Adverse Event Treatment, Follow-up, and Outcome Sample Clauses

Adverse Event Treatment, Follow-up, and Outcome. Treatment of any adverse events will be determined by the Investigator using his/her best medical judgment and according to current clinical practice guidelines. All applied measures as well as follow-up will be recorded in the appropriate eCRF. The Investigator will continue follow-up on adverse events, including laboratory abnormalities and solicited adverse events, until the event has resolved, is otherwise satisfactorily explained, or the participant completes the study. The resolution date will be recorded on the eCRF as the last date on which the participant experienced the adverse event. If an adverse event resolution date is uncertain the Principal Investigator should estimate the completion date based on medical judgment and interview of the participant. Approximate dates of resolution from phone or other communications may be taken as adverse event resolution dates. Some examples of estimation of adverse event resolution are: 1) an asymptomatic laboratory abnormality on one visit that has not been followed-up between visits but has resolved by the next visit may be assumed to have resolved by the midpoint of the inter-visit interval; 2) A resolved adverse event that was treated may be assumed to have been resolved by the end of treatment. Adverse events that are still present at the end of the study should be recorded as ongoing. Information recorded on the eCRF must be substantiated in the source documents. If an adverse event evolves into a condition that becomes “serious,” it will be designated as serious on the adverse event eCRF and a supplemental SAE Report form will be completed. Follow-up for SAEs must continue until resolution and the outcome reported to the Sponsor, even if this extends beyond the SAE reporting period (the end of the influenza season into which the participant is enrolled). For analysis purposes, the outcome for SAEs will be determined on or before the end of the second influenza season. Outcome of all adverse events will be classified as one of the following: • Resolved • Resolved with sequelae • Ongoing • Death If at any time after completion of the SAE reporting period the Investigator becomes aware of a serious adverse event that is suspected by the Investigator to be related to the study vaccine, the event must be reported to the Sponsor.
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Related to Adverse Event Treatment, Follow-up, and Outcome

  • 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.

  • Substance Abuse Treatment Information Substance abuse treatment information shall be maintained in compliance with 42 C.F.R. Part 2 if the Party or subcontractor(s) are Part 2 covered programs, or if substance abuse treatment information is received from a Part 2 covered program by the Party or subcontractor(s).

  • CHILD AND DEPENDENT ADULT/ELDER ABUSE REPORTING CONTRACTOR shall establish a procedure acceptable to ADMINISTRATOR to ensure that all employees, agents, subcontractors, and all other individuals performing services under this Agreement report child abuse or neglect to one of the agencies specified in Penal Code Section 11165.9 and dependent adult or elder abuse as defined in Section 15610.07 of the WIC to one of the agencies specified in WIC Section 15630. CONTRACTOR shall require such employees, agents, subcontractors, and all other individuals performing services under this Agreement to sign a statement acknowledging the child abuse reporting requirements set forth in Sections 11166 and 11166.05 of the Penal Code and the dependent adult and elder abuse reporting requirements, as set forth in Section 15630 of the WIC, and shall comply with the provisions of these code sections, as they now exist or as they may hereafter be amended.

  • Reasonable Suspicion Testing The Employer may, but does not have a legal duty to, request or require an employee to undergo drug and alcohol testing if the Employer or any supervisor of the employee has a reasonable suspicion (a belief based on specific facts and rational inferences drawn from those facts) related to the performance of the job that the employee:

  • Non-Paid Status During Treatment After Positive Test The employee will be in a non-pay status during any absence for evaluation or treatment, while participating in a rehabilitation program.

  • Certification Regarding Debarment, Suspension, and Other Responsibility Matters – Primary Covered Transactions The Firm certifies to the best of its knowledge and belief, that it and its principals:

  • CFR Part 200 or Federal Provision - Xxxx Anti-Lobbying Amendment - Continued If you answered "No, Vendor does not certify - Lobbying to Report" to the above attribute question, you must download, read, execute, and upload the attachment entitled "Disclosure of Lobbying Activities - Standard Form - LLL", as instructed, to report the lobbying activities you performed or paid others to perform. 2 CFR Part 200 or Federal Provision - Federal Rule Compliance with all applicable standards, orders, or requirements issued under section 306 of the Clean Air Act (42 U.S.C. 1857(h)), section 508 of the Clean Water Act (33 U.S.C. 1368), Executive Order 11738, and Environmental Protection Agency regulations (40 CFR part 15). (Contracts, subcontracts, and subgrants of amounts in excess of $100,000) Pursuant to the above, when federal funds are expended by ESC Region 8 and TIPS Members, ESC Region 8 and TIPS Members requires the proposer certify that in performance of the contracts, subcontracts, and subgrants of amounts in excess of $250,000, the vendor will be in compliance with all applicable standards, orders, or requirements issued under section 306 of the Clean Air Act (42 U.S.C. 1857(h)), section 508 of the Clean Water Act (33 U.S.C. 1368), Executive Order 11738, and Environmental Protection Agency regulations (40 CFR part 15). Does vendor certify compliance? Yes

  • Rate Redetermination after Catastro- phic Damage In event of Catastrophic Damage and ad- justment, if any, of Included Timber, Contracting Officer shall make an appraisal to determine for each species the catastrophe-caused difference between the appraised unit value of Included Timber remaining immediately prior to the catastrophe and the appraised unit value of existing and potential Included Timber immediately after the ca- tastrophe. Included Timber is any that would not be elimi- nated under B8.32. Potential Included Timber is any that would be added under B8.32. Tentative Rates and Flat Rates in effect at the time of catastrophe shall be adjusted by said differences to be- come the redetermined rates for the purpose of a contract modification under B8.32. Accordingly, Base Rates shall be adjusted to correspond to the redetermined rates if redetermined rates are less than the original Base Rates, subject to new Base Rate limitations of 25 cents per hun- dred cubic feet or equivalent. However, existing Base In- dices shall not be changed under this Subsection. Upon agreement under B8.32, redetermined rates and Required Deposits shall be considered established under B3.1 for timber Scaled subsequent to Catastrophic Damage. At time of such appraisal, Specified Road construc- tion cost shall include the estimated cost of any construc- tion work listed in the Schedule of Items performed and abandoned.

  • National Treatment and Most-favoured-nation Provisions (1) Neither Contracting Party shall in its territory subject investments or returns of nationals or companies of the other Contracting Party to treatment less favourable than that which it accords to investments or returns of its own nationals or companies or to investments or returns of nationals or companies of any third State.

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