ICH E6(R3) - Good Clinical Practice

What it says

Good Clinical Practice establishes ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials involving human subjects, with the 2023 revision introducing a more explicit risk-based, proportionate approach to quality management throughout the trial lifecycle.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The R3 revision shifts emphasis toward a risk-based quality management approach applied throughout trial design and conduct, rather than uniform, maximal oversight applied identically regardless of a specific trial's actual risk profile.
• This guideline governs the clinical trial process itself, data collection, informed consent, investigator responsibilities and trial oversight, operating alongside but distinct from the GMP requirements governing manufacture of the investigational product under EU GMP Annex 13.
• Quality by design principles, familiar from ICH Q8(R2) in the manufacturing context, appear in a parallel form here, encouraging trial design that builds in quality and risk mitigation from the outset rather than relying solely on downstream monitoring to catch problems.

What inspectors look for

• Whether a trial's quality management approach is genuinely risk-based and proportionate to the specific trial's actual risk factors, rather than defaulting to one-size-fits-all oversight regardless of risk.
• Whether critical-to-quality factors specific to the trial were identified during design and are actually monitored throughout conduct.
• Whether data integrity and informed consent documentation meet the same fundamental reliability principles expected of GMP records generally.

Related regulations