Reporting Procedures for Adverse Events Sample Clauses

Reporting Procedures for Adverse Events. The investigator is responsible for ensuring that all AEs observed or reported by the subject that occur after signing of the informed consent throughout the study until the final study visit are reported. At each visit, the investigator / delegate will determine whether any AEs have occurred. If known, the medical diagnosis of an adverse event should be recorded in preference to the listing of individual signs and symptoms. The investigator will evaluate any changes in laboratory values if laboratory testing is performed, and make a determination as to whether or not the change is clinically important to be reported as an adverse event, and whether or not the changes were related to the study drug(s). In general, abnormal laboratory findings without clinical significance (based on the investigator's judgment) should not be recorded as AEs. However, laboratory value changes that the investigator considers clinically significant or requiring treatment / adjustment in current therapy are considered AEs. Where applicable, the clinical sequelae (not the laboratory abnormality) should be recorded as the adverse event. Every adverse event must be assessed and the eCRF entry reviewed and confirmed by the investigator. All ocular AEs should indicate which eye the adverse event occurred (Oculus sinister (OS) [left], oculus dextrus (OD) [right], oculus uterque (OU) [both]). The investigator has overall responsibility to ensure that the following adverse event attributes are assigned: • Adverse event diagnosis or syndrome(s), if known (if not known, signs or symptoms) • Dates of onset and resolution • Severity [and/or toxicity per protocol] • Assessment of relatedness to study drug(s) • Action taken If any AEs are present when a participant completes the study or when a participant is discontinued from the study, the Investigator / delegate should make every effort to follow-up the participant until the adverse event has resolved or stabilized. All follow-up information (and attempted follow-up contacts) should be documented in the participant’s medical records. If an adverse event changes in severity, it should be a single entry in the eCRF, and assigned the highest severity experienced. The adverse event toxicity grading scale used will be the National Institutes of Health Common Terminology Criteria for Adverse Events (CTCAE, Version 4). If the adverse event is not specified in the CTCAE, the severity will be assessed on the following scale with appropriate clinic...
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Related to Reporting Procedures for 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.

  • 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).

  • 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.

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • 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.

  • Accounting Procedures 7.3.1. Principal and Interest Computation.......................... 7.3.2.

  • 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.

  • 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.

  • 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.

  • Standard Operating Procedures Over approximately the past eight years, the Parties have been supplying select Products to one another for use in the operation of their respective businesses within the United States of America, Canada and Mexico. The Parties developed and been following certain standard operating procedures in connecting with, among other topics, forecasting, production planning, ordering, delivering and resolving claims on the Products supplied to one another (the “Current SOPs”). The Parties will be updating their respective business systems over the next six months, and the updates to these business systems will require the Parties to modify the Current SOPs. Once the Parties have completed the updates to the business systems and agreed on the necessary modifications to the Current SOPs, the Parties will sign a written amendment to this Agreement appending the updated standard operating procedures (the “Updated SOPs”). Until the Parties have signed a written amendment appending the Updated SOPs, the parties will continue to follow the Current SOPs. The Parties will comply with the applicable SOPs in connection with the purchase and sale of products identified in a Purchase Schedule. The Parties may add terms and conditions to, and amend the terms and conditions of, the SOP in a Purchase Schedule, but any additional and amended terms and conditions in a Purchase Schedule supplementing and modifying the SOP will only apply the specific products identified in that Purchase Schedule for its duration.

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