Course curriculum

  • 1

    INSTRUCTIONS FOR THIS COURSE

    • Instructions for the course: ICH GCP E6 (R2) for Investigators and Clinical Research Staff

    • Table of Acronyms
  • 2

    MODULE 1 - Clinical Research Regulations and Guidelines

    • MODULE 1 - Clinical Research Regulations and Guidelines
  • 3

    MODULE 2 - GCP Overview

    • MODULE 2 - GCP Overview
  • 4

    MODULE 3 - The Principles of ICH GCP

    • MODULE 3 - The Principles of ICH GCP
  • 5

    MODULE 4 - Investigator's Responsibilities

    • SECTION 4.1 - Investigator's Qualifications and Agreements

    • SECTION 4.2 - Adequate Resources

    • SECTION 4.3 - Medical Care of Trial Subjects

    • SECTION 4.4 - Communication with IRB/IEC

    • SECTION 4.5 - Compliance with Protocol

    • SECTION 4.6 - Investigational Product(s)

    • SECTION 4.7 - Randomization Procedures and Unblinding

    • Section 4.8 - Informed Consent of Trial Subjects

    • Section 4.9 - Records and Reports

    • Section 4.10 - Progress and Final Reports

    • Section 4.11 - Safety Reporting

    • SECTION 4.12 - Premature Termination or Suspension of a Trial
  • 6

    KEY MESSAGES

    • The Importance of GCP
  • 7

    FINAL ASSESSMENT

    • Course Quiz