0140m
GCP Foundations and Principles
Overview of ICH GCP, scope, stakeholders, and core principles including ethics and participant protection.
- GCP overview and scope
- 11 principles of ICH GCP E6(R3)
Master clinical research through interactive courses and real-world scenarios. Earn verifiable certificates recognized by sponsors, CROs, and IRBs—completely free.
Enroll in minutes
Create your account—no credit card required.
Master Clinical Research
Interactive modules written by clinical research experts.
Receive your certificate
Get a verifiable credential the moment you finish.
We distilled ICH E6(R3) into nine comprehensive modules. Each combines narrative storytelling, regulatory interpretation, and practical worksheets so you can apply Good Clinical Practice the moment you finish.
Total Duration
6 hours
Self-paced, progress saved
Assessments
100+
Scenario-based questions
Built with senior CRAs, quality leads, and principal investigators.
Overview of ICH GCP, scope, stakeholders, and core principles including ethics and participant protection.
Investigator/site duties, sponsor/CRO obligations, and IRB/IEC oversight per E6(R3).
Process, documentation, and considerations for vulnerable populations under E6(R3).
Protocol adherence, deviations/amendments, and investigational product accountability.
AE/SAE/SUSAR definitions, reporting timelines, and medical care documentation.
Master data integrity principles including ALCOA++ (Attributable, Legible, Contemporaneous, Original, Accurate), source data verification, and electronic systems validation.
Comprehensive data governance framework covering the full data lifecycle, computerized systems validation, and safeguarding trial blinding per ICH E6(R3).
Risk-Based Quality Management (RBQM), Quality by Design (QbD), Critical to Quality (CtQ) factors, centralized monitoring, and CAPA implementation.
TMF organization, essential documents, noncompliance handling, and inspection readiness.
Every clinical trial hinges on a shared language of ethics, documentation, and oversight. The most recent ICH E6(R3) revision raises the bar—demanding smarter risk management, verified digital systems, and human-centred consent workflows.
FreeGCP was built as an open-access reference implementation of those expectations. We blend the rigour of regulatory source documents with annotated case studies and interactive exercises that translate policy into instinct.
The result: a credible credential for individuals and a scalable baseline for organizations who refuse to cut corners on participant safety or data integrity.
Clinical research professionals
CRAs, CRCs, data managers, site coordinators, and quality specialists who need proof of current GCP mastery.
Principal investigators & clinicians
Physicians, pharmacists, and allied health professionals entering or refreshing regulated research work.
Sponsor & CRO leadership
Regulatory, QA, and project leads who must maintain current GCP certification and compliance standards.
Create your free account to access the complete ICH E6(R3) curriculum, knowledge assessments, and professional certificate.
We re-engineered the ICH E6(R3) curriculum into an immersive learning experience: interactive modules, annotated guidelines, and real-world scenarios that mirror the realities of sponsor oversight. No paywalls, no watered-down summaries—just the training you actually need to step into a regulated role.
Credential
ICH E6(R3) Certificate
Issued instantly with QR verification and ledger logging.
Format
Interactive • Case studies • Quizzes
Designed for desktop deep work and mobile refreshers.
Self-paced comprehensive training
Interactive modules, annotated readings, and real-world scenarios crafted by senior CRAs.
Structured assessments
Lesson knowledge checks, module quizzes, and a comprehensive final exam aligned with sponsor expectations.
Instant industry credential
Receive a verifiable certificate with QR validation and ledger ID the moment you pass.
Community
Early feedback from the clinical research community
This will be a great asset to the clinical research community. The ICH E6(R3) focus and comprehensive curriculum coverage is exactly what we need for current GCP training standards.
Clinical Research Professional
Research Community Feedback
All certificates include QR codes and unique IDs for instant verification during audits and inspections.
Explore related topics to deepen your understanding
Begin the FreeGCP track now and earn your verifiable certification. Join coordinators, monitors, and investigators advancing their careers with ICH E6(R3) training.
Create your account in under a minute
Master clinical research through interactive courses and real-world scenarios. Earn verifiable certificates recognized by sponsors, CROs, and IRBs—completely free.
Enroll in minutes
Create your account—no credit card required.
Master Clinical Research
Interactive modules written by clinical research experts.
Receive your certificate
Get a verifiable credential the moment you finish.
We distilled ICH E6(R3) into nine comprehensive modules. Each combines narrative storytelling, regulatory interpretation, and practical worksheets so you can apply Good Clinical Practice the moment you finish.
Total Duration
6 hours
Self-paced, progress saved
Assessments
100+
Scenario-based questions
Built with senior CRAs, quality leads, and principal investigators.
Overview of ICH GCP, scope, stakeholders, and core principles including ethics and participant protection.
Investigator/site duties, sponsor/CRO obligations, and IRB/IEC oversight per E6(R3).
Process, documentation, and considerations for vulnerable populations under E6(R3).
Protocol adherence, deviations/amendments, and investigational product accountability.
AE/SAE/SUSAR definitions, reporting timelines, and medical care documentation.
Master data integrity principles including ALCOA++ (Attributable, Legible, Contemporaneous, Original, Accurate), source data verification, and electronic systems validation.
Comprehensive data governance framework covering the full data lifecycle, computerized systems validation, and safeguarding trial blinding per ICH E6(R3).
Risk-Based Quality Management (RBQM), Quality by Design (QbD), Critical to Quality (CtQ) factors, centralized monitoring, and CAPA implementation.
TMF organization, essential documents, noncompliance handling, and inspection readiness.
Every clinical trial hinges on a shared language of ethics, documentation, and oversight. The most recent ICH E6(R3) revision raises the bar—demanding smarter risk management, verified digital systems, and human-centred consent workflows.
FreeGCP was built as an open-access reference implementation of those expectations. We blend the rigour of regulatory source documents with annotated case studies and interactive exercises that translate policy into instinct.
The result: a credible credential for individuals and a scalable baseline for organizations who refuse to cut corners on participant safety or data integrity.
Clinical research professionals
CRAs, CRCs, data managers, site coordinators, and quality specialists who need proof of current GCP mastery.
Principal investigators & clinicians
Physicians, pharmacists, and allied health professionals entering or refreshing regulated research work.
Sponsor & CRO leadership
Regulatory, QA, and project leads who must maintain current GCP certification and compliance standards.
Create your free account to access the complete ICH E6(R3) curriculum, knowledge assessments, and professional certificate.
We re-engineered the ICH E6(R3) curriculum into an immersive learning experience: interactive modules, annotated guidelines, and real-world scenarios that mirror the realities of sponsor oversight. No paywalls, no watered-down summaries—just the training you actually need to step into a regulated role.
Credential
ICH E6(R3) Certificate
Issued instantly with QR verification and ledger logging.
Format
Interactive • Case studies • Quizzes
Designed for desktop deep work and mobile refreshers.
Self-paced comprehensive training
Interactive modules, annotated readings, and real-world scenarios crafted by senior CRAs.
Structured assessments
Lesson knowledge checks, module quizzes, and a comprehensive final exam aligned with sponsor expectations.
Instant industry credential
Receive a verifiable certificate with QR validation and ledger ID the moment you pass.
Community
Early feedback from the clinical research community
This will be a great asset to the clinical research community. The ICH E6(R3) focus and comprehensive curriculum coverage is exactly what we need for current GCP training standards.
Clinical Research Professional
Research Community Feedback
All certificates include QR codes and unique IDs for instant verification during audits and inspections.
Explore related topics to deepen your understanding
Begin the FreeGCP track now and earn your verifiable certification. Join coordinators, monitors, and investigators advancing their careers with ICH E6(R3) training.
Create your account in under a minute