Regulatory Management Reference Materials

General References

• Spreadsheet of all HUM Application questions spreadsheet (last updated 3/2/2021)
• Spreadsheet of all Multi-Site Research application questions spreadsheet (last updated 4/29/2020)
• Spreadsheet of all Amendment application questions spreadsheet (last updated 4/29/2020)
• Spreadsheet of all AE/ORIO application questions spreadsheet (last updated 4/29/2020)
• Spreadsheet of all SCR application questions spreadsheet (last updated 5/22/2014)
• Human Subjects research study review process pdf

Step-by-Step Procedures by Role or Application

• Human Subjects Application
  • PI & Study Team Support
  • Core IRB Staff Support
  • Core Committee Member/Reviewer Support
  • Ancillary Committee Member/Reviewer Support
• Institutional Biosafety Committee (IBC) Application Support
• Repository Application Support
• Participating Site Application Support

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