Good Clinical Practice guidance

URI: https://gptkb.org/entity/Good_Clinical_Practice_guidance
GPTKB entity
Statements (25)
Predicate Object
gptkbp:instanceOf gptkb:Tourism
gptkbp:abbreviation gptkb:GCP
gptkbp:appliesTo clinical trials involving human subjects
gptkbp:basisFor regulatory requirements for clinical trials
gptkbp:field clinical research
gptkbp:firstPublished 1996
gptkbp:includes protection of human rights
ensuring data integrity
investigator responsibilities
sponsor responsibilities
requirements for informed consent
requirements for ethics committee review
gptkbp:language English
multiple languages
gptkbp:publishedBy gptkb:World_Health_Organization
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
gptkb:U.S._Food_and_Drug_Administration
gptkbp:purpose ensure ethical and scientific quality of clinical trials
gptkbp:region global
gptkbp:relatedTo gptkb:Declaration_of_Helsinki
gptkb:clinical_trial_protocol
ICH E6 guideline
gptkbp:bfsParent gptkb:FDA_guidance
gptkbp:bfsLayer 7
https://www.w3.org/2000/01/rdf-schema#label Good Clinical Practice guidance