{"version":"1.0","type":"card","id":"d0afe030-d96d-4afc-a9c8-a3f79dd63abb","url":"https://stacklist.com/card/d0afe030-d96d-4afc-a9c8-a3f79dd63abb","title":"ICH GCP E6 (R3) Good Clinical Practice Guidelines","source_url":"https://www.florencehc.com/florence-ich-gcp-e6-r3-compliance/","note":"ICH GCP E6 R3 guidelines outlining the significant implications for clinical trial sponsor and site technology and document management.","image":{"url":"https://ucarecdn.com/207a4945-e640-4de6-8c21-c02a659a4071/","alt":"ICH GCP E6 (R3) Good Clinical Practice Guidelines","width":1400,"height":1400},"stack":{"id":"9abd6cca-e98c-4b42-be2a-905514c66396","title":"Essential Information","url":"https://stacklist.com/stack/9abd6cca-e98c-4b42-be2a-905514c66396"},"created_at":"2026-07-02T07:54:34.686Z","updated_at":null,"aco":{"summary":"Florence ICH GCP E6(R3) Compliance Overview explains the new regulatory framework finalized on January 6, 2025, emphasizing sponsor-site partnership, decentralized trials, and technology-enabled collaboration. The document outlines key sponsor responsibilities including quality by design, remote oversight, transparent collaboration, and digital system management, while detailing site expectations for document control, inspection readiness, and continuous quality improvement.","tags":["ich-gcp-e6r3","clinical-trials","compliance","sponsor-site-partnership","digital-systems","quality-by-design","regulatory"],"key_entities":[{"name":"International Council for Harmonisation (ICH)","type":"organization","confidence":0.99},{"name":"Florence","type":"organization","confidence":0.95},{"name":"Florence SiteLink®","type":"technology","confidence":0.99},{"name":"ICH E6(R3)","type":"concept","confidence":0.99},{"name":"Good Clinical Practice (GCP)","type":"concept","confidence":0.98},{"name":"Quality by Design","type":"concept","confidence":0.95},{"name":"decentralized trials","type":"concept","confidence":0.92},{"name":"ICH E6(R3) finalization on January 6, 2025","type":"event","confidence":0.98}],"classification":"reference","language":"en","confidence":0.85,"provenance":{"model":"claude-haiku-4-5","tool":"@stacklist/be@0.1.0","confidence":0.85,"timestamp":"2026-07-02T07:54:41.146Z"},"token_counts":{"approximate":1495,"cl100k":1207},"content_hash":"sha256:62906559f0a68e4c119ca11ca37daa50c9dc12d6dcfe083064e46328fdd134e7","acp_version":"0.2","body_available":true,"body_tokens":1495,"visibility":"public","agent_accessible":true,"status":"final"},"_links":{"self":"/api/public/card/d0afe030-d96d-4afc-a9c8-a3f79dd63abb.json","html":"https://stacklist.com/card/d0afe030-d96d-4afc-a9c8-a3f79dd63abb","md":"/api/public/card/d0afe030-d96d-4afc-a9c8-a3f79dd63abb.md","stack_json":"/api/public/stack/9abd6cca-e98c-4b42-be2a-905514c66396.json"}}