Course curriculum

  • 1

    Course Materials

    • Curriculum Outline

    • Course Schedule

    • Course User Agreement

    • Session 1 10/15 - M1, M2, M3 - Allen Savedra

    • Session 2 10/22 - M4, M5 - Joshua Ortiz

    • Session 3 10/29 - M5, M6 - Allen Savedra

    • Session 4 11/05 - M6 - Allen Savedra

    • Session 5 11/12 - M7 - Laura Herrera

    • Session 6 11/19 - M7, M8 - Laura Herrera

    • Session 7 12/3 - M8, M9 - Allen Savedra

    • Session 8 12/10 - M9, M10 - Joshua Ortiz

    • Session 9 12/17 - M11 - Laura Herrera

    • Subject Visit Tracking Log Explained

    • Adding Links to the Table of Contents
  • 2

    Module 1 - Drug Development & Clinical Trial Process Review

    • Module 1

    • Clinical Trial Phases
  • 3

    Module 2 - Good Clinical Practice (GCP) Review

    • Module 2

    • ICH GCP Principles
  • 4

    Module 3 - CRC Role in Focus

    • Module 3

    • Study & Team Introduction
  • 5

    Module 4 - Assessing Site Readiness: Criteria for Trial Launch

    • Module 4

    • Module 4 Files

    • Instructions Module 4

    • CAPA Form
  • 6

    Module 5 - Study Start-up & Operational Readiness

    • Module 5

    • Colorectal Cancer Protocol - Example in Lecture

    • Module 5 Resources

    • Instructions Module 5

    • IP SOP
  • 7

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

    • Module 6

    • Module 6 Resources

    • Sarah Jones, MD - PI Documents

    • Mayra Reed, RN - Sub-I Documents

    • Elliot Maine, CRC Documents

    • Student, CRC Documents

    • Instructions Module 6

    • Form 1572

    • Monitoring Log Complete

    • NTF

    • Site Binder
  • 8

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

    • Module 7

    • Module 7 Resources

    • Instructions Module 7

    • Informed Consent Log

    • Enrollment/Screening/Subject ID Log

    • Subject Visit Tracking Log

    • Protocol Deviation Log

    • ICF Ethics
  • 9

    Module 8 - Investigational Product Oversight: Ensuring Integrity & Safety

    • Module 8

    • Module 8 Resources

    • Instructions Module 8

    • Sample Procurement & Tracking Log

    • IP Temperature & Storage Log
  • 10

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

    • Module 9

    • Module 9 Resources

    • Instructions

    • IRB or Not?

    • AE vs SAE

  • 11

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

    • Module 10

    • Final Capstone Instructions and Resources

  • 12

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

    • Module 11

  • 13

    FINAL CAPSTONE PROJECT Submission

    • Regulatory Binder Submission

    • Site Binder Submission

    • Daily Planner