The ICH guideline 'General considerations for clinical studies' is intended to describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities, provide guidance on the consideration of quality in the design and conduct of ...

ICH E8 provides an overall introduction to clinical development, designing quality into clinical studies and focusing on those factors critical to the quality of the studies.

Oct 6, 2021 · ICH E8 (R1) provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used. This modernisation of ICH E8 is the first step towards the Renovation of Good Clinical Practice initiated in 2017.

This version of the ICH E8 General Considerations for Clinical Studies Guideline was finalised in October 2021 and sets out general principles on the conduct of clinical studies, with the objectives of the document being to: (1) Describe internationally accepted principles and practices in the design and conduct of clinical studies that will ...

present an overview of the ICH clinical safety and efficacy documents and facilitate the user's access to guidance pertinent to clinical trials within these documents. The relevant ICH documents are listed in Annex 1.

Dec 11, 2024 · ICH E8 (R1): General Considerations for Clinical Studies. This guidance describes internationally accepted principles and practices in the design and conduct of clinical studies of drug...

Oct 24, 2024 · The ICH Secretariat is pleased to announce the publication of ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video. The video is available for download and can be found in the ICH Training Library.

Change management will be a key to implementation of E8 (and E6) revision. health policy decisions. This document focuses on designing quality into clinical studies, considering the diversity of clinical study designs and data sources used to support regulatory and other health policy decisions.

The Food and Drug Administration (FDA) is announcing a public meeting organised by the International Council for Harmonisation (ICH) and entitled “ICH Global Meeting on E8 (R1) Guideline on...

The ICH document "General Considerations for Clinical Studies" is intended to: 1. Describe internationally accepted principles and practices in the design and conduct of clinical studies that will ensure the protection of study participants and facilitate acceptance of data and results by regulatory authorities.