Report of Unanticipated and Serious Adverse Events Clause Samples

Report of Unanticipated and Serious Adverse Events. Principal Investigator shall notify Sponsor of any (i) serious adverse events which occur to Subjects and (ii) unanticipated problems involving risks to Subjects or others, all in accordance with
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Report of Unanticipated and Serious Adverse Events. Principal Investigator shall notify Sponsor of any (i) serious adverse events which occur to Subjects and (ii) unanticipated problems involving risks to Subjects or others, all in accordance with (x) the Protocol, (y) any Sponsor guidelines with respect thereto as Sponsor may from time to time supply to Site, and (z) requirements of applicable Law. (g) Subject Safety. As required by 21 C.F.R. 50 potřebné pro efektivní a operativní plnění povinností podle této smlouvy. (c) Úpravy protokolu a souvisejících dokumentů. Centrum ani HZ nesmějí provádět žádné změny či revize protokolu nebo informovaného souhlasu, pokud (i) nebyly nejprve písemně schváleny zadavatelem a hlavním zkoušejícím a prověřeny a schváleny příslušnou etickou komisí (ethics committee, ▇▇▇▇ ▇▇▇ „EK“), nebo (ii) je hlavní zkoušející nepovažuje za potřebné v souladu s obecně přijatými normami správné klinické praxe z hlediska ochrany bezpečnosti, práv nebo prospěchu subjektů, kdy v takovém případě zadavatel a EK musí být o příslušné změně neprodleně informováni, a to písemně. Požaduje-li ▇▇ ▇▇▇▇▇▇ změny v protokolu nebo informovaném souhlasu, zadavatel musí být informován předem a veškeré úpravy protokolu a informovaného souhlasu musejí být předem písemně schváleny zadavatelem.
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Related to Report of Unanticipated and Serious Adverse Events

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.