Good Clinical Practice Guidelines
GPTKB entity
Statements (49)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
regulatory standard |
| gptkbp:abbreviation |
gptkb:GCP
|
| gptkbp:appliesTo |
clinical trials
biological product trials medical device trials pharmaceutical product trials |
| gptkbp:basisFor |
audits
clinical trial approval regulatory inspections |
| gptkbp:category |
clinical research regulation
medical research ethics |
| gptkbp:covers |
quality assurance
informed consent confidentiality data integrity monitoring investigator responsibilities safety reporting sponsor responsibilities |
| gptkbp:enforcedBy |
gptkb:institutional_review_boards
ethics committees national regulatory agencies |
| gptkbp:firstPublished |
1996
|
| https://www.w3.org/2000/01/rdf-schema#label |
Good Clinical Practice Guidelines
|
| gptkbp:language |
English
multiple languages |
| gptkbp:publishedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:purpose |
ensure ethical and scientific quality of clinical trials
|
| gptkbp:recognizedBy |
gptkb:World_Health_Organization
gptkb:European_Medicines_Agency gptkb:U.S._Food_and_Drug_Administration gptkb:Pharmaceutical_and_Medical_Devices_Agency_(Japan) |
| gptkbp:relatedTo |
gptkb:ICH_E6(R2)
gptkb:Declaration_of_Helsinki human subject protection |
| gptkbp:requires |
gptkb:legislation
manual protocol adherence data accuracy investigator training sponsor oversight subject safety monitoring |
| gptkbp:updated |
2016
|
| gptkbp:usedBy |
pharmaceutical industry
regulatory authorities clinical researchers |
| gptkbp:bfsParent |
gptkb:Medical_Research
|
| gptkbp:bfsLayer |
6
|