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Guide to Good Clinical Practice - Online

  • Directory

  • December 2024
  • Region: Global
  • Thompson FDA
  • ID: 5665716
The Guide to Good Clinical Practice is your one-stop resource for clinical trial regulations and guidelines - everything you need to conduct clinical trials more effectively, streamline the process and ensure human subject protection and trial data integrity. This resource is THE most comprehensive and straightforward resource of its kind.

Table of Contents

  • Tab 100 - Overview of Good Clinical Practice
  • Tab 200 - Investigator Obligations
  • Tab 300 - Information About Subjects
  • Tab 400 - Document Requirements
  • Tab 500 - Sponsor/Monitor Obligations
  • Tab 600 - Evaluation of Clinical Data
  • Tab 700 - Quality Assurance Audits
  • Tab 800 - Institutional Review Boards
  • Tab 900 - International Good Clinical Practice
  • Tab 1000 - Electronic Submissions, Computer Validation
  • Tab 1100 - FDA Monitoring
  • Tab 1200 - Other Federal Authorities