{"product_id":"ich-e6r3-kit-04-trial-design-protocol","title":"E6(R3) Sponsor Kit 04 — Trial Design \u0026 Protocol","description":"\u003cp\u003eWriting a protocol that can be run, and amending it without losing track of who approved what.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e2 procedures, 8 records.\u003c\/strong\u003e Four of its expectations are new in R3, including the one people trip over: a system change arising from an amendment reaches a site only once \u003cem\u003ethat site's\u003c\/em\u003e approvals are in place (4.3.5).\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eProtocol development, with the cross-functional review record\u003c\/li\u003e\n\u003cli\u003eProtocol amendments, impact assessment and site-by-site approval tracking\u003c\/li\u003e\n\u003cli\u003eDesign considerations tied back to critical-to-quality factors\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003ePairs well with Kit 01, which is where the critical-to-quality worksheet lives.\u003c\/p\u003e\n\u003cp\u003eWord and Excel, editable, no macros. Individual Licence. \u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47734527230123,"sku":"KA-TK-E6R3-K04","price":1045.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-kit-04-trial-design-protocol.jpg?v=1788306905","url":"https:\/\/www.kaclinical.com\/products\/ich-e6r3-kit-04-trial-design-protocol","provider":"KA Clinical","version":"1.0","type":"link"}