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...
Sample 1
AutoNDA by SimpleDocs

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.

  • 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.

  • No Company Material Adverse Effect Since the date of this Agreement, there shall not have occurred any Company Material Adverse Effect.

  • Reporting Unauthorized Transactions You should notify us immediately if you believe your Access Codes or any Access Devices have been lost or stolen, that someone has gained access to the Security Procedure, or that someone has transferred or may transfer money from your Account without your permission or if you suspect any fraudulent activity on your Account. To notify us, call us at the number provided in Section 9.6 between 8:00 a.m. to 4:30 p.m. Central Time during a Business Day.

  • Resolution of Adverse Effects If FEMA determines that an Undertaking may adversely affect a historic property, it shall resolve the effects of the Undertaking in consultation with the SHPO, Grantee(s), subgrantee, participating Tribes the ACHP, if participating, and other consulting parties, by one of the following methods depending upon the severity of the adverse effect(s) as well as determination of the historic property’s significance on a local, state or national level. When FEMA determines an Undertaking will adversely affect an NHL, FEMA shall notify and invite the Secretary and ACHP to participate in consultation in accordance with 36 CFR § 800.10. When the ACHP participates in consultation related to an NHL, the ACHP shall report the outcome of the consultation to the Secretary and the FEMA Administrator.

  • Material Adverse Effect The occurrence of any event or condition that has had, or could reasonably be expected to have, a Material Adverse Effect.

  • Incident Reporting Transfer Agent will use commercially reasonable efforts to promptly furnish to Fund information that Transfer Agent has regarding the general circumstances and extent of such unauthorized access to the Fund Data.

  • Material Adverse Change A Material Adverse Change occurs;

  • Expected Outcomes The educational goals and objectives for improving student achievement, including how much academic improvement students are expected to show each year, how student progress and performance will be evaluated and the specific results to be attained, as described in Section 5a of the application: Student Performance, Assessment and Evaluation.

  • Reporting of Unauthorized Disclosure The Contractor shall immediately report to the State any unauthorized disclosure of confidential information.

Time is Money Join Law Insider Premium to draft better contracts faster.