Investigator Responsibilities: Industry Sponsored Trials

Topics: 
  • E6(R2): Good Clinical Practice: Integrated Addendum to ICH (International Council for Harmonisation) E6(R1): Guidance for Industry
  • INVESTIGATOR (4)
  • Adequate Resources (4.2)
  • Records and Reports (4.9)
  • SPONSORS (5)
  • Quality Management (5.0)
  • Trial Management, Data Handling, and Record Keeping (5.5)
  • Monitoring Plan (5.18)
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