Reporting a Serious Adverse Event Sample Clauses

Reporting a Serious Adverse Event. All serious adverse events (as described in section 7.1.5.1) that occur either during the study period (including the protocol-defined follow-up period), regardless of judged relationship to the study drug, or after the study period, if considered related to study drug or to the patient’s participation in the study, must be immediately reported to ORION Pharmacovigilance . The report must be made within 24 hours of the investigator’s knowledge of the event. In addition, a blood sample will be obtained for measurement of the concentration of IPP-201101 from all patients who have a serious adverse event recorded as related to study drug (see also section 7.1.6). Within 24 hours of the investigator’s awareness of the serious adverse event, the investigator must provide ORION Pharmacovigilance, by facsimile, with a signed Serious Adverse Event Transmittal Form completed to the greatest extent possible and a copy of all relevant source documents, including the corresponding completed adverse event, medical history, and concomitant medications pages of the CRF as appropriate. (For adverse event reporting instructions see section 7.1.2.). If it is not possible to complete all sections of the SAE form within 24 hours, transmission of the form must not be delayed and the outstanding information should be sent on a follow-up SAE form. If the SAE is reported by telephone, all points on the SAE form should be covered in the initial telephone report and followed by a completed and signed SAE form to confirm the verbal information previously reported. Information on SAEs will be recorded on a specific Non Carbon Repeat (NCR) SAE form. Blank copies are included in the study Investigator’s File. The SAE form must be completed as fully as possible with information relevant to the SAE(s) being reported. All fields should be populated or marked accordingly if no information is available. In cases of death reported as an SAE, the report should detail the main and contributory causes of death. This information should also be accompanied by a death certificate or autopsy report, if available. For all SAEs where important or relevant information is missing, active follow-up should be undertaken. Investigators or other site personnel should inform the ORION Clinical Services’ Pharmacovigilance Department of any follow-up information on a previously reported SAE. The follow-up information must be presented on an SAE form marked as follow-up. It is necessary only to provide the new...
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Related to Reporting a Serious Adverse Event

  • 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.

  • 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.

  • No Material Adverse Event Since the respective dates as of which information is disclosed in the Registration Statement, the Prospectus and the Incorporated Documents, except as otherwise stated therein, there shall not have been (i) any change or decrease in previously reported results specified in the letter or letters referred to in paragraph (d) of this Section 6 or (ii) any change, or any development involving a prospective change, in or affecting the condition (financial or otherwise), earnings, business or properties of the Company and its subsidiaries taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated in the Registration Statement, the Prospectus and the Incorporated Documents (exclusive of any amendment or supplement thereto) the effect of which, in any case referred to in clause (i) or (ii) above, is, in the sole judgment of the Manager, so material and adverse as to make it impractical or inadvisable to proceed with the offering or delivery of the Shares as contemplated by the Registration Statement (exclusive of any amendment thereof), the Incorporated Documents and the Prospectus (exclusive of any amendment or supplement thereto).

  • Notice of Material Adverse Change Firm agrees to notify Citizens in writing of any “Material Adverse Change” to Firm within ten (10) days of said change. A “Material Adverse Change” means: (i) a change in the business operations or financial condition of Firm which negatively impacts its capacity to meet its professional or financial obligations;

  • Company Material Adverse Effect Since the date of this Agreement, there shall not have been any Company Material Adverse Effect or any event, change, or effect that would, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.

  • 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.

  • Notice of Material Adverse Effect The Company shall notify the Buyer (and any subsequent holder of the Debentures), as soon as practicable and in no event later than three (3) business days of the Company’s knowledge of any Material Adverse Effect on the Company. For purposes of the foregoing, “knowledge” means the earlier of the Company’s actual knowledge or the Company’s constructive knowledge upon due inquiry.

  • 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.

  • Absence of Material Adverse Change On the Closing Date, no circumstance shall exist that constitutes a REIT II Material Adverse Effect.

  • Absence of Material Adverse Changes No material adverse change in the business, assets, financial condition, or prospects of the Company shall have occurred, no substantial part of the assets of the Company not substantially covered by insurance shall have been destroyed due to fire or other casualty, and no event shall have occurred which has had or will have a material adverse effect on the business, assets, financial condition or prospects of the Company.

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