GCP Foundations and Principles
3 lessons · 135 minutes
1.1 GCP Overview and Scope
What ICH GCP is, who it applies to, and how E6(R3) frames scope and applicability across clinical trials.
A focused, practical introduction to ICH GCP E6(R3) designed to get learners productive in clinical research quickly. Covers core principles, roles and responsibilities, participant protection, trial conduct, safety, data integrity, RBQM/monitoring, and inspection readiness.
Duration
6 hours
Structure
9 modules · 27 lessons
Recognition
Certificate · 12,847+ enrolled
Explore each chapter before you enroll. Lessons stay locked until you sign in, but the outline reveals the exact scope sponsors expect.
3 lessons · 135 minutes
1.1 GCP Overview and Scope
What ICH GCP is, who it applies to, and how E6(R3) frames scope and applicability across clinical trials.
A focused, practical introduction to ICH GCP E6(R3) designed to get learners productive in clinical research quickly. Covers core principles, roles and responsibilities, participant protection, trial conduct, safety, data integrity, RBQM/monitoring, and inspection readiness.
Duration
6 hours
Structure
9 modules · 27 lessons
Recognition
Certificate · 12,847+ enrolled
Explore each chapter before you enroll. Lessons stay locked until you sign in, but the outline reveals the exact scope sponsors expect.
3 lessons · 135 minutes
1.1 GCP Overview and Scope
What ICH GCP is, who it applies to, and how E6(R3) frames scope and applicability across clinical trials.
1.2 GCP Principles and Ethics
The ethical underpinnings and key principles of ICH GCP E6(R3), including participant protection and data reliability.
1.3 The 42 Principles of ICH GCP (E6 R3)
Understanding and applying the 42 ICH GCP principles through real-world scenarios and practical examples.
4 lessons · 180 minutes
2.1 Investigator and Site Responsibilities
Investigator oversight, delegation, qualified staff, adequate resources, and control of the trial at the site.
2.2 Sponsor and CRO Responsibilities
Understanding sponsor accountability, CRO partnerships, quality management systems, and how sponsor oversight impacts site operations.
2.3 IRB/IEC Oversight
Understanding ethics committee oversight, the approval process, ongoing communications, and how to maintain a productive partnership with your IRB/IEC.
2.4 Investigator Qualifications, Training, and Resources
Understanding what makes an investigator qualified, how to demonstrate competence, and ensuring adequate resources for quality trial conduct.
2 lessons · 90 minutes
3.1 The Informed Consent Process
Understanding informed consent as an ongoing process, from first contact through trial completion, with practical guidance on documentation and communication.
3.2 Vulnerable Populations and Consent Documentation
Special considerations and documentation standards for vulnerable populations and complex scenarios.
4 lessons · 180 minutes
4.1 Protocol Conduct, Deviations, and Amendments
Following the approved protocol, managing deviations, and implementing amendments responsibly.
4.2 Investigational Product Accountability
Receipt, storage, dispensing, reconciliation, and return/destruction per E6(R3).
4.3 Randomization and Unblinding
Following randomization procedures and ensuring capability to unblind without delay; document premature unblinding (E6(R3) 2.11).
4.4 End of Participation and Early Termination/Suspension
Managing participant withdrawal/end of participation and investigator responsibilities for early termination/suspension (E6(R3) 2.6, 2.9).
3 lessons · 135 minutes
5.1 AE/SAE/SUSAR: Definitions and Reporting
Safety event definitions and fundamentals of reporting obligations and pathways.
5.2 Safety Management and Timelines
Managing safety information flow and meeting reporting timelines and documentation requirements.
5.3 Medical Care of Trial Participants
Qualified medical oversight, appropriate care for AEs and lab deviations, and communication with primary physicians per participant permission (E6(R3) 2.7.1).
2 lessons · 90 minutes
6.1 Source Data, CRF/eCRF, and ALCOA++
Data integrity expectations and practical application of ALCOA++ across source and CRFs.
6.2 Electronic Systems and Validation
Fit-for-purpose validation, access control, audit trails, and data governance for eSystems.
3 lessons · 135 minutes
7.1 Data Governance Overview and Lifecycle
Proportionate governance across the full data lifecycle; confidentiality, integrity, and traceability responsibilities (E6(R3) 4.2).
7.2 Safeguarding Blinding in Data Handling
Define roles, responsibilities, and procedures for access to unblinded information; mitigation against inadvertent unblinding (E6(R3) 4.1).
7.3 Computerized Systems: Responsibilities and User Management
Clarifies responsibilities and expectations for computerized systems: training, security, validation, release, failure handling, support, and user management (E6(R3) 4.3).
3 lessons · 135 minutes
8.1 QMS, RBQM, and Quality by Design
Establishing a quality management system with risk-proportionate controls and QbD.
8.2 Monitoring: Centralized and Onsite
Designing proportionate monitoring strategies, including centralized and onsite activities.
8.3 Risk Assessment and Mitigation
Identifying, assessing, and mitigating risks, with ongoing review and CAPA where needed.
3 lessons · 135 minutes
9.1 Essential Documents and the TMF
Organizing and maintaining essential documents in the TMF to reconstruct trials.
9.2 Inspection Readiness and Noncompliance
Preparing for inspections, addressing noncompliance, and driving effective CAPA.
9.3 Study Completion and Reporting
Provide all required reports to sponsor; submit final report/summary to IRB/IEC and regulators as required (E6(R3) 2.13).
Create your free account, unlock the full curriculum, and download your certificate the moment you finish.
No credit card · Verified credential · Progress saves automatically
1.2 GCP Principles and Ethics
The ethical underpinnings and key principles of ICH GCP E6(R3), including participant protection and data reliability.
1.3 The 42 Principles of ICH GCP (E6 R3)
Understanding and applying the 42 ICH GCP principles through real-world scenarios and practical examples.
4 lessons · 180 minutes
2.1 Investigator and Site Responsibilities
Investigator oversight, delegation, qualified staff, adequate resources, and control of the trial at the site.
2.2 Sponsor and CRO Responsibilities
Understanding sponsor accountability, CRO partnerships, quality management systems, and how sponsor oversight impacts site operations.
2.3 IRB/IEC Oversight
Understanding ethics committee oversight, the approval process, ongoing communications, and how to maintain a productive partnership with your IRB/IEC.
2.4 Investigator Qualifications, Training, and Resources
Understanding what makes an investigator qualified, how to demonstrate competence, and ensuring adequate resources for quality trial conduct.
2 lessons · 90 minutes
3.1 The Informed Consent Process
Understanding informed consent as an ongoing process, from first contact through trial completion, with practical guidance on documentation and communication.
3.2 Vulnerable Populations and Consent Documentation
Special considerations and documentation standards for vulnerable populations and complex scenarios.
4 lessons · 180 minutes
4.1 Protocol Conduct, Deviations, and Amendments
Following the approved protocol, managing deviations, and implementing amendments responsibly.
4.2 Investigational Product Accountability
Receipt, storage, dispensing, reconciliation, and return/destruction per E6(R3).
4.3 Randomization and Unblinding
Following randomization procedures and ensuring capability to unblind without delay; document premature unblinding (E6(R3) 2.11).
4.4 End of Participation and Early Termination/Suspension
Managing participant withdrawal/end of participation and investigator responsibilities for early termination/suspension (E6(R3) 2.6, 2.9).
3 lessons · 135 minutes
5.1 AE/SAE/SUSAR: Definitions and Reporting
Safety event definitions and fundamentals of reporting obligations and pathways.
5.2 Safety Management and Timelines
Managing safety information flow and meeting reporting timelines and documentation requirements.
5.3 Medical Care of Trial Participants
Qualified medical oversight, appropriate care for AEs and lab deviations, and communication with primary physicians per participant permission (E6(R3) 2.7.1).
2 lessons · 90 minutes
6.1 Source Data, CRF/eCRF, and ALCOA++
Data integrity expectations and practical application of ALCOA++ across source and CRFs.
6.2 Electronic Systems and Validation
Fit-for-purpose validation, access control, audit trails, and data governance for eSystems.
3 lessons · 135 minutes
7.1 Data Governance Overview and Lifecycle
Proportionate governance across the full data lifecycle; confidentiality, integrity, and traceability responsibilities (E6(R3) 4.2).
7.2 Safeguarding Blinding in Data Handling
Define roles, responsibilities, and procedures for access to unblinded information; mitigation against inadvertent unblinding (E6(R3) 4.1).
7.3 Computerized Systems: Responsibilities and User Management
Clarifies responsibilities and expectations for computerized systems: training, security, validation, release, failure handling, support, and user management (E6(R3) 4.3).
3 lessons · 135 minutes
8.1 QMS, RBQM, and Quality by Design
Establishing a quality management system with risk-proportionate controls and QbD.
8.2 Monitoring: Centralized and Onsite
Designing proportionate monitoring strategies, including centralized and onsite activities.
8.3 Risk Assessment and Mitigation
Identifying, assessing, and mitigating risks, with ongoing review and CAPA where needed.
3 lessons · 135 minutes
9.1 Essential Documents and the TMF
Organizing and maintaining essential documents in the TMF to reconstruct trials.
9.2 Inspection Readiness and Noncompliance
Preparing for inspections, addressing noncompliance, and driving effective CAPA.
9.3 Study Completion and Reporting
Provide all required reports to sponsor; submit final report/summary to IRB/IEC and regulators as required (E6(R3) 2.13).
Create your free account, unlock the full curriculum, and download your certificate the moment you finish.
No credit card · Verified credential · Progress saves automatically