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Section 2: Preparation for a Good Clinical Practice Inspection and FDA Audit

Description: This section outlines for you the preparation necessary to get ready for an FDA audit or a GCP inspection. It will give you useful tips that will give you confidence when the inspectors arrive at your site. Please click on the tabs to your right to go through the course in sequential order from the top to bottom tabs. Please begin your course by clicking the top tab to the right now! Good luck and enjoy this module! If you have any questions regarding the course please email us at info@clincoach.com or our lead trainer Paula Jones-Wright at pjwright@clincoach.com. You may also call us at any time at 902-463-9846.


   
  Clinical Research College Courses  
The courses are divided into sections. To complete an entire course you must finish all sections and pass the section quizzes. Once completed you will receive your Clinical Research College certificate.
  Good Clinical Practice in Clinical Research  
Section 1: An Introduction to Good Clinical Practice or GCP $99.99
Section 2: The Roles and Responsibilities of Ethics Committees $99.99
Section 3: The GCP Roles and Responsibilities of the Investigator $99.99
Section 4: The GCP Roles and Responsibilities of the Sponsor $99.99
Section 5 :GCP and the Clinical Trial Protocol and Protocol Amendments $99.99
Section 6 :GCP Essential Documents of a Clinical Trial $99.99
  Survivor Challenge for an FDA Audit and a GCP Inspection!  
Section 2: Preparation for a Good Clinical Practice Inspection and FDA Audit $99.99

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