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Z\u00c1ZNAMY, V\u00ddKAZY, P\u0158\u00cdSTUP\n(a) Zmocn\u011bn\u00ed z\u00e1stupci Zadavatele, p\u0159\u00edpadn\u011b jeho pov\u011b\u0159en\u00fdmi studijn\u00edmi monitory, jsou opr\u00e1vn\u011bni na z\u00e1klad\u011b p\u0159im\u011b\u0159en\u00e9ho p\u0159edchoz\u00edho ozn\u00e1men\u00ed v p\u0159im\u011b\u0159en\u00e9 lh\u016ft\u011b a b\u011bhem obvykl\u00e9 pracovn\u00ed \u2587\u2587\u2587\u2587: (i) prov\u00e1d\u011bt audit a prov\u011b\u0159it vybaven\u00ed \u0159e\u0161itelsk\u00e9ho centra pot\u0159ebn\u00e9 k proveden\u00ed studie; a (ii) zkontrolovat a vytvo\u0159it si kopie ve\u0161ker\u00fdch \u00fadaj\u016f, z\u00e1znam\u016f a v\u00fdsledk\u016f pr\u00e1ce souvisej\u00edc\u00edch s prov\u00e1d\u011bn\u00edm studie, a jestli\u017ee to je pot\u0159ebn\u00e9, po\u0159izovat si kopie takov\u00fdch \u00fadaj\u016f, z\u00e1znam\u016f a v\u00fdsledk\u016f pr\u00e1ce, za p\u0159edpokladu, \u017ee takov\u00e9 kopie neobsahuj\u00ed nepovolen\u00e9 individu\u00e1ln\u011b identifikovateln\u00e9 informace o subjektu studie. \u0158e\u0161itelsk\u00e9 centrum je povinno v\u00e9st \u00fapln\u00e9 a spr\u00e1vn\u00e9 z\u00e1znamy t\u00fdkaj\u00edc\u00ed se studie, a z\u00e1znamy vznikl\u00e9 ze \u2587\u2587\u2587\u2587\u2587\u2587 \u2587\u2587 povinno archivovat v souladu s ICH GCP po dobu, jakou stanov\u00ed p\u0159\u00edslu\u0161n\u00e9 z\u00e1kony a pr\u00e1vn\u00ed p\u0159edpisy.\n(a) The Investigator will deliver CRFs to PRA within fourteen (14) days of Investigator\u2019s review or in accordance with PRA\u2019s reasonable written instructions, as the case may be. Site will ensure that its Study Team members assist Sponsor in resolving any queries regarding discrepancies or missing information in CRFs. The Investigator shall be available at reasonable times during normal business hours to meet with Study monitors and answer questions regarding the conduct of the Study. If PRA or Sponsor or its designees must perform check of data against data in the Site\u2019s computer systems with medical data, they will do so in accordance with the Site\u2019s instructions and only under supervision of some of the study personel and will only use acquired information for the purpose of the Study and in accordance with applicable laws. PRA or Sponsor or its designees will not have (b) Zkou\u0161ej\u00edc\u00ed vypln\u00ed a za\u0161le z\u00e1znamy e-CRF spole\u010dnosti PRA do \u010dtrn\u00e1cti (14) pracovn\u00edch dn\u00ed od p\u0159\u00edslu\u0161n\u00e9 n\u00e1v\u0161t\u011bvy a revize zkou\u0161ej\u00edc\u00edho nebo v souladu s p\u0159im\u011b\u0159en\u00fdmi p\u00edsemn\u00fdmi pokyny PRA podle okolnost\u00ed. \u0158e\u0161itelsk\u00e9 centrum zajist\u00ed, \u017ee \u010dlenov\u00e9 studijn\u00edho t\u00fdmu pomohou Zadavateli \u0159e\u0161it jak\u00e9koli dotazy t\u00fdkaj\u00edc\u00ed se nesrovnalost\u00ed nebo chyb\u011bj\u00edc\u00edch \u00fadaj\u016f v CRF. Zkou\u0161ej\u00edc\u00ed bude v p\u0159im\u011b\u0159en\u00fdch hodin\u00e1ch v b\u011b\u017en\u00e9 pracovn\u00ed dob\u011b k dispozici ke sch\u016fzk\u00e1m s monitory studie a odpov\u00eddat na jejich ot\u00e1zky t\u00fdkaj\u00edc\u00ed se prov\u00e1d\u011bn\u00ed studie. Pokud mus\u00ed PRA nebo Zadavatel nebo jeho z\u00e1stupci prov\u00e9st kontrolu dat s daty v elektronick\u00e9m syst\u00e9mu l\u00e9ka\u0159sk\u00fdch z\u00e1znam\u016f \u0159e\u0161itelsk\u00e9ho centra, u\u010din\u00ed tak v souladu s pokyny \u0159e\u0161itelsk\u00e9ho centra a pouze za dohledu n\u011bkter\u00e9ho z \u010dlen\u016f studijn\u00edho t\u00fdmu, kdy z\u00edskan\u00e9 informace pou\u017eije pouze pro \u00fa\u010dely studie a v souladu s p\u0159\u00edslu\u0161n\u00fdmi pr\u00e1vn\u00edmi p\u0159edpisy. PRA nebo Zadavatel nebo jeho direct access to the Site\u2019s computer systems with medical data. z\u00e1stupci nebudou m\u00edt p\u0159\u00edm\u00fd p\u0159\u00edstup do elektronick\u00e9ho syst\u00e9mu l\u00e9ka\u0159sk\u00fdch z\u00e1znam\u016f \u0159e\u0161itelsk\u00e9ho centra.\n(b) The Site will promptly notify Sponsor and PRA if any regulatory authority notifies the Provider of healthcare services or Investigator of a pending inspection relating to the Study, and will promptly forward to Sponsor and PRA copies of any written communication received as a result of such inspection which are related to the Study. The Site shall also provide to Sponsor and PRA copies of any documents provided to any inspector that relate to the Study.\n(c) \u0158e\u0161itelsk\u00e9 centrum bude bezodkladn\u011b informovat Zadavatele a PRA, jestli\u017ee bude n\u011bjak\u00fd regula\u010dn\u00ed \u00fa\u0159ad informovat Poskytovatele zdravotn\u00edch slu\u017eeb nebo Zkou\u0161ej\u00edc\u00edho o chystan\u00e9 kontrole nebo auditu t\u00fdkaj\u00edc\u00edho se studie, a bezodkladn\u011b postoup\u00ed Zadavateli a PRA kopie ve\u0161ker\u00fdch p\u00edsemn\u00fdch materi\u00e1l\u016f, kter\u00e9 obdr\u017e\u00ed v souvislosti s touto kontrolou, a kter\u00e9 souvisej\u00ed se studi\u00ed. \u0158e\u0161itelsk\u00e9 centrum \u2587\u2587 \u2587\u2587\u2587\u2587 povinno p\u0159edat Zadavateli a PRA kopie ve\u0161ker\u00fdch dokument\u016f, kter\u00e9 poskytlo kontrolor\u016fm, a kter\u00e9 se vztahuj\u00ed ke studii.", "hash": "f7099e0afb4ead2f17ab37c93253b322", "id": 10}], "next_curs": "CmASWmoVc35sYXdpbnNpZGVyY29udHJhY3RzcjwLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IiByZWNvcmRrZWVwaW5nLXJlcG9ydGluZyMwMDAwMDAwYQyiAQJlbhgAIAA=", "clause": {"size": 41, "title": "Recordkeeping / Reporting", "parents": [["health-care-matters", "Health Care Matters"], ["representations-and-warranties", "REPRESENTATIONS AND WARRANTIES"], ["accounting-and-other-terms", "ACCOUNTING AND OTHER TERMS"], ["whereas", "WHEREAS"], ["general-release", "General Release"]], "children": [["audit", "Audit"], ["commercial-invoice", "Commercial Invoice"], ["documentation-requirements", "Documentation Requirements"], ["country-of-origin", "Country of Origin"], ["records", "Records"]], "id": "recordkeeping-reporting", "related": [["recordkeeping-requirements", "Recordkeeping Requirements", "Recordkeeping Requirements"], ["recordkeeping", "Recordkeeping", "Recordkeeping"], ["reporting-and-recordkeeping", "Reporting and Recordkeeping", "Reporting and Recordkeeping"], ["recordkeeping-and-reporting", "Recordkeeping and Reporting", "Recordkeeping and Reporting"], ["record-keeping-requirements", "Record Keeping Requirements", "Record Keeping Requirements"]], "related_snippets": [], "updated": "2026-05-15T04:24:17+00:00", "also_ask": [], "drafting_tip": null, "explanation": "The Recordkeeping / Reporting clause requires parties to maintain accurate and complete records related to their activities under the agreement and to provide reports as specified. Typically, this involves keeping documentation such as financial statements, transaction logs, or compliance records, and submitting periodic reports to the other party or a regulatory body. The core function of this clause is to ensure transparency and accountability, enabling parties to verify compliance and resolve disputes by referencing reliable records."}, "json": true, "cursor": ""}}