The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants.
This guideline provides recommendations for harmonised approaches for paediatric extrapolation to support the development and authorisation of paediatric medicines.
GuidelineE.4: Atmospheric Protection Intent To select refrigerants that reduce environmental impacts, including harm to the environment, risk to human health, and ozone depletion potential.
GuidelineE.2: Renewable Energy Intent To facilitate the implementation of onsite renewable energy and promote the development of offsite renewable generation to satisfy project energy demand.
GuidelineE.1: Energy Efficiency Intent To establish and meet the building energy and carbon performance standard in design and operation in order to significantly reduce carbon dioxide emissions and lower energy use.
The E9(R1) addendum aims to clarify and extend ICH E9 by elaborating on the choice of estimand and sensitivity analysis in clinical trials, providing a framework to align its planning, design, conduct, analysis and interpretation.