{"product_id":"ich-e6r3-kit-10-records-tmf-inspection-readiness","title":"E6(R3) Sponsor Kit 10 — Records, TMF \u0026 Inspection Readiness","description":"\u003cp\u003eBeing able to find it, prove it was always there, and hand it over when someone asks.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e2 procedures, 9 records.\u003c\/strong\u003e Nine expectations here are scored Critical. One of the quieter new ones catches everybody: records reachable only through a portal still have to end up with the party required to retain them (C.2.8).\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eTrial Master File structure, completeness review and retention\u003c\/li\u003e\n\u003cli\u003eInspection readiness, including the mock inspection and findings log\u003c\/li\u003e\n\u003cli\u003eDirect access and inspection support records\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eIf your TMF lives partly in a vendor's system that you will lose access to at contract end, read that portal expectation first.\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":47734542827691,"sku":"KA-TK-E6R3-K10","price":1145.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-kit-10-records-tmf-inspection-readiness_7ee132ce-5c39-43da-9375-c0615fdc9da9.jpg?v=1788307212","url":"https:\/\/www.kaclinical.com\/products\/ich-e6r3-kit-10-records-tmf-inspection-readiness","provider":"KA Clinical","version":"1.0","type":"link"}