Adverse Event Assessments Sample Clauses

Adverse Event Assessments. ‌ All AEs, which are 1) definitely related to, or 2) likely related to, the study ulcer or treatment will be documented on an AE form and assessed by the physician with respect to relatedness and severity. Each AE record will include a description of the event, date of onset, date of resolution, severity, treatment as applicable, and relationship to study device. Each AE must be recorded separately. Severity will be assessed using the following definitions: Mild: Aware of sign or symptom, but easily tolerated Moderate: Discomfort enough to cause interference with usual activity Severe: Incapacitating with inability to work or do usual activity Relationship to the study treatment or the study device will be assessed by the investigator using the following definitions: Likely: A temporal relationship exists between the event onset and the study procedure or device, and appears with some degree of certainty to be related based on the event symptoms and the nature of the study procedure or device. It cannot be readily explained by the subject’s clinical state or concomitant therapies.
Sample 1
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Related to Adverse Event Assessments

  • 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.

  • 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.

  • Risk Assessments a. Risk Assessment - Transfer Agent shall, at least annually, perform risk assessments that are designed to identify material threats (both internal and external) against Fund Data, the likelihood of those threats occurring and the impact of those threats upon the Transfer Agent organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”).

  • Ergonomic Assessments At the request of the employee, the College will ensure that an ergonomic assessment of the employee’s work station is completed by a person trained by the Department of Labor and Industries or comparable trainer to conduct ergonomic assessments. Solutions to identified issues/concerns will be implemented within available resources.

  • Loss Assessment We will pay up to $1000 for your share of loss assessment charged during the policy period against you by a corporation or as- sociation of property owners, when the assess- ment is made as a result of:

  • Conformity Assessment 1. The Parties recognize that a broad range of mechanisms exists to facilitate the acceptance of conformity assessment procedures and results thereby, including:

  • Conformity Assessment Procedures 1. Each Party shall give positive consideration to accepting the results of conformity assessment procedures of other Parties, even where those procedures differ from its own, provided it is satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to its own procedures.

  • Environmental Assessment and Mitigation Development of a transportation project must comply with applicable environmental laws. The party named in article 1, Responsible Parties, under AGREEMENT is responsible for the following:

  • Diagnostic Assessment 6.3.1 Boards shall provide a list of pre-approved assessment tools consistent with their Board improvement plan for student achievement and which is compliant with Ministry of Education PPM (PPM 155: Diagnostic Assessment in Support of Student Learning, date of issue January 7, 2013).

  • Self-Assessment (a) Subject to clause 4.4(b), for Services that are Self-Assessable:

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