ASSESSMENT OF ADVERSE EVENTS Sample Clauses

ASSESSMENT OF ADVERSE EVENTS. 3.1. Spontaneous Reports - Marketed Product N/A 3.2. Serious AEs from Clinical Studies Causality: Each Party will be responsible for the causality assessment of AEs in their own clinical studies.
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ASSESSMENT OF ADVERSE EVENTS. All SAEs whether volunteered by the Subject, discovered by Study personnel during questioning, or detected through physical examination, laboratory test, or other means will be reported appropriately. Each reported SAE will be described by its duration (i.e., start and end dates), regulatory seriousness criteria if applicable, suspected relationship to the rtPA (see following guidance), and actions taken.
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ASSESSMENT OF ADVERSE EVENTS. The site Investigator will be responsible for determining the event name, assessing the severity (i.e. grade), expectedness, and attribution of all adverse events.
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ASSESSMENT OF ADVERSE EVENTS. Adverse Events (AEs) will be graded as mild, moderate, or severe as defined in Section 8.4.3 of this protocol. AEs will be evaluated at the Injection visit post-treatment, follow-up Weeks 1, 2, 4, 8, and 16 or Early Termination visits, if applicable. Section 8.4.5 outlines the procedures for recording and reporting AEs. Adverse events will be reported by the Sponsor in accordance with “21CRF part 312.32 and Guidance for Industry and Investigators: Safety Reporting Requirements.” The Investigator will report any serious adverse events (SAEs) to the IRB.
Sample 1
ASSESSMENT OF ADVERSE EVENTS. Clinical Investigators will seek information on AEs at each subject contact. Subjects should be asked, using a general, non-direct question, if there has been any change in their general health. Direct questioning and examination should then be performed as appropriate. Severity of the AE should be assessed according to the following criteria: Regardless of severity, some AEs may also meet regulatory serious criteria refer to definitions and reporting of serious adverse events (SAEs) in Section 8.1.2. A Clinical Investigator who is qualified in medicine must make the determination of the relationship of the investigational drug, RBM-007 to each AE (related or not related). The Clinical Investigator should decide whether, in his or her medical judgment, there is a reasonable possibility that the RBM-007 caused the AE/SAE based on facts, evidence, scientific rationales, and clinical judgment. When assessing causality, the Clinical Investigator may consider the following information when determining the relationship to the RBM-007 for each AE: mechanism of action, biologic plausibility, confounding risk factors (i.e., medical history, concomitant medications), temporal relationship, dechallenge/rechallenge, and lack of alternative explanation. It should be specified if the AE is related to the injection procedure and not the study drug. • Not Related: The event is clearly related to other factors such as subject’s clinical condition, therapeutic interventions, concomitant disease or therapy administered to the subject and does not follow a known response pattern to the product.
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ASSESSMENT OF ADVERSE EVENTS. Assessment of Listedness (Expectedness) 8.1 All Adverse Events and Suspected Adverse Drug Reactions will be reported to Shire irrespective of any assessment regarding listedness (expectedness). 8.2 Shire shall be responsible for assessing all Adverse Events and Suspected Adverse Drug Reactions in the Territory and shall determine if any report is required to be made to the Regulatory Authorities in accordance with Section 10.
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Related to ASSESSMENT OF ADVERSE EVENTS

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

  • 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.

  • Notice of Adverse Change Recipient shall promptly notify OBDD of any adverse change in the activities, prospects or condition (financial or otherwise) of Recipient or the Project related to the ability of Recipient to perform all obligations required by this Contract.

  • Absence of Adverse Changes From the date hereof until the Closing, there will have been no material adverse change in the financial or business condition of the Company.21

  • Litigation; Adverse Effects (a) To the best of Borrower’s knowledge, there is no Proceeding, pending or threatened, against Borrower or any property of Borrower (including the Property), which, if adversely determined, would result in a Material Adverse Effect. (b) Except as disclosed on Schedule 5.11 hereto, Borrower is not (i) in violation of any applicable law, which violation has a Material Adverse Effect, or (ii) subject to or in default with respect to any Court Order which has a Material Adverse Effect.

  • Notice of Default, Litigation and Material Adverse Effect Promptly, and in any event within three Business Days after any officer of Holdings or any of its Subsidiaries obtains knowledge thereof, notice of (i) the occurrence of any event which constitutes a Default or an Event of Default, (ii) any litigation or governmental investigation or proceeding pending against Holdings or any of its Subsidiaries (x) which, either individually or in the aggregate, has had, or would reasonably be expected to have, a Material Adverse Effect or (y) with respect to any Credit Document, or (iii) any other event, change or circumstance that has had, or would reasonably be expected to have, a Material Adverse Effect.

  • 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.

  • 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:

  • Financial Statements; No Material Adverse Effect; No Internal Control Event (a) (i) The Audited Financial Statements (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein; (ii) fairly present the financial condition of Borrower and its Consolidated Subsidiaries as of the date thereof and their results of operations for the period covered thereby in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein; and (iii) show all material indebtedness and other liabilities, direct or contingent, of Borrower and its Consolidated Subsidiaries as of the date thereof, including liabilities for taxes, material commitments and Indebtedness. (b) The unaudited consolidated balance sheets of Borrower and its Consolidated Subsidiaries dated August 31, 2006, and the related consolidated statements of income or operations, shareholders’ equity and cash flows for the fiscal quarter ended on that date (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein, and (ii) fairly present the financial condition of Borrower and its Consolidated Subsidiaries as of the date thereof and their results of operations for the period covered thereby, subject, in the case of clauses (i) and (ii), to the absence of footnotes and to normal year-end audit adjustments. (c) Since the date of the Audited Financial Statements, there has been no event or circumstance, either individually or in the aggregate, that has had or could reasonably be expected to have a Material Adverse Effect. (d) To the best knowledge of Borrower, no Internal Control Event exists or has occurred since the date of the Audited Financial Statements that has resulted in or could reasonably be expected to result in a misstatement in any material respect, in any financial information delivered or to be delivered to Agent or Lenders, of (i) covenant compliance calculations provided hereunder or (ii) the assets, liabilities, financial condition or results of operations of Borrower and its Subsidiaries on a consolidated basis. (e) The forecasted balance sheet and statements of income and cash flows of Borrower and its Consolidated Subsidiaries delivered pursuant to Section 6.01(c) were prepared in good faith on the basis of the assumptions stated therein, which assumptions were fair in light of the conditions existing at the time of delivery of such forecasts, and represented, at the time of delivery, Borrower’s best estimate of its future financial condition and performance.

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