Course curriculum

  • 1

    Course Materials

    • Curriculum Outline

    • Course Schedule

    • Staff Emails

    • Course User Agreement
  • 2

    Lecture Recordings

    • Recordings by Date

    • Session 1 - M1, M2, M3 - Sergio Guerrero

    • Session 2 - M4, M5 - Allen Savedra

    • Session 3 - M5 - Sergio Guerrero

  • 3

    Module 1 - Drug Development & Clinical Trial Process Review

    • Lecture Slides - Module 1

    • Clinical Trial Phases - Assignment

  • 4

    Module 2 - Good Clinical Practice (GCP) Review

    • Lecture Slides - Module 2

    • ICH GCP Principles - Assignment

  • 5

    Module 3 - CRC Role in Focus

    • Lecture Slides - Module 3

    • Study Team Introduction

    • Study Protocol V1*

    • Modules 1, 2, and 3 RECAP - Assignment

  • 6

    Module 4 - Assessing Site Readiness: Criteria for Trial Launch

    • Lecture Slides - Module 4

    • Instructions - Module 4

    • CAPA Form* - Assignment

    • Protocol Deviation Log* - Assignment

  • 7

    Module 5 - Study Start-up & Operational Readiness

    • Lecture Slides - Module 5

    • Colorectal Cancer Protocol - Example in Lecture - NOT FOR ASSIGNMENTS

    • Instructions - Module 5

    • ALCOA-C+ - Assignment

    • AE, SAE, ICF SOPs*

    • IP SOP* - Assignment
  • 8

    Module 6 - Building the Binder: Documentation Standards & Quality Oversight

    • Lecture Slides - Module 6

    • Instructions - Module 6

    • Site Binder Files*

    • Site Binder* - Assignment

    • Delegation Log* - Assignment

    • Form 1572* - Assignment

    • Monitoring Log* - Assignment

    • NTF* - Assignment

    • Homework Walkthrough Video