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Buy the one that hurts most; bundle when you're ready to fix the system.\u003c\/p\u003e","products":[{"product_id":"ich-e6r3-sponsor-suite-complete-set","title":"E6(R3) Sponsor Suite — Complete Set, all 11 kits","description":"\u003cp\u003eThe blank page is gone from every part of your sponsor quality system at once.\u003c\/p\u003e\n\u003cp\u003eAll eleven kits. \u003cstrong\u003e27 procedures and 122 distinct records\u003c\/strong\u003e covering the 157 sponsor expectations in the E6(R3) Principles and Annex 1, including all 32 that have no counterpart in E6(R2).\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eEvery form, log, register and Excel tool the procedures reference\u003c\/li\u003e\n\u003cli\u003eWorked examples of the trickier logs, so you can see one filled in\u003c\/li\u003e\n\u003cli\u003eThe suite-wide Transfer of Obligations and Oversight Matrix\u003c\/li\u003e\n\u003cli\u003eThe E6(R2) to E6(R3) change matrix\u003c\/li\u003e\n\u003cli\u003eA Read Me First in every kit, plus one for the suite\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eStart with the free gap assessment. 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Individual Licence.\u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47762106319019,"sku":"KA-TK-E6R3-SITE-K06","price":249.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-site-kit-06-investigational-product-blinding.jpg?v=1788798198"},{"product_id":"ich-e6r3-site-kit-07-safety-medical-oversight","title":"E6(R3) Site Kit 07 — Safety \u0026 Medical Oversight","description":"\u003cp\u003eParticipant medical care, safety assessment and getting adverse events reported on time.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e1 procedure, 5 records.\u003c\/strong\u003e Answers 10 site-facing E6(R3) expectations, 2 new in R3 and 4 scored critical — the densest critical ratio of any single-procedure kit in the suite.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eParticipant medical care, safety assessment and adverse event reporting\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eWord and Excel, editable, no macros. Individual Licence. 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Individual Licence.\u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47762108416171,"sku":"KA-TK-E6R3-SITE-K08","price":249.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-site-kit-08-samples-local-laboratory.jpg?v=1788798334"},{"product_id":"ich-e6r3-site-kit-09-data-source-records-systems","title":"E6(R3) Site Kit 09 — Data, Source Records \u0026 Systems","description":"\u003cp\u003eWhere E6(R3) changed most for sites, and where most sites have least written down.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e3 procedures, 15 records\u003c\/strong\u003e — answering 33 site-facing expectations, \u003cstrong\u003e26 of them entirely new in R3\u003c\/strong\u003e and 6 scored critical. 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Individual Licence.\u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47762110775467,"sku":"KA-TK-E6R3-SITE-K09","price":369.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-site-kit-09-data-source-records-systems.jpg?v=1788798470"},{"product_id":"ich-e6r3-site-kit-10-records-isf-inspection-readiness","title":"E6(R3) Site Kit 10 — Records, ISF \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, 10 records.\u003c\/strong\u003e Answers 24 site-facing E6(R3) expectations, 7 new in R3 and 6 scored critical.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eEssential records, the Investigator Site File and record retention\u003c\/li\u003e\n\u003cli\u003eMonitoring, audit and regulatory inspection readiness\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eOne of the quieter new expectations catches everybody: records reachable only through a sponsor's portal still have to end up with the party required to retain them.\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":47762112512171,"sku":"KA-TK-E6R3-SITE-K10","price":249.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-site-kit-10-records-isf-inspection-readiness.jpg?v=1788798546"},{"product_id":"ich-e6r3-site-kit-11-payments-close-out-continuity","title":"E6(R3) Site Kit 11 — Payments, Close-Out \u0026 Continuity","description":"\u003cp\u003ePaying participants without creating undue influence, shutting the site down properly, and having a plan for when something fails.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e3 procedures, 15 records.\u003c\/strong\u003e Answers 17 site-facing E6(R3) expectations, 9 new in R3 and 1 scored critical.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eParticipant reimbursement, payments and avoidance of undue influence\u003c\/li\u003e\n\u003cli\u003eEnd of participation, trial completion and site close-out\u003c\/li\u003e\n\u003cli\u003eContingency planning and business continuity for trial conduct\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eBusiness continuity is new ground for most sites. 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