspections

Content
1 module

Rating

Course Length
15 mins

Instructor
Advarra University

Price
$95.00

Description

The US Food and Drug Administration (FDA) has a comprehensive program of on-site inspections and data audits to monitor the conduct of reporting of FDA-regulated research. The aims of these programs are to provide uniform guidance and specific instructions for conducting clinical investigator inspections and to gather evidence to support the regulatory decision-making process. This course is designed to help clinical investigators understand the goals of the inspections, prepare for them, and how to conduct any post-inspection follow-up. 

Objectives

  • Understand the history and importance of the Bioresearch Monitoring Program
  • Understand the difference between routine and for cause inspections
  • Discover best practices for preparing for an inspection, participating in an inspection, and following up after the inspection. 

Certificate

By completing/passing this course, you will attain the certificate (No Expiration) Advarra Completion Certificate

1.
RRT 330 FDA Clinical Investigator Inspections
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