February 23, 2026
Good Clinical Practice (GCP) represents the international ethical and scientific standard for designing, conducting, and reporting clinical trials. While ICH E6(R2) contained 13 principles, the updated ICH E6(R3) guidance outlines 11 refined principles that broaden the guideline’s applicability and promote modern, flexible approaches to ensure participant protection and research quality.
As part of our Preparing for ICH E6(R3) series, this article walks through the 11 principles of GCP.
Principle 1
Ethical Conduct
Clinical trials must follow ethical principles rooted in the Declaration of Helsinki. These principles ensure that participant rights, safety, and well-being take precedence over scientific or societal interests.
The Declaration of Helsinki is a statement that was initially developed and adopted by the World Medical Association (WMA), an international organization created to ensure the independence of physicians, and to work for the highest possible standards of ethical behaviour and care by physicians in June of 1964.
The declaration is described as a “statement of ethical principles for medical research involving human participants, including research using identifiable human material or data.”
The WMA states that, “While the Declaration is adopted by physicians, the WMA holds that these principles are fundamental to respect for and protection of research participants and should be upheld by all parties involved in medical research.” It is widely regarded as a cornerstone document on human research.
Principle 2
Informed Consent
Trial participation must be voluntary and based on a clear, comprehensive, and well-documented consent process. Consent must be obtained before trial participation, with special provisions for minors and emergency situations.
Principle 3
Independent Review
All clinical trials must undergo review and approval by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC), with ongoing oversight as required.
Principle 4
Scientific Soundness
Trials must be grounded in solid scientific evidence and current knowledge. A periodic review of current scientific knowledge and approaches should occur to ensure continued relevance and safety.
Principle 5
Qualified Individuals
Clinical research requires individuals with different expertise and training (e.g., physicians, technology experts, trial coordinators, auditors, etc.). All trials should be designed and conducted by individuals with proper education, training, and experience to perform their tasks.
Principle 6
Quality by Design
Quality should be built into trial design and operations. Identify Critical to Quality (CtQ) factors upfront and implement strategies to prevent serious noncompliance.
ICH E8(R1) states “the quality by design approach to clinical research involves focusing on critical to quality factors to ensure the protecting of the rights, safety, and wellbeing of study participants, the generation of reliable and meaningful results, and the management of risks to those factors using a risk proportionate approach.”
It goes on to speak on what goes into good planning and implementation for a study, as well as a description of critical to quality factors (“attributes of a study whose integrity is fundamental to the protection of study participants, the reliability and interpretability of the study results, and the decision made based on the study results”) and expectations surrounding those factors.
Principle 7
Risk-Proportionate Processes
Processes should be proportionate to participant risk and data importance, avoiding unnecessary complexity or burden.
Principle 8
Clear and Feasible Protocol
Trials must have a clear, concise, scientifically sound, and operationally feasible protocol, including supporting plans (e.g., statistical analysis plan, monitoring plan).
Principle 9
Reliable Results
Systems and processes should ensure data integrity, traceability, and confidentiality. Trials should generate sufficient, fit-for-purpose data to support decision making.
Principle 10
Defined Roles and Responsibilities
Roles and responsibilities of sponsors, investigators, and service providers must be clearly documented even when tasks are delegated.
While a sponsor or investigator may delegate tasks, duties or activities, they retain overall responsibility for trial conduct, including quality and integrity of the trial data.
Principle 11
Investigational Product Management
Investigational products must comply with Good Manufacturing Practice (GMP), maintain quality throughout handling, and be managed per protocol and regulatory requirements.
Conclusion
The 11 principles outlined in ICH e6(R3) reinforce the ethical, scientific, and operational foundations essential to conducting high quality clinical research.
PharPoint Research is a collaborative contract research organization (CRO) that can support sponsors as they implement ICH E6(R3). Our quality assurance team can offer comprehensive hands-on training programs tailored to their organizational needs, ensuring teams understand the updated guidance and how to apply to in their day-to-day roles.
For organizations seeking deeper support, our experienced QA consultants can perform full organizational assessments to evaluate current processes, identify potential gaps, and develop compliant, adoptable solutions that strengthen GCP alignment across the entire organization.
For more information, reach out to our team.
Supporting Sources
ICH E6 R3: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
ICH e8 R1: https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf
World Medical Association: https://www.wma.net/policies-post/wma-declaration-of-helsinki/
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