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FreeGCP
Free Learning Track

Good Clinical Practice (GCP)

Rigorous ICH E6(R3)-aligned training for clinical research professionals

Track Curriculum

2 courses in this track

Complete these courses in order to earn your track certificate.

1

Clinical Research Foundations

View Course Details
8 modules
29 lessons
1

What Is Clinical Research?

  • 1The Quest for Medical Evidence
  • 2Types of Clinical Research
  • 3Why Clinical Trials Matter
  • Module Quiz10 questions
2

The Ethical Foundations of Human Research

  • 1Lessons from History
  • 2The Belmont Report and Core Principles
  • 3From Principles to Practice
  • Module Quiz10 questions
3

The Drug Development Pipeline

  • 1Discovery and Preclinical Research
  • 2The IND and Clinical Development
  • 3Regulatory Review and Approval
  • 4Beyond Approval: Post-Marketing
  • Module Quiz10 questions
4

Understanding Clinical Trial Phases

  • 1Phase I: First-in-Human Studies
  • 2Phase II: Proof of Concept
  • 3Phase III: Pivotal Trials
  • 4Phase IV and Beyond
  • Module Quiz10 questions
5

The People Behind Clinical Trials

  • 1Sponsors and Contract Research Organizations
  • 2Investigators and Site Staff
  • 3Ethics Committees and Regulatory Authorities
  • 4Participants: The Heart of Clinical Research
  • Module Quiz10 questions
6

The Participant Journey

  • 1Finding and joining a trial
  • 2Understanding Informed Consent
  • 3Managing participant visits and ongoing engagement
  • 4Study completion and beyond
  • Module Quiz10 questions
7

Regulatory Oversight and Quality

  • 1The Regulatory Landscape
  • 2ICH and International Harmonization
  • 3Good Clinical Practice: An Introduction
  • 4When Things Go Wrong: Inspections and Enforcement
  • Module Quiz10 questions
8

Your Future in Clinical Research

  • 1Career roles in clinical research
  • 2Education and Certification Pathways
  • 3Breaking In: Practical Strategies
  • Module Quiz10 questions
2

ICH E6(R3) Principles

View Course Details
8 modules
32 lessons
1

Introduction to GCP and ICH E6(R3)

  • 1What is Good Clinical Practice?
  • 2Historical and Ethical Foundations of GCP
  • 3The Global Regulatory Landscape
  • 4Structure and Scope of ICH E6(R3)
  • Module Quiz10 questions
2

Ethical Principles and Participant Protection

  • 1Principle 1: Ethical Conduct and Participant Protection
  • 2Principle 2: Informed Consent Fundamentals
  • 3Diversity, Inclusion, and Vulnerable Populations
  • 4Decentralized and Technology-Enabled Consent
  • Module Quiz10 questions
3

Trial Oversight: IRB/IEC, Science, and Qualifications

  • 1Principle 3: Independent IRB/IEC review
  • 2Principle 4: Scientific soundness
  • 3Principle 5: Qualified individuals
  • 4IRB/IEC operations in practice
  • Module Quiz10 questions
4

Quality, Proportionality, and Protocol Design

  • 1Principle 6: Quality by design
  • 2Principle 7: Proportionate approach
  • 3Principle 8: Protocol requirements
  • 4Implementing RBQM: A practical framework
  • Module Quiz10 questions
5

Reliable Results, Roles, and Product Management

  • 1Principle 9: Reliable results
  • 2Principle 10: Roles and responsibilities
  • 3Principle 11: Investigational products
  • 4Fit-for-purpose systems and computerized systems validation
  • Module Quiz10 questions
6

Investigator Responsibilities: Qualifications to Protocol Compliance

  • 1Qualifications, training, and resources (2.1-2.2)
  • 2Responsibilities and delegation (2.3)
  • 3Communication with IRB/IEC (2.4)
  • 4Protocol compliance and premature termination (2.5-2.6)
  • Module Quiz10 questions
7

Investigator Responsibilities: Safety, Consent, and Product Management

  • 1Medical care and safety reporting (2.7)
  • 2Informed consent of trial participants (2.8)
  • 3End of participation and IP management (2.9-2.10)
  • 4Randomization and unblinding (2.11)
  • Module Quiz10 questions
8

Records, Reports, and Data Governance

  • 1Records and source documentation (2.12)
  • 2Reports to IRB/IEC and sponsor (2.13)
  • 3Data governance fundamentals (Section 4)
  • 4Computerized systems requirements (Section 4.3)
  • Module Quiz10 questions
Designed For
Clinical Research CoordinatorResearch NurseStudy CoordinatorSite StaffAll Roles

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