Adverse Events Sample Clauses
The Adverse Events clause defines the procedures and responsibilities related to the reporting, management, and documentation of any undesirable or unintended medical occurrences during a clinical trial or product use. Typically, this clause outlines the types of events that must be reported, the timelines for notification, and the parties responsible for monitoring and escalating such events. Its core function is to ensure patient safety and regulatory compliance by establishing clear protocols for handling adverse events, thereby minimizing risk and ensuring prompt response to potential safety issues.
POPULAR SAMPLE Copied 3 times
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.
Adverse Events. The Parties shall co-operate with regard to the reporting and handling of Adverse Events in accordance with the applicable regulatory laws and regulations on pharmacovigilance.
Adverse Events. The Investigator shall report adverse events and serious adverse events as directed in the Protocol and by applicable laws and regulations. The Investigator shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its LEC reporting obligations. Sponsor will promptly report to the Site, the Institution’s LEC, and IQVIA, any finding that could affect the safety of participants or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Institution’s LEC approval to continue the Study. 1.6 Use and Return of Investigational Product and Equipment Sponsor or a duly authorized agent of Sponsor, shall supply Institution with sufficient amount of Investigational Product as described in the Protocol. The Institution shall use the Investigational Product and any comparator products provided in connection with the Study, solely for the purpose of properly completing the Study and k Hodnocenému léčivu. Zkoušející je povinen poskytnout písemné prohlášení, jež bude odhalovat závazky Zkoušejícího, jsou-li nějaké, a to vůči Zdravotnickému zařízení ve vztahu a v souvislosti s prováděním Studie a Hodnoceným léčivem. Zdravotnické zařízení souhlasí, že zašle předem promptní oznámení Zadavateli a IQVIA v případě, že Zkoušející ukončí pracovní poměr ve Zdravotnickém zařízení či nebude-li Zkoušející z jakéhokoli jiného důvodu schopen provádět Studii. Ustanovení nového Zkoušejícího bude podléhat předchozímu schválení Zadavatele a IQVIA. Zdravotnické zařízení je tímto srozuměno a souhlasí s tím, že Zkoušející a IQVIA a/nebo Zadavatel uzavřou samostatnou smlouvu, která stanoví praktické povinnosti Zkoušejícího a úhradu za jeho plnění a plnění celého týmu zkoušejících.
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 NASDAQ Capital Market, (ii) a general moratorium on commercial banking activities in the State of Florida or United States, (iii) the outbreak or escalation of hostilities involving the United States or the declaration by the United States 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 Units 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 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 Units or the delivery of the Units on the terms and in the manner contemplated in the Prospectus.
Adverse Events. Institution will ensure, through Principal Investigator, reporting of adverse events experienced by Study Subjects in accordance with instructions in the Protocol and applicable regulations. This includes, where required, prompt reporting by telephone or facsimile to CRO and/or Pfizer. Accordingly, CRO and/or Pfizer will, so far as is lawful, have full responsibility for the reporting of all adverse events to local and international regulatory and/or health authorities. 7.3
Adverse Events. Promptly inform the Bank of the occurrence of any Event of Default or Default, or of any other occurrence which has or could reasonably be expected to have a materially adverse effect upon the Borrower's business, properties, or financial condition or upon the Borrower's ability to comply with its obligations under the Documents.
Adverse Events. The Investigator shall report adverse events and serious adverse events as directed in the Protocol and by Applicable Laws and regulations. The Investigator and Institution shall cooperate with Sponsor in its efforts to follow-up on any adverse events. Institution and Investigator shall comply with its EC reporting obligations. Sponsor will promptly report to the Institution and Investigator, the Institution’s EC, and CRO, any finding that could affect the safety of participants or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Institution’s IEC approval to continue the Study.
Adverse Events. Pharmacy must report adverse events to the ImmTrac Texas Immunization Registry and Authorizing Physician.15 Pharmacy must also notify the patient’s primary care provider of the administration of
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 or American Stock Exchange or The Nasdaq National Market, (ii) a general moratorium on commercial banking activities in Virginia or New York declared by either federal or state authorities, as the case may be, (iii) the outbreak or escalation of hostilities involving the United States or the declaration by the United States 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 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.
Adverse Events. The Investigator shall report adverse events and serious adverse events as directed in the Protocol and by applicable laws and regulations. The Investigator shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its EC reporting obligations. Sponsor will promptly report to the Site, the Site’s EC, and IQVIA, any finding that could affect the safety of participants or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Site’s EC approval to continue the Study. povahy, či odhalí jiné zájmy, je-li jich, a to v souvislosti s prováděním této Studie. Zkoušející souhlasí, že poskytne písemné prohlášení, jež bude veřejně odhalovat závazky Zkoušejícího, jsou-li nějaké, a to vůči Zdravotnickému zařízení ve vztahu a v souvislosti s prováděním Studie. Na konci Studie, přibližně dvanáct (12) měsíců po poslední návštěvě posledního Subjektu studie v celé Studii, vypracuje Zadavatel přehled výsledků klinického hodnocení, který poskytne Subjektům studie. Tento přehled bude interpretovat technické výsledky ve snadno srozumitelném jazyce. Zadavatel se s Místem provádění klinického hodnocení domluví na potřebném počtu výtisků a překladu tohoto přehledu. Na základě informací poskytnutých Místem provádění klinického hodnocení zašle smluvní dodavatel Zadavatele výtisky přehledu ▇▇▇▇▇ provádění klinického hodnocení. Místo provádění klinického hodnocení ▇▇▇▇ ▇▇▇ pověřená osoba bude zodpovídat za rozeslání přehledu Subjektům studie ▇▇▇▇ ▇▇ Subjektům studie případně ▇▇▇▇▇ ▇▇▇▇▇. Místo provádění klinického hodnocení souhlasí, že zašle předem promptní oznámení Zadavateli a IQVIA v případě, že Zkoušející ukončí pracovní poměr ve Zdravotnickém zařízení či nebude-li Zkoušející z jakéhokoli jiného důvodu ▇▇▇▇▇▇▇ provádět Studii. Ustanovení nového Zkoušejícího bude podléhat předchozímu schválení Zadavatele a IQVIA.
