Course curriculum

  • 1

    Course Materials

    • Curriculum Outline

    • Course Schedule

    • Staff Emails

    • Course User Agreement
  • 2

    Lecture Recordings

    • Recordings by Date

    • Session 1 02/25 - M1, M2, M3 - Allen Savedra

    • Session 2 03/04 - M4, M5 - Joshua Ortiz

    • Session 3 03/11 - M5, M6 - Wenoah Veikley

    • Session 4 03/25 - M6 - Allen Savedra

    • Session 5 04/01 - M7 - Laura Herrera

    • Session 6 04/08 - M7, M8 - Wenoah Veikley

    • Session 7 04/15 - M8, M9 - Laura Herrera

    • Session 8 04/22 - M9, M10 - Sergio Guerrero

    • Session 9 04/29 - M10, M11 - Joshua Ortiz
  • 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

    • 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

  • 9

    Module 7 - Patient-Centered Trials: Informed Consent and Patient Experience

    • Lecture Slides - Module 7

    • Instructions - Module 7

    • ICF Ethics - Assignment

    • Informed Consent Forms Files*

    • Informed Consent Forms* - Assignment

    • Informed Consent Log* - Assignment

    • Screening/Enrollment/Subject ID Log* - Assignment

    • Subject Visit Tracking Log* - Assignment

    • Protocol Deviation Log* - Assignment

    • Subject Visit Tracking Log & Protocol Deviation Log Homework Walkthrough Video
  • 10

    Module 8 - Investigational Product Oversight: Ensuring Integrity & Safety

    • Lecture Slides - Module 8

    • Instructions - Module 8

    • Subject Drug Accountability Log* - Assignment

    • Sample Procurement & Tracking Log* - Assignment

    • IP Temperature & Storage Log* - Assignment

    • Homework Walkthrough Video M8

  • 11

    Module 9 - Clinical Trial Safety: AE/SAE Management & IRB Communication

    • Lecture Slides - Module 9

    • Instructions - Module 9

    • AE/SAE Tracking Log* - Assignment

    • IRB or Not? - Assignment

    • AE vs SAE - Assignment
  • 12

    Module 10 - Site Oversight & Closure: Navigating CRA Visits & End-of-Study Duties

    • Lecture Slides - Module 10
  • 13

    Module 11 - Professional Presence in Clinical Trials: Soft Skills for Effective Research Teams

    • Lecture Slides - Module 11

  • 14

    FINAL CAPSTONE PROJECT Submission

    • Instructions - Final Capstone

    • Additional Files for Final Capstone Project*

    • Daily Planner

    • Regulatory Binder Submission

    • Site Binder Submission

    • Capstone Walkthrough Video
  • 15

    GRADUATION!

    • Graduation Flyer and Registration Link