Serious Adverse Events 1 Sample Clauses

Serious Adverse Events 1. Eventos adversos xxxxxx Physician is responsible for the identification, collection, reporting and documentation of Serious Adverse Events (“SAEs”) in patient(s) participating in the Protocol. Institution and Physician are responsible for complying with all Applicable Laws concerning the reporting of Suspted Unexpected Serious Adverse Reactions (“SUSARs”) to the Institutional Review Board (“IRB”) or Ethics Committee (“EC”), as the case may be, and to regulatory authorities in in connection with the Protocol. Notwithstanding the foregoing, Institution and Physician will comply with IRB/EC reporting instructions and all Applicable Laws regarding SAE reporting. El médico es responsable de la identificación, recogida, notificación y documentación de los acontecimientos adversos xxxxxx ("SAE") en los pacientes que participan en el protocolo. La Institución y el Médico son responsables de cumplir con todas las Leyes Aplicables relativas a la notificación de Sospechas de Reacciones Adversas Xxxxxx Inesperadas ("SUSARs") al Consejo de Revisión Institucional ("IRB") o al Comité de Ética ("EC"), según sea el caso, y a las autoridades reguladoras en México en relación con el Protocolo. Sin perjuicio de lo anterior, la Institución y el Médico cumplirán con las instrucciones de reporte del CEI o del Comité de Ética y con todas las Leyes Aplicables en materia de reporte de SAE. The Physician will collect Adverse Events (“AEs”) and SAEs for patient(s) receiving Investigational Product at the Institution as per protocol. Physician will record seriousness, causality and expectedness assessments for each AE as per Institution’s policies. All SAEs provided to Ultragenyx must have the Physician’s assessment of seriousness, causality and expectedness. Events not listed in the Investigator Brochure (“IB”) are considered “unexpected” and events listed in the IB are considered “expected.” The Institution and/or Physician is responsible for determining the reportability of each assessed SAE. All SAEs considered by the Physician as unexpected per the IB and Investigational Product related must be reported as a SUSAR by the Physician to the relevant regulatory authorities in and IRB/EC in accordance with Applicable Laws. El médico recogerá los acontecimientos adversos ("EA") y los EAE de los pacientes que reciban el producto en investigación en la institución según el protocolo. El médico registrará las evaluaciones de gravedad, causalidad y previsibilidad de cada EA según las polít...
Sample 1
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Related to Serious Adverse Events 1

  • 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 Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Professional Development; Adverse Consequences of School Exclusion; Student Behavior The Board President or Superintendent, or their designees, will make reasonable efforts to provide ongoing professional development to Board members about the adverse consequences of school exclusion and justice-system involvement, effective classroom management strategies, culturally responsive discipline, appropriate and available supportive services for the promotion of student attendance and engagement, and developmentally appropriate disciplinary methods that promote positive and healthy school climates, i.e., Senate Bill 100 training topics. Board Self-Evaluation The Board will conduct periodic self-evaluations with the goal of continuous improvement. New Board Member Orientation The orientation process for newly elected or appointed Board members includes:

  • Serious Health Condition An illness, injury, impairment, or physical or mental condition which warrants the participation of a family member to provide care during a period of treatment or supervision and involves either inpatient care in a hospital, hospice or residential health care facility or continuing treatment or continuing supervision by a health care provider (e.g. physician or surgeon) as defined by state and federal law.

  • Infectious Disease Where an employee produces documentary evidence that:

  • Serious Illness Should a participant be unable to take the leave when scheduled because of serious injury or illness occurring before commencement of the leave, he/she may cancel the leave and receive payment as in Article 12.8.3.9 or, with the consent of the College, defer the leave to a time mutually agreeable, not to exceed one (1) year.

  • Infectious Diseases The Employer and the Union desire to arrest the spread of infectious diseases in the nursing home. To achieve this objective, the Joint Health and Safety Committee may review and offer input into infection control programs and protocols including surveillance, outbreak control, isolation, precautions, worker education and training, and personal protective equipment. The Employer will provide training and ongoing education in communicable disease recognition, use of personal protective equipment, decontamination of equipment, and disposal of hazardous waste.

  • FLORIDA CONVICTED/SUSPENDED/DISCRIMINATORY COMPLAINTS By submission of an offer, the respondent affirms that it is not currently listed in the Florida Department of Management Services Convicted/Suspended/Discriminatory Complaint Vendor List.

  • Independence from Material Breach Determination Except as set forth in Section X.D.1.c, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for OIG’s decision that CHSI has materially breached this CIA, which decision shall be made at OIG’s discretion and shall be governed by the provisions in Section X.D, below.

  • Financial Viability and Regulatory Compliance 4.6.1 The Contractor warrants and represents that its corporate entity is in good standing with all applicable federal, state, and local licensing authorities and that it possesses all requisite licenses to perform the services required by this contract. The Contractor further warrants and represents that it owes no outstanding delinquent federal, state, or local taxes or business assessments.

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