{"product_id":"ich-e6r3-kit-07-safety-medical-oversight","title":"E6(R3) Sponsor Kit 07 — Safety \u0026 Medical Oversight","description":"\u003cp\u003eThe Investigator's Brochure, safety reporting, and having a doctor actually reachable.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e3 procedures, 17 records.\u003c\/strong\u003e R3 expects medical personnel readily available to advise on trial-related medical questions (3.4.1) — which means named people and a documented arrangement, not a good intention.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eInvestigator's Brochure and reference safety information, with the annual update record\u003c\/li\u003e\n\u003cli\u003eSafety reporting and immediate hazards, including expedited reporting decisions\u003c\/li\u003e\n\u003cli\u003eMedical monitoring and committees: charters, minutes, escalation\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eSeven expectations here are scored Critical. If you have no written medical cover arrangement, this is the kit that closes it.\u003c\/p\u003e\n\u003cp\u003eWord and Excel, editable, no macros. Individual Licence. These are templates, not an approved quality system.\u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47734538436779,"sku":"KA-TK-E6R3-K07","price":1295.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-kit-07-safety-medical-oversight.jpg?v=1788306532","url":"https:\/\/www.kaclinical.com\/products\/ich-e6r3-kit-07-safety-medical-oversight","provider":"KA Clinical","version":"1.0","type":"link"}