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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
  • 3During the trial: visits, procedures, and rights
  • 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
9 modules
27 lessons
1

GCP Foundations and Principles

  • 1GCP Overview and Scope
  • 2GCP Principles and Ethics
  • 3The 11 Principles of ICH GCP (E6 R3)
  • Module Quiz10 questions
2

Roles and Responsibilities

  • 1Investigator and Site Responsibilities
  • 2Sponsor and CRO Responsibilities
  • 3IRB/IEC Oversight
  • 4Investigator Qualifications, Training, and Resources
  • Module Quiz10 questions
3

Informed Consent

  • 1The Informed Consent Process
  • 2Vulnerable Populations and Consent Documentation
  • Module Quiz10 questions
4

Protocol and Trial Conduct

  • 1Protocol Conduct, Deviations, and Amendments
  • 2Investigational Product Accountability
  • 3Randomization and Unblinding
  • 4End of Participation and Early Termination/Suspension
  • Module Quiz10 questions
5

Safety Reporting

  • 1AE/SAE/SUSAR: Definitions and Reporting
  • 2Safety Management and Timelines
  • 3Medical Care of Trial Participants
  • Module Quiz10 questions
6

Data Integrity and Records

  • 1Source Data, CRF/eCRF, and ALCOA++
  • 2Electronic Systems and Validation
  • Module Quiz10 questions
7

Data Governance — Investigator and Sponsor

  • 1Data Governance Overview and Lifecycle
  • 2Safeguarding Blinding in Data Handling
  • 3Computerized Systems: Responsibilities and User Management
  • Module Quiz10 questions
8

Quality Management and Monitoring (RBQM)

  • 1QMS, RBQM, and Quality by Design
  • 2Monitoring: Centralized and Onsite
  • 3Risk Assessment and Mitigation
  • Module Quiz10 questions
9

Essential Documents and Inspections

  • 1Essential Documents and the TMF
  • 2Inspection Readiness and Noncompliance
  • 3Study Completion and Reporting
  • Module Quiz10 questions
Designed For
Clinical Research CoordinatorResearch NurseStudy CoordinatorSite StaffAll Roles

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