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...
Sample 1
AutoNDA by SimpleDocs

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.

  • 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 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.

  • 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.

  • 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.

  • 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.

  • Standard Operating Procedures Standard Operating Procedures shall not contravene the Canada Labour Code, the Canadian Human Rights Code, or the Collective Agreement, and an allegation of such contravention is subject to the grievance procedure.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!