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gptkbp:instanceOf
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gptkb:Tourism
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gptkbp:abbreviation
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gptkb:International_Council_for_Harmonisation_-_Good_Clinical_Practice
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gptkbp:appliesTo
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clinical research
pharmaceutical research
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gptkbp:basisFor
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regulatory requirements for clinical trials
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gptkbp:category
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gptkb:medical_guideline
clinical research regulation
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gptkbp:firstPublished
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1996
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gptkbp:focusesOn
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clinical trials
good clinical practice
|
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gptkbp:fullName
|
gptkb:International_Council_for_Harmonisation_-_Good_Clinical_Practice
|
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gptkbp:includes
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guidance on ethics committee
guidance on informed consent
guidance on investigator responsibilities
guidance on monitoring
guidance on record keeping
guidance on reporting
guidance on sponsor responsibilities
guidance on trial protocol
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gptkbp:latestReleaseVersion
|
gptkb:E6(R2)
2016
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gptkbp:publishedBy
|
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
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gptkbp:purpose
|
to ensure credibility of clinical trial data
to ensure the safety, rights, and well-being of clinical trial subjects
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gptkbp:usedIn
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gptkb:Europe
gptkb:Japan
gptkb:United_States
many other countries
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gptkbp:bfsParent
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gptkb:eConsent
gptkb:Medidata_Rave
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gptkbp:bfsLayer
|
8
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|
https://www.w3.org/2000/01/rdf-schema#label
|
ICH-GCP
|