|
gptkbp:instanceOf
|
Tourism
|
|
gptkbp:abbreviation
|
gptkb:GCP
|
|
gptkbp:adoptedBy
|
gptkb:Australia
gptkb:Canada
gptkb:China
gptkb:European_Union
gptkb:India
gptkb:Japan
gptkb:United_States
|
|
gptkbp:appliesTo
|
clinical trials involving human subjects
|
|
gptkbp:basisFor
|
regulatory approval of new drugs
|
|
gptkbp:component
|
ICH guidelines
|
|
gptkbp:field
|
clinical research
|
|
gptkbp:firstPublished
|
1996
|
|
gptkbp:focusesOn
|
protection of human rights
integrity of clinical trial data
|
|
gptkbp:hasVersion
|
gptkb:ICH_E6(R2)
gptkb:ICH_E6(R3)
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Good Clinical Practice
|
|
gptkbp:includes
|
record keeping
informed consent
reporting
monitoring
protocol adherence
|
|
gptkbp:language
|
English
multiple languages
|
|
gptkbp:publishedBy
|
gptkb:World_Health_Organization
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
|
gptkbp:purpose
|
ensure ethical and scientific quality of clinical trials
|
|
gptkbp:region
|
global
|
|
gptkbp:relatedTo
|
gptkb:Belmont_Report
gptkb:Declaration_of_Helsinki
clinical trial regulation
|
|
gptkbp:bfsParent
|
gptkb:Good_Laboratory_Practice
gptkb:Clinical_Research_Associate
|
|
gptkbp:bfsLayer
|
6
|