ICH E6 (Good Clinical Practice)
GPTKB entity
Statements (40)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:abbreviation |
ICH E6 (GCP)
|
| gptkbp:appliesTo |
gptkb:European_Union
gptkb:Japan gptkb:United_States pharmaceutical clinical trials other ICH member countries |
| gptkbp:category |
regulatory guideline
|
| gptkbp:covers |
manual
informed consent data integrity monitoring ethics committee review investigator responsibilities sponsor responsibilities protection of human subjects clinical trial conduct essential documents |
| gptkbp:firstPublished |
1996
|
| 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 |
R3 (in development as of 2023)
|
| gptkbp:purpose |
to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by regulatory authorities
|
| gptkbp:relatedTo |
ICH GCP
ICH E8 (General Considerations for Clinical Trials) |
| gptkbp:status |
active
|
| gptkbp:subject |
clinical trials
good clinical practice |
| gptkbp:updated |
2016 (R2)
|
| gptkbp:usedBy |
investigators
ethics committees pharmaceutical companies regulatory authorities clinical research organizations |
| gptkbp:website |
https://www.ich.org/page/efficacy-guidelines
|
| gptkbp:bfsParent |
gptkb:International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use
gptkb:ICH_Guidelines gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use_(ICH) |
| gptkbp:bfsLayer |
7
|