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

  • 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.

  • 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.

  • 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.

  • Billing Procedures The Supporting Party will xxxx the Protecting Party for actual costs incurred for Assistance by Hire. Reimbursements will be limited to the provisions of the Agreement and the applicable OP, regardless of whether or not it is authorized on the Resource Order or other documentation produced by the incident. Reimbursable costs may include transportation, salary, overtime, per diem and other approved expenses of Supporting agency personnel. Rates and conditions of use for the equipment and personnel are documented in the OP. Parties shall submit a xxxx within 90 days of the incident. Parties must use their own invoice form for billing under this Agreement to avoid any confusion with other services that may have been ordered under other agreements. Invoices must identify Supporting Party’s name, address, and Taxpayer Identification Number (Department only), fire name, order and request number, and xxxx number and amount. Invoice supporting documentation must include description of services performed, period of services performed, and any applicable cost share agreements. Supporting documentation will itemize details of billing, listing personnel, equipment, travel and per diem, aircraft, supplies and purchases as approved in the attached AOP. It will also include itemized deductions for maintenance and repair of equipment. Department invoices will include “Record of Activities” (FSLA-5) and U.S. Forest Service invoices will include transaction register. Invoices for services under this agreement must be sent to: Name: Xxxx Xxxxxx-Xxxxx, ECC Manager Address: 0000 Xxxxxxxxx Xxxxx Xxxx, Xxxxx, Xxx: Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 FAX: (000) 000-0000 Email: xxxxxxxxxxxx@xx.xxx.xx Name: Spalding Community Service District Address: 000-000 Xxxxxxxx Xxx Xxxx, Xxxxx, Xxx: Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 FAX: (000) 000-0000 Email: xxxxxxxxxxxxx@xxxxxxx.xxx All bills will have a payment due date 30 days upon receipt. Contested Xxxxxxxx: Written notice that a xxxx is contested will be mailed to the Party within 30 days of receipt of the invoice and will fully explain the contested items. Contested items should be resolved no later than 60 days following receipt of the written notice. Parties are responsible for facilitating resolution of contested xxxxxxxx. Billing requirements and rates are documented in the attached OP.

  • Changes in Accounting Procedures Any resolution passed by the Board of Trustees that affects accounting practices and procedures under this Agreement shall be effective upon written receipt of notice and acceptance by USBFS.

  • Hearing Procedures The hearing shall be held at the earliest convenient date, taking into consideration the established schedule of the Board or hearing officer and the availability of the CSEA representative, counsel and witnesses. The parties shall be notified of the time and place of the hearing after ensuring availability of all necessary parties. The employee shall be entitled to appear personally, produce evidence, and have CSEA representation. The employee shall be entitled to a public hearing if he/she demands it when the Board is hearing the appeal. 18.12.1 The complainant may also be represented by counsel. The procedure entitled "Administrative Adjudication" commencing with Government Code 11500 shall not apply to any such hearing before the Board or a hearing officer. Neither the Board nor a hearing officer shall be bound by rules of evidence used in California courts. Informality in any such hearing shall not invalidate any order or decision made or approved by the hearing officer or the Board. 18.12.2 All hearings shall be heard by a hearing officer (who shall be an attorney licensed in the State of California) except in those cases where the Board determines to hear the appeal itself. In any case in which the Board hears the appeal, the Board may use the services of its counsel or a hearing officer in ruling upon procedural questions, objections to evidence, and issues of law. However, the Board must employ separate counsel from the one presenting the case for the complainant. 18.12.3 If the appeal is heard by the Board, the Board shall affirm, modify or revoke the recommended personnel action. 18.12.4 If the appeal is heard by a hearing officer, he/she shall prepare a proposed decision in a form that may be adopted by the Board as the decision in the case. A copy of the proposed decision shall be received and filed by the Board and furnished to each party within ten days after the proposed decision is filed by the Board. After furnishing the proposed decision to each party, the Board may: 18.1.4.1 Adopt the proposed decision in its entirety. 18.1.4.2 Reduce the personnel action set forth in the proposed decision and adopt the balance of the proposed decision. 18.1.4.3 Reject a proposed reduction in personnel action, approve the disciplinary action sought by the complainant or any lesser penalty, and adopt the balance of the proposed decision. 18.1.4.4 Reject the proposed decision in its entirety. 18.12.5 If the Board rejects the proposed decision in its entirety, each party shall be notified of such action and the Board may decide the case upon the record including the transcript, with or without the taking of additional evidence, or may refer the case to the same or another hearing officer to take additional evidence. If the case is so assigned to a hearing officer, he/she shall prepare a proposed decision, as provided in item Section 18.12.4 above, upon the additional evidence and the transcript and other papers which are part of the record of the prior hearing. A copy of this proposed decision shall be furnished to each party within 10 days after the proposed decision is filed by the Board. 18.12.6 In arriving at a decision or a proposed decision on the propriety of the proposed disciplinary action, the Board or the hearing officer may consider the records of any prior disciplinary action proceedings against the employee in which a disciplinary action was ultimately sustained and any records that were contained in the employee's personnel files and introduced into evidence at the hearing.

  • 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.

  • Filing Procedures The Company shall (A) permit counsel to the Investor an opportunity to review and comment upon (i) each Registration Statement at least three (3) Trading Days prior to its filing with the SEC and (ii) all amendments and supplements to each Registration Statement (including, without limitation, the Prospectus contained therein) (except for Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any similar or successor reports or Prospectus Supplements the contents of which is limited to that set forth in such reports) within a reasonable number of days prior to their filing with the SEC, and (B) shall reasonably consider any comments of the Investor and its counsel on any such Registration Statement or amendment or supplement thereto or to any Prospectus contained therein. The Company shall promptly furnish to the Investor, without charge, (i) electronic copies of any correspondence from the SEC or the Staff to the Company or its representatives relating to each Registration Statement (which correspondence shall be redacted to exclude any material, non-public information regarding the Company or any of its Subsidiaries), (ii) after the same is prepared and filed with the SEC, one (1) electronic copy of each Registration Statement and any amendment(s) and supplement(s) thereto, including, without limitation, financial statements and schedules, all documents incorporated therein by reference, if requested by the Investor, and all exhibits and (iii) upon the effectiveness of each Registration Statement, one (1) electronic copy of the Prospectus included in such Registration Statement and all amendments and supplements thereto; provided, however, the Company shall not be required to furnish any document to the extent such document is available on XXXXX).

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