Course curriculum

  • 1

    Drug Development & Clinical Trial Process Review

    • Module 1

    • Module 1 Assignment

  • 2

    Good Clinical Practice (GCP) Review

    • Module 2

    • Module 2 Assignment

  • 3

    CRC Role & Focus

    • Module 3

    • Module 3 Resources
  • 4

    Study Startup & Operational Readiness

    • Instructions

    • Module 5 Resources
  • 5

    Building the Binder: Documentation Standards & Quality Oversight

    • Instructions

    • Module 6 Resources

    • Sarah Jones, MD - PI Documents

    • Mayra Reed, RN - Sub-I Documents

    • Elliot Maine, CRC Documents

    • Student, CRC Documents

  • 6

    Patient Centered Trials: Informed Consent & Patient Experience

    • Instructions

    • Module 7 Resources

  • 7

    Investigational Product Oversight: Ensuring Integrity & Safety

    • Instructions

    • Module 8 Resources

  • 8

    Clinical Trial Safety: AE/SAE Management & IRB Communication

    • Instructions

    • Module 9 Resources

  • 9

    Site Oversight & Closure: Navigating CRA Visits & End-of-Study Duties

    • FINAL CAPSTONE PROJECT Instructions

    • Module 10 Resources