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

Regulatory & Quality Sciences
Study & Site Management
Research & Study Conduct
Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 2: Investigator’s Responsibilities: Industry Sponsored Trials (2019)
Nancy Pire-Smerkanich, DRSc, MS

Assistant Professor, USC Mann Dept. of Regulatory and Quality Sciences; Associate Director, Regulatory Knowledge and Support

Topics

  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

Acknowledgement

Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy | atambe@usc.edu

Video Series

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