ASSESSMENT OF ADVERSE EVENTS Sample Clauses

ASSESSMENT OF ADVERSE EVENTS. 3.1. Spontaneous Reports - Marketed Product N/A
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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. Reporting Form. Participating Site shall submit a separate Serious Adverse Event Reporting Form (“SAE Form”) for each Event within one (1) business day following the SAE. An SAE Form is provided as Exhibit D; and Completed SAE Forms shall be sent via email and fax to: Iszet Campo Xxxxxxxx, MPH University of Miami, Neurology Department 0000 XX 00xx Xxxxxx, Xxxxx 0000 Xxxxx, Xxxxxxx 00000 Email: xxxxxx@xxx.xxxxx.xxx Fax: (000) 000-0000
Sample 1
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. Assessment of Listedness (Expectedness)
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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: Mild: No interference with the subject's daily activities; no medical intervention/therapy required Moderate: Possible interference with the subject's daily activities; no or minimal medical intervention/therapy required Severe: Considerable interference with the subject's daily activities; medical intervention/therapy required 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.
Sample 1
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

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.

  • Material Adverse Events Since the date of the latest audited financial statements included within the SEC Reports, except as specifically disclosed in a subsequent SEC Report filed prior to the date hereof, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or required to be disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any officer, director or “Affiliate” (defined as any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 144 under the Act), except pursuant to existing Company stock option plans. The Company does not have pending before the Commission any request for confidential treatment of information. No event, liability or development has occurred or exists with respect to the Company or its Subsidiaries or their respective business, properties, operations or financial condition, that would be required to be disclosed by the Company under applicable securities laws at the time this representation is deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation is deemed made.

  • Notice of Adverse Change The Company shall promptly give notice to all holders of any Securities (but in any event within seven (7) days) after becoming aware of the existence of any condition or event which constitutes, or the occurrence of, any of the following:

  • Absence of Adverse Changes Since the date of the Company Balance Sheet to the date of this Agreement, there has not occurred any change, event, circumstance or development that is reasonably likely to have a Company Material Adverse Effect. From the date of the Company Balance Sheet until the date of this Agreement, except as contemplated hereby, (a) the business of the Company and its subsidiaries, taken as a whole, has been conducted in the ordinary course of business and (b) none of the Company or any of its subsidiaries has taken any action that would have required the consent of the Parent under Section 5.1 of this Agreement, had such action or event occurred after the date of this Agreement.

  • Notification of Events of Default and Adverse Developments The Borrower shall promptly notify the Lender upon obtaining knowledge of the occurrence of:

  • Litigation; Adverse Effects Except as set forth in Schedule 7.1-I, as of the Closing Date, there is no action, suit, proceeding, Claim, investigation or arbitration before or by any Governmental Authority or private arbitrator pending or, to the knowledge of the Borrower, threatened against the Company, the Borrower, any Qualified Borrower or any of their respective Subsidiaries, or any Property of any of them (i) challenging the validity or the enforceability of any of the Loan Documents, (ii) which will or is reasonably likely to result in a loss in excess of $30,000,000, or (iii) under the Racketeering Influenced and Corrupt Organizations Act or any similar federal or state statute where such Person is a defendant in a criminal indictment that provides for the forfeiture of assets to any Governmental Authority as a potential criminal penalty. There is no material loss contingency within the meaning of GAAP which has not been reflected in the consolidated financial statements of the Company and the Borrower. None of the Company, any General Partner, the Borrower, any Qualified Borrower or any Subsidiary of the Borrower is (A) in violation of any applicable Requirements of Law which violation will have or is reasonably likely to have a Material Adverse Effect, or (B) subject to or in default with respect to any final judgment, writ, injunction, restraining order or order of any nature, decree, rule or regulation of any court or Governmental Authority which will have or is reasonably likely to have 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.

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