International Council for Harmonisation - Good Clinical Practice
GPTKB entity
Statements (27)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:abbreviation |
gptkb:ICH-GCP
|
| gptkbp:appliesTo |
clinical research
pharmaceutical industry |
| gptkbp:basisFor |
regulatory requirements in US, EU, Japan
|
| gptkbp:category |
medical guideline
|
| gptkbp:developedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:firstPublished |
1996
|
| gptkbp:focusesOn |
clinical trials
human subjects |
| gptkbp:hasVersion |
gptkb:E6(R2)
E6(R3) |
| https://www.w3.org/2000/01/rdf-schema#label |
International Council for Harmonisation - Good Clinical Practice
|
| gptkbp:includes |
informed consent
confidentiality data integrity protocol adherence |
| gptkbp:language |
English
|
| gptkbp:purpose |
ensure ethical and scientific quality of clinical trials
|
| gptkbp:relatedTo |
gptkb:Declaration_of_Helsinki
World Health Organization guidelines |
| gptkbp:usedBy |
ethics committees
regulatory authorities sponsors clinical investigators |
| gptkbp:bfsParent |
gptkb:ICH-GCP
|
| gptkbp:bfsLayer |
7
|