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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.
Focused modules on risk-based quality management, data governance, and regulatory compliance.
Professional calculators, assessment tools, and study materials—all free.
Understand the structure and key changes in ICH E6(R3) and how they impact clinical trial conduct.
Learn the fundamental principles of GCP and why these guidelines are essential for ethical clinical research.
Master the critical requirements for identifying, documenting, and reporting adverse events to ensure participant safety.
Ensure thorough and consistent routine monitoring visits with this comprehensive CRA checklist covering all essential review areas.
Quick reference for SAE reporting timelines from investigator notification through regulatory submission.
Quick guide to clinical trial roles, responsibilities, and qualifications from sponsor to site staff.
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.
Focused modules on risk-based quality management, data governance, and regulatory compliance.
Professional calculators, assessment tools, and study materials—all free.
Understand the structure and key changes in ICH E6(R3) and how they impact clinical trial conduct.
Learn the fundamental principles of GCP and why these guidelines are essential for ethical clinical research.
Master the critical requirements for identifying, documenting, and reporting adverse events to ensure participant safety.
Ensure thorough and consistent routine monitoring visits with this comprehensive CRA checklist covering all essential review areas.
Quick reference for SAE reporting timelines from investigator notification through regulatory submission.
Quick guide to clinical trial roles, responsibilities, and qualifications from sponsor to site staff.
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.
Access free courses, tools, and resources to build your foundation. Upgrade to Professional for premium content, advanced features, and career services.
Free
Free courses, tools, and resources to build your clinical research foundation—no credit card required.
forever
Instant access · No credit card
Professional
Unlock premium courses, advanced tools, exclusive resources, and career services—plus priority support.
per month (billed annually)· Save $120
Then $348/year · Cancel anytime
All certificates include QR codes and unique IDs for instant verification during audits and inspections.
A private circle of distinguished leaders shaping the future of global clinical research.
Admission by application only. Fewer than 5% of applicants are accepted. We seek exceptional professionals with 10+ years of experience whose accomplishments align with our commitment to advancing global standards in drug development and patient safety.
An intimate community of distinguished peers shaping the future of clinical research.
First access to emerging methodologies, tools, and frameworks—months before general release.
Permanent recognition as a founding member of the GCP Fellowship.
Fellows-only templates, SOPs, and strategic frameworks curated to the highest standards.
Annual gatherings in prestigious international venues with fellow industry luminaries.
Direct connections with leaders in clinical ops, medical affairs, biostatistics, regulatory, and more.
Co-authorship on industry white papers, thought leadership, and scientific commentaries.
Your name permanently enshrined in the GCP Fellows registry.
By Application Only
If you believe your background and aspirations align with the GCP Fellowship mission, we invite you to submit an application for consideration. Acceptance is not guaranteed—we carefully review each candidate to maintain the caliber of our community.
Acceptance Not Guaranteed
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
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.
Access free courses, tools, and resources to build your foundation. Upgrade to Professional for premium content, advanced features, and career services.
Free
Free courses, tools, and resources to build your clinical research foundation—no credit card required.
forever
Instant access · No credit card
Professional
Unlock premium courses, advanced tools, exclusive resources, and career services—plus priority support.
per month (billed annually)· Save $120
Then $348/year · Cancel anytime
All certificates include QR codes and unique IDs for instant verification during audits and inspections.
A private circle of distinguished leaders shaping the future of global clinical research.
Admission by application only. Fewer than 5% of applicants are accepted. We seek exceptional professionals with 10+ years of experience whose accomplishments align with our commitment to advancing global standards in drug development and patient safety.
An intimate community of distinguished peers shaping the future of clinical research.
First access to emerging methodologies, tools, and frameworks—months before general release.
Permanent recognition as a founding member of the GCP Fellowship.
Fellows-only templates, SOPs, and strategic frameworks curated to the highest standards.
Annual gatherings in prestigious international venues with fellow industry luminaries.
Direct connections with leaders in clinical ops, medical affairs, biostatistics, regulatory, and more.
Co-authorship on industry white papers, thought leadership, and scientific commentaries.
Your name permanently enshrined in the GCP Fellows registry.
By Application Only
If you believe your background and aspirations align with the GCP Fellowship mission, we invite you to submit an application for consideration. Acceptance is not guaranteed—we carefully review each candidate to maintain the caliber of our community.
Acceptance Not Guaranteed
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