Content
10 modules
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 Advarra Completion Certificate
1.
Overview of the FDA's Bioresearch Monitoring Program
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2.
Clinical Investigators and the FDA's Authority to Inspect Them
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3.
Inspection Types and Assignments
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4.
Notification of Inspection and Preparation
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5.
The Focus of the Inspection
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6.
Inspection Process
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7.
Best Practices for a Clinical Investigator During the Inspection
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8.
Post Inspection Activities: Clinical Investigator
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9.
Post Inspection Activities: FDA
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10.
Knowledge Assessment
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