Considerations When Transfering Clinical Investigation Oversight to Another irb

Document Outline

• Considerations When Transferring Clinical Investigation Oversight to Another IRB
• U.S. Department of Health and Human Services
• Considerations When Transferring Clinical Investigation Oversight to Another IRB
• Additional copies are available from:
• Office of Communication, Outreach and
• U.S. Department of Health and Human Services
• TABLE OF CONTENTS
• Guidance for IRBs, Clinical Investigators and Sponsors0F
• I. INTRODUCTION
• II.   BACKGROUND
• III.  WHEN OVersight of a Previously Approved Clinical Investigation TRANSFERS FROM THE ORIGINAL IRB TO ANother IRB Not part of the same INSTITUTION
• IV. Special Situations
  • A.  Transfer of IRB Oversight from one IRB to Another IRB within the Same Institution and Temporary Transfer of IRB Review Responsibility
  • B.  Transfer of a Clinical Investigation to a New Research Site Requiring IRB Review
• V.   ADDITIONAL QUESTIONS about transferring OVERSIGHT OF A clinical investigation