ICH E6(R3) - Good Clinical Practice P5: Have trials designed and conducted by individuals qualified by education, training and experience for each task

What does P5 require?

Many kinds of expertise may be needed across a trial, for example doctors, nurses, pharmacists, scientists, ethicists, technologists, coordinators, monitors, auditors and statisticians, and every person involved should have the education, training and experience for the tasks they carry out.

Maintained by Gerard BlokdykVerified against the published standard 31 May 2026Control text last updated 21 May 2026

Other controls in Introduction and the Principles of ICH GCP – ICH E6(R3) - Good Clinical Practice

P1 Run trials ethically under Declaration of Helsinki principles, GCP and the law, with participants' rights, safety and well-being placed above science and society, timely safety review, justified risk-benefit, representative populations, qualified medical responsibility and protected confidentiality
P10 Make roles and responsibilities clear and documented, keep overall responsibility when transferring or delegating activities, define them in agreements and oversee them
P11 Manufacture investigational products under applicable GMP, preserve their quality, use them per protocol, keep handling and labelling consistent with treatment assignment and blinding, label them as regulations require and control their full handling cycle
P2 Base participation on freely given, documented informed consent (or legally acceptable representative consent and minor assent) from a clear process suited to the trial, with deferred consent in emergencies as the IRB/IEC approves
P3 Submit the trial to independent IRB/IEC review, conduct it under the approved protocol and undergo periodic IRB/IEC review
P4 Make trials scientifically sound, supported by adequate nonclinical and clinical data and current knowledge, and review new scientific information periodically for needed modifications
P6 Build quality into trial design and conduct: treat quality as fitness for purpose, identify critical to quality factors prospectively, and prevent, detect and correct serious noncompliance
P7 Keep processes proportionate to risks to participants and the importance of the data, focus on risks beyond usual care, manage risks to critical factors proactively and avoid unnecessary complexity and burden

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All ICH E6(R3) - Good Clinical Practice controls