Good clinical practice (GCP)

Internationally agreed ethical and scientific quality standards for designing, conducting, recording, and reporting studies that involve human participants.

Adherence to Good Clinical Practice ensures that the rights, safety, and wellbeing of participants are respected and protected, and that clinical trial data are reliable. Compliance with Good Clinical Practice is generally a legal obligation for all studies of investigational medical products involving human participants.

Guideline for good clinical practice E6(R2) (EMA, 2016)

Handbook for good clinical research practice (GCP) (WHO, 2002)

ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline (Good Clinical Practice Network, 2021)