Reporting Procedures for Serious Adverse Events Sample Clauses

Reporting Procedures for Serious Adverse Events. The investigator is responsible for ensuring that all SAEs observed by the investigator or reported by the subject that occur after signing of the informed consent through the week 24 follow-up visit are recorded in the participant’s medical record. Any SAE (including death) that occurs during the course of the study, whether or not related to the study drug(s) due to any cause, must be reported immediately on the SAE form (within 24 hours of the investigator becoming aware of the event) The investigator (or designee) will be requested to complete the SAE form associated with the study including as much information regarding the event that is available at the time of the initial report. reviewed reporting The investigator must review and sign-off each SAE report to confirm that they have the SAE and the details are correct; however, this sign-off must not delay the initial and may be undertaken after the initial report has been made. Prompt notification is essential so that legal requirements and ethical obligations to the participants participating in the study can be met. The Investigator must also: • Report all SAEs to the reviewing IEC / IRB within the time-line specified by the reviewing body per the respective reporting requirements; Opthea will report SAEs and / or SUSARs as required to regulatory authorities, investigators / institutions, and IRBs / IECs as applicable in compliance with all reporting requirements according to local regulations and good clinical practice.
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Related to Reporting Procedures for Serious Adverse Events

  • Reporting Procedures Enter in the XXX Entity Management area the information that XXX requires about each proceeding described in paragraph 2 of this award term and condition. You do not need to submit the information a second time under assistance awards that you received if you already provided the information through XXX because you were required to do so under Federal procurement contracts that you were awarded.

  • 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.

  • Complaints by Bidders and Handling of Complaints (ix) The Recipient shall implement an effective and independent protest mechanism allowing bidders to protest and to have their protests handled in a timely manner. Fraud and Corruption

  • Drug Testing Procedures a. The testing procedures and safeguards provided in this policy shall be adhered to by any laboratory personnel administering departmental drug tests.

  • Billing Procedures (a) PROVIDER agrees all claims shall be submitted to OHCA in a format acceptable to OHCA and in accordance with the OHCA Provider Manual.

  • Important Information About Procedures for Opening a New Account To help the government fight the funding of terrorism and money laundering activities, Federal law requires all financial organizations to obtain, verify, and record information that identifies each person who opens an account. What this means for you: When you open an account, you are required to provide your name, residential address, date of birth, and identification number. We may require other information that will allow us to identify you.

  • Reporting Procedure The Company and the Union agree that any allegation of harassment should be dealt with in an expeditious manner, and they will encourage their respective representatives to do all they can to ensure that delays in dealing with such allegations are minimized. The process must be fair, consistent, and expeditious. This procedure is not intended to preclude any other existing recourse that may be available to an employee (e.g. redress through the collective agreement, a Human Rights complaint, criminal charges, or civil litigation).

  • Hearing Procedures The hearing shall be conducted to preserve its privacy and to allow reasonable procedural due process. Rules of evidence need not be strictly followed, and the hearing shall be streamlined as follows:

  • Testing Procedures Testing will be conducted by an outside certified Agency in such a way to ensure maximum accuracy and reliability by using the techniques, chain of custody procedures, equipment and laboratory facilities which have been approved by the U.S. Department of Health and Human Services. All employees notified of a positive controlled substance or alcohol test result may request an independent test of their split sample at the employee’s expense. If the test result is negative the Employer will reimburse the employee for the cost of the split sample test.

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