Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 2: Investigator’s Responsibilities: Industry Sponsored Trials (2019)


  1. Topics
    1. ICH E6: (GCP)
  2. ICH E6 (R2): Good Clinical Practice
  3. Good Clinical Practice: Guidance for Industry
  4. ICH E6 (R2) Investigator
  5. Adequate Resources
  6. Records and Reports
  7. Investigators as Sponsors
    1. Quality Management
    2. Trial Management, Data Handling, and Record keeping
    3. Monitoring Plan


Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy |


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