Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 3: Investigator’s Responsibilities: Investigator Initiated Trials (2019)

Regulatory & Quality Sciences
Study & Site Management
Research & Study Conduct
Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 3: Investigator’s Responsibilities: Investigator Initiated 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. Form 1572
    2. 21 CFR 312.50
  2. What is FDA form 1572?
    1. Statement of Investigator
  3. When don’t we use the 1572?
    1. Investigation Device Studies
    2. Non-IND Studies
  4. Why does the Investigator need to fill it out?
    1. Dual Purpose 
  5. FDA Form 1572 and FAQs
    1. Guidance for sponsors, investigators and IRBs
  6. 1572 Commitments
  7. When to sign the 1572?
  8. The “Legal” Part
  9. 1572 Commitments
  10. Statement of Investigator
  11. Binding Agreement
  12. Helpful Reference!
  13. 21 CFR 312.50
    1. General responsibilities of sponsors

Acknowledgement

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

Video Series

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