Required Time-Sensitive Notification Sample Clauses

Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s Representative (COR) as follows:
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Required Time-Sensitive Notification. Under the contract, the Contractor must submit to the Contracting Officer’s representative (COR) as follows:
Sample 1Sample 2
Required Time-Sensitive Notification a. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible BARDA representative or the COR/ACOR /ACOR as follows: Expedited safety report of unexpected or life-threatening experience or death. A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven (7) days after the IND sponsor’s receipt of the information, must be submitted to BARDA representative or COR/ACOR /ACOR within 24 hours of FDA notification. Expedited safety reports of serious and unexpected adverse experiences. A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 days after the IND sponsor’s receipt of the information, must be submitted to the BARDA representative or COR/ACOR /ACOR within 24 hours of FDA notification. IDE reports of unanticipated adverse device effect. A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to BARDA representative or COR/ACOR /ACOR within 24 hours of FDA notification. Expedited safety reports. Sent to BARDA representative or the COR/ACOR /ACOR concurrently with the report to FDA. Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported to BARDA annually.
Sample 1
Required Time-Sensitive Notification a. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible BARDA representative or the COR as follows: Expedited safety report of unexpected or life-threatening experience or death. A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than representative or COR within 24 hours of FDA notification. Expedited safety reports of serious and unexpected adverse experiences. A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 days after the IND receipt of the information, must be submitted to the BARDA representative or COR within 24 hours of FDA notification. IDE reports of unanticipated adverse device effect. A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to BARDA representative or COR within 24 hours of FDA notification. Expedited safety reports. Sent to BARDA representative or the COR concurrently with the report to FDA. Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported to BARDA annually.
Sample 1

Related to Required Time-Sensitive Notification

  • Sick Leave Notification Employees must contact their supervisor or assistant manager or designee at least one (1) hour prior to the start of their assigned shift at the designated contact number to be placed on the sick board. Employees wishing to return to work must notify their supervisor or assistant manager before 4:00 pm of the day before desiring to return to work.

  • Recall Notification Notice of recall shall be sent to the bargaining unit member by certified mail. The City shall be deemed to have fulfilled its obligation by mailing the recall notice by certified mail, return receipt requested, to the last address provided by the bargaining unit member.

  • Handling Sensitive Personal Information and Breach Notification A. As part of its contract with HHSC Contractor may receive or create sensitive personal information, as section 521.002 of the Business and Commerce Code defines that phrase. Contractor must use appropriate safeguards to protect this sensitive personal information. These safeguards must include maintaining the sensitive personal information in a form that is unusable, unreadable, or indecipherable to unauthorized persons. Contractor may consult the “Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals” issued by the U.S. Department of Health and Human Services to determine ways to meet this standard.

  • Notification of Absence To be entitled to payment in accordance with this clause the employee shall meet the following criteria;

  • Employee Notification A copy of any disciplinary action or material related to employee performance which is placed in the personnel file shall be provided to the employee (the employee so noting receipt, or the supervisor noting employee refusal to acknowledge receipt) or sent by certified mail (return receipt requested) to the employee's last address appearing on the Employer's records.

  • Cancellation of electronic bill notification The electronic Xxxxxx reserves the right to cancel the presentment of electronic bills at any time. You may cancel electronic bill presentment at any time. The timeframe for cancellation of your electronic bill presentment may vary from Xxxxxx to Xxxxxx. It may take up to sixty (60) days, depending on the billing cycle of each Xxxxxx. We will notify your electronic Xxxxxx(s) as to the change in status of your account and it is your sole responsibility to make arrangements for an alternative form of bill delivery. We will not be responsible for presenting any electronic bills that are already in process at the time of cancellation.

  • Personal Data Breach Notification SAP will notify Customer without undue delay after becoming aware of any Personal Data Breach and provide reasonable information in its possession to assist Customer to meet Customer’s obligations to report a Personal Data Breach as required under Data Protection Law. SAP may provide such information in phases as it becomes available. Such notification shall not be interpreted or construed as an admission of fault or liability by SAP.

  • Transfer to a safe job (a) Where an employee is pregnant and, in the opinion of a registered medical practitioner, illness or risks arising out of the pregnancy or hazards connected with the work assigned to the employee make it inadvisable for the employee to continue at her present work, the employee will, if the employer deems it practicable, be transferred to a safe job at the rate and on the conditions attaching to that job until the commencement of maternity leave.

  • Notification to Employer The Union shall notify the Employer of the names of the Employees, including the department wherein the Employee is employed, who are members of the Board of Directors, the Union Executive and Council Committees.

  • Notification of Subsequent Employer Prior to accepting employment with any other person or entity during any period during which Executive remains subject to any of the covenants set forth in Section 5.03 or Section 5.04, Executive shall provide such prospective employer with written notice of the provisions of this Agreement, with a copy of such notice delivered simultaneously to Employer in accordance with Section 6.05.

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