Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 2: Investigator’s Responsibilities: Industry Sponsored Trials (2019)


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


Instructors

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.