AE Reporting Requirements Sample Clauses

AE Reporting Requirements. For each AE the following information will be recorded: Name of Event: The Investigator should use standard medical terminology that clearly describes the pathophysiology of the event and identifies the body system affected. If the event is ocular the Investigator should include the eye that is affected; Onset Date: Date that the AE was first experienced at the reported severity and frequency; Resolution Date: Date that the AE was last experienced or was completely resolved. In the case of an AE that increases in severity or frequency, the resolution of the AE is the date that it was last experienced at that previously reported severity; Severity: All AEs will be graded according to the following: Grade 1 = Mild, easily tolerated by the patient, causing minimal discomfort and not interfering with everyday activities; Grade 2 =Moderate, sufficiently discomforting to interfere with normal everyday activities; Grade 3 =Severe, prevents normal, everyday activities; Grade 4 =Life threatening, places the patient in immediate risk of death;
Sample 1
AutoNDA by SimpleDocs

Related to AE Reporting Requirements

  • Definitions For purposes of this Agreement:

  • Notices Any notice, request or other document required or permitted to be given or delivered to the Holder by the Company shall be delivered in accordance with the notice provisions of the Purchase Agreement.

  • NOW, THEREFORE the parties hereto agree as follows:

  • IN WITNESS WHEREOF the parties hereto have executed this Agreement as of the day and year first above written.

  • Severability Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction.

  • Entire Agreement This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter contained in this Agreement and supersedes all prior agreements, understandings and negotiations between the parties.

  • General The Trustee shall keep proper books of record and account of all the transactions of each Trust under this Indenture at its corporate trust office, including a record of the name and address of, and the Units issued by each Trust and held by, every Unit holder, and such books and records of each Trust shall be open to inspection by any Unit holder of such Trust at all reasonable times during the usual business hours. The Trustee shall make such annual or other reports as may from time to time be required under any applicable state or federal statute or rule or regulations thereunder.

  • WHEREAS the Company desires the Warrant Agent to act on behalf of the Company, and the Warrant Agent is willing to so act, in connection with the issuance, registration, transfer, exchange, redemption and exercise of the Warrants; and

  • Termination This Agreement may be terminated at any time prior to the Closing:

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