Good Clinical Practice guidance
GPTKB entity
Statements (25)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
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
|
| https://www.w3.org/2000/01/rdf-schema#label |
Good Clinical Practice guidance
|
| 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
clinical trial protocol ICH E6 guideline |
| gptkbp:bfsParent |
gptkb:FDA_guidance
|
| gptkbp:bfsLayer |
7
|