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Curriculum guide

GCP training, course by course.

See exactly what you will study before you enroll: two courses, the modules in order, every lesson, where the knowledge checks fall, and the exams at the end.

Open the GCP trackRead a sample lesson
Course sequence · updates with the track
Courses
2
Modules
16
Lessons
61
Estimated time
25 hours

The curriculum

What each course covers

Every course, module, and lesson in the order you will study them. The list updates with the track itself.

Course 01 · Optional

Clinical Research Foundations

Master the fundamentals of clinical trials and research before diving into GCP certification.

8 modules · 29 lessons

  1. What Is Clinical Research?

    3 lessons · module check

  2. The Ethical Foundations of Human Research

    3 lessons · module check

  3. The Drug Development Pipeline

    4 lessons · module check
    • Discovery and Preclinical Research
    • The IND and Clinical Development
    • Regulatory Review and Approval
    • Beyond Approval: Post-Marketing

  4. Understanding Clinical Trial Phases

    4 lessons · module check
    • Phase I: First-in-Human Studies
    • Phase II: Proof of Concept
    • Phase III: Pivotal Trials
    • Phase IV and Beyond

  5. The People Behind Clinical Trials

    4 lessons · module check

  6. The Participant Journey

    4 lessons · module check
    • Finding and joining a trial
    • Understanding Informed Consent
    • Managing participant visits and ongoing engagement
    • Study completion and beyond

  7. Regulatory Oversight and Quality

    4 lessons · module check
    • The Regulatory Landscape
    • ICH and International Harmonization
    • Good Clinical Practice: An Introduction
    • When Things Go Wrong: Inspections and Enforcement

  8. Your Future in Clinical Research

    3 lessons · module check

  9. Course exam

    Clinical Research Foundations Final Exam

    60 questions · 80% passing score · 60 minute limit · 3 attempts

Course 02 · Required

ICH E6(R3) Principles

Master the complete ICH E6(R3) guideline — quality-by-design principles, risk-based approaches, and the regulatory framework governing clinical trial conduct worldwide.

8 modules · 32 lessons

  1. Introduction to GCP and ICH E6(R3)

    4 lessons · module check

  2. Ethical Principles and Participant Protection

    4 lessons · module check
    • Principle 1: Ethical Conduct and Participant Protection
    • Principle 2: Informed Consent Fundamentals
    • Diversity, Inclusion, and Vulnerable Populations
    • Decentralized and Technology-Enabled Consent

  3. Trial Oversight: IRB/IEC, Science, and Qualifications

    4 lessons · module check
    • Principle 3: Independent IRB/IEC review
    • Principle 4: Scientific soundness
    • Principle 5: Qualified individuals
    • IRB/IEC operations in practice

  4. Quality, Proportionality, and Protocol Design

    4 lessons · module check

  5. Reliable Results, Roles, and Product Management

    4 lessons · module check
    • Principle 9: Reliable results
    • Principle 10: Roles and responsibilities
    • Principle 11: Investigational products
    • Fit-for-purpose systems and computerized systems validation

  6. Investigator Responsibilities: Qualifications to Protocol Compliance

    4 lessons · module check
    • Qualifications, training, and resources
    • Responsibilities and delegation
    • Communication with IRB/IEC
    • Protocol compliance and premature termination

  7. Investigator Responsibilities: Safety, Consent, and Product Management

    4 lessons · module check
    • Medical care and safety reporting
    • Informed consent of trial participants
    • End of participation and IP management
    • Randomization and unblinding

  8. Records, Reports, and Data Governance

    4 lessons · module check
    • Records and source documentation
    • Reports to IRB/IEC and sponsor
    • Data governance fundamentals
    • Computerized systems requirements

  9. Course exam

    ICH E6(R3) GCP Certificate Exam

    60 questions · 80% passing score · 90 minute limit · 3 attempts

How it is taught

A sequence you can inspect before you begin.

Read the material in order, use the knowledge checks to see what to review, then pass each course exam.

  1. 01

    Study the sequence

    61 lessons are grouped into 16 modules, so you always know what comes next.

  2. 02

    Check your understanding as you go

    0 lesson checks and 16 module checks are built into the track.

  3. 03

    Pass the course exams

    2 course exams close the sequence. The credential guide explains how your record is issued once the required work is done.

What you will learn

What you will be able to do

These outcomes come from the GCP track itself. The course list above shows the material behind each one.

  1. 01

    Demonstrate GCP competency to sponsors and institutions

    Earn a verifiable credential that demonstrates you meet GCP training expectations for clinical trial participation.

  2. 02

    Master the complete ICH E6(R3) guidelines

    From foundational ethics through RBQM, Quality by Design, data governance, and inspection readiness.

  3. 03

    Protect participant rights and safety in clinical trials

    Understand informed consent, safety reporting, and the ethical principles that underpin all clinical research.

  4. 04

    Maintain data integrity with ALCOA++ principles

    Learn the documentation standards that regulators and monitors expect at every site visit.

  5. 05

    Prepare for monitoring visits and regulatory inspections

    Know what inspectors look for and how to maintain inspection-ready documentation at all times.

  6. 06

    Build a foundation for specialized clinical research roles

    GCP certification is the prerequisite for CRC, MSL, regulatory, and other advanced training tracks.

Questions

Before you start

Answers about the curriculum. The credential guide covers records and verification.

What does the GCP training cover?
The track has two courses: Clinical Research Foundations and ICH E6(R3) Principles. Each one is split into modules and lessons, and the whole sequence is listed on this page so you can read it before you enroll.
How long does it take?
About 25 hours of study. The track is self-paced, so you can stop and pick up where you left off.
Is the training free?
Yes. GCP training is free, including all course material, quizzes, exams, and the online verification URL. The optional TransCelerate-recognized PDF certificate is $29 USD.
Are there exams?
Yes. Two course exams close the sequence, with a 80% passing score. Short knowledge checks along the way tell you what to review before you get there.
Can I preview a lesson before enrolling?
Yes. The lessons you can read before enrolling are linked in the course list on this page. Open one and read it in full.
Do I get a certificate?
When you finish, you get a completion record with a public verification page that anyone can check in seconds. The printable PDF certificate is optional. The credential guide explains both.

Next step

Read the syllabus, then start.

Open the track to enroll, or read the credential guide to see how completion and verification work.

Open the GCP trackRead the credential guide