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CLINICAL RESEARCH TRAINING

HUMAN SUBJECTS PROTECTION COURSE

COURSE DESCRIPTION:

 
Objectives:
 
Learners will understand how to prepare for and host an FDA inspection, comprehend potential inspection outcomes for investigators, describe key topics assessed in the FDA’s BIMO Guidelines for Site inspections and connect these with examples of evidence the FDA will review, and understand the guideline as a foundation for quality assurance activities.

The approximate time to complete each session and quiz is noted next to each topic.

Upon successful completion of this course, learners will be eligible to receive 2 continuing education contact hours.

COURSES

FDA Inspections 101 - (55 minutes)
FDA Inspections 102 - (55 minutes)

Training Solutions For These Roles

This course provides learners with information about why, when, and how FDA inspections of clinical investigation sites and sponsors occur

TYPE

Online – Train on Your Own Time


CEUs

2 hours (.2 CEUs)

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