{"title":"Monitoring \u0026 Risk","description":"\u003cp\u003eRisk-based oversight that regulators recognize: monitoring plans, critical-to-quality frameworks, action-item trackers.\u003c\/p\u003e","products":[{"product_id":"ich-e6r3-kit-08-monitoring","title":"E6(R3) Sponsor Kit 08 — Monitoring","description":"\u003cp\u003eThe written case for monitoring less. A risk-based strategy, a data verification specification that states what gets verified and what does not, and the records that show you followed your own plan.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e1 procedure, 5 records\u003c\/strong\u003e — the kit with the most leverage per page.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eMonitoring strategy driven by critical-to-quality factors\u003c\/li\u003e\n\u003cli\u003eData verification specification — the document that defines less than 100% SDV\u003c\/li\u003e\n\u003cli\u003eMonitoring plan, visit and central monitoring reports, and output review\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eR3 offers \u003cem\u003erelief\u003c\/em\u003e on monitoring reports rather than new duty. That is exactly why this kit earns its place: monitoring is one of the largest controllable costs in trial conduct, and reduced source data verification is the recognised way to bring it down — but you cannot defend verifying less than everything without a written, risk-driven rationale. These are those documents. Three of its expectations are Critical.\u003c\/p\u003e\n\u003cp\u003eFeeds off the risk register in Kit 01, so buy that one first if you do not have it.\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":47734540140715,"sku":"KA-TK-E6R3-K08","price":795.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-kit-08-monitoring_e065f418-ba9b-4989-8fbe-14327081804d.jpg?v=1788308992"}],"url":"https:\/\/www.kaclinical.com\/collections\/monitoring-risk.oembed","provider":"KA Clinical","version":"1.0","type":"link"}