ICH E6 Good Clinical Practice
GPTKB entity
Statements (30)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:abbreviation |
ICH E6 GCP
|
| gptkbp:appliesTo |
pharmaceutical clinical trials
|
| gptkbp:firstPublished |
1996
|
| gptkbp:hasSection |
gptkb:Ethics
quality assurance record keeping informed consent monitoring investigator responsibilities sponsor responsibilities trial protocol data handling |
| https://www.w3.org/2000/01/rdf-schema#label |
ICH E6 Good Clinical Practice
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:language |
English
|
| gptkbp:latestReleaseVersion |
gptkb:ICH_E6(R3)
2023 |
| gptkbp:purpose |
to ensure credibility of clinical trial data
to ensure the safety, rights, and well-being of trial subjects |
| gptkbp:relatedTo |
gptkb:EMA_guidelines
FDA regulations ICH guidelines |
| gptkbp:status |
active
|
| gptkbp:subject |
clinical trials
good clinical practice |
| gptkbp:usedBy |
regulatory authorities worldwide
|
| gptkbp:website |
https://www.ich.org
|
| gptkbp:bfsParent |
gptkb:ICH
|
| gptkbp:bfsLayer |
6
|