Solicited Adverse Events Sample Clauses

Solicited Adverse Events. Solicited adverse events are events the participant is specifically asked about. These adverse events are commonly observed soon after receipt of vaccines and relate to local and systemic signs and symptoms. Solicited adverse events will be collected for 7 days post-vaccination1. These will be recorded daily in the eDiary for all participants. Participants in the immunogenicity cohort will also have an in-clinic assessment on Day 7 (+3 days). Solicited adverse events will also be reviewed during the telephone calls on Day 1 (+2 days) (all participants) and Day 7 (+3 days) (main cohort only). For this study, solicited adverse events to be collected include: • Vaccination site reactions: pain, induration, warmth, erythema (redness) • Systemic adverse events: feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, malaise 1 In the event that they persist longer than 7 days then an adverse event will be recorded Participants will be asked to record the presence of these symptoms and grade the severity as described in Section 5.3.1. Oral temperature will be measured using the thermometer provided and the diameter of induration will be measured with the tape measure provided.
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Solicited Adverse Events. With the exception of the Day 7 (+3 days) in-clinic assessment for participants in the immunogenicity cohort, the severity of solicited adverse events will be made by the participant. Severity will be assigned using the definitions in Appendix 3.
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Related to Solicited 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.

  • 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.

  • Other Material Species or products not listed in A2, upon written approval of Contracting Officer under B3.41. B2.2 Utilization and Removal of Included Timber. “Utilization Standards” for trees and minimum pieces are stated in A2. To meet minimum tree specifications, trees must equal or exceed tree diameters listed in A2 and con- tain at least one minimum piece. Except for timber re- quired or authorized to be left, Purchaser shall fell and buck such trees and shall remove from Sale Area and present for Scaling all pieces that:

  • DISCLOSURE OF TBS ACCESS CODE TO THIRD PARTY (a) The Account Holder must exercise all care to ensure that the TBS Access Code is not disclosed to any person and shall take all steps to prevent forgery or fraud in connection with the use of his TBS Access Code and/or the operation of the TBS. If the TBS Access Code is disclosed to any person, the Account Holder must forthwith give the Bank written notice thereof, thereupon the Account Holder shall immediately cease to use the TBS Access Code.

  • COMMERCIALLY SENSITIVE INFORMATION 1. The Authority acknowledges that the Contractor has requested that the following information be treated as Commercially Sensitive Information; Document Page Number Section Condition or Paragraph Number Explanation of harm which may result from disclosure and time period applicable to sensitivity.

  • Sensitive Information Buyer will inform Licensor if Personal Data falls into any special categories of personal data as defined in Article 9(1) of Regulation (EU) 2016/679.

  • Handling Sensitive Personal Information and Breach Notification A. As part of its contract with HHSC Contractor may receive or create sensitive personal information, as section 521.002 of the Business and Commerce Code defines that phrase. Contractor must use appropriate safeguards to protect this sensitive personal information. These safeguards must include maintaining the sensitive personal information in a form that is unusable, unreadable, or indecipherable to unauthorized persons. Contractor may consult the “Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals” issued by the U.S. Department of Health and Human Services to determine ways to meet this standard.

  • Alert Information As Alerts delivered via SMS, email and push notifications are not encrypted, we will never include your passcode or full account number. You acknowledge and agree that Alerts may not be encrypted and may include your name and some information about your accounts, and anyone with access to your Alerts will be able to view the contents of these messages.

  • Informal Observation Additional evaluation of employees may occur through informal observations by the Employer. It may not be necessary to reduce such evaluations to writing, and a verbal discussion between the Employer and the employee concerning the informal observations may suffice. If a written evaluation is deemed necessary, Procedures C and D as outlined above shall be followed.

  • Důvěrné informace V průběhu klinického hodnocení mohou zdravotnické zařízení a hlavní zkoušející získávat nebo vytvářet informace, které jsou důvěrnými informacemi zadavatele nebo jeho přidružené strany.

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