Principles of Good Clinical Practice

Good Clinical Practice (GCP) is an international ethical, scientific and quality standard for clinical trials involving human participants. It provides assurance that participants’ rights, safety and well-being are protected and that clinical trial data and reported results are reliable.

The current ICH E6(R3) Good Clinical Practice framework emphasizes participant protection, reliable trial results, quality by design, proportionality to risk and the use of appropriate processes and systems throughout the clinical trial.

The current framework is described in the ICH E6 Good Clinical Practice guideline.

For more information about the organization responsible for harmonizing GCP and other pharmaceutical guidelines, see the International Council for Harmonisation (ICH).

Rights, Safety and Well-being of Participants

The rights, safety and well-being of trial participants are fundamental considerations in clinical research.

Clinical trials should be conducted in accordance with ethical principles originating in the Declaration of Helsinki and consistent with GCP and applicable regulatory requirements.

Foreseeable risks and inconveniences should be considered in relation to the anticipated benefits for individual participants and society.

Informed Consent

Informed consent is an essential part of protecting the autonomy of clinical trial participants.

Participants should receive relevant information in a clear and understandable manner and have an appropriate opportunity to consider participation and ask questions.

Consent should be obtained and documented before participation in the trial, in accordance with applicable requirements.

Independent Ethical Review

Clinical trials should undergo independent review by an Institutional Review Board or Independent Ethics Committee (IRB/IEC).

The IRB/IEC evaluates relevant ethical aspects of the trial, including participant protection, informed consent materials and other information provided to participants.

Appropriate approval or favourable opinion should be obtained before the trial begins.

Scientifically Sound Clinical Trials

Clinical trials should be scientifically sound and based on adequate knowledge of the investigational product and the condition being studied.

The trial protocol should clearly describe the objectives, design, methodology, statistical considerations and organisation of the trial.

A scientifically inadequate trial may expose participants to risks without producing reliable or meaningful knowledge.

Qualified Individuals

Clinical trial activities should be performed by individuals who are appropriately qualified through education, training and experience for their assigned responsibilities.

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