ICH E6(R3)

URI: https://gptkb.org/entity/ICH_E6(R3)
GPTKB entity
Statements (24)
Predicate Object
gptkbp:instanceOf gptkb:Tourism
gptkbp:abbreviation gptkb:ICH_E6(R3)
gptkbp:aimsTo ensure credibility of clinical trial data
ensure ethical and scientific quality in clinical trials
protect rights, safety, and well-being of trial subjects
gptkbp:announced 2021
gptkbp:appliesTo clinical trials
pharmaceutical development
gptkbp:dateDraftReleased 2023
gptkbp:focusesOn gptkb:Good_Clinical_Practice
gptkbp:fullName International Council for Harmonisation Guideline for Good Clinical Practice E6(R3)
gptkbp:language English
gptkbp:partOf ICH E6 guidelines
gptkbp:publishedBy gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
gptkbp:region global
gptkbp:replacedBy gptkb:ICH_E6(R2)
gptkbp:status draft (as of 2024)
gptkbp:targetAudience investigators
regulatory authorities
sponsors
gptkbp:bfsParent gptkb:Good_Clinical_Practice
gptkb:ICH_E6_Good_Clinical_Practice
gptkbp:bfsLayer 7
https://www.w3.org/2000/01/rdf-schema#label ICH E6(R3)