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: i. 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 [**] days after the IND sponsor’s receipt of the information, must be submitted to the COR within [**] of FDA notification. ii. 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 [**] day after the IND sponsor’s receipt of the information, must be submitted to the COR within [**] of FDA notification. iii. IDE reports of unanticipated adverse device effect: A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the COR within [**] of FDA notification. iv. Expedited safety reports: Sent to the COR concurrently with the report to FDA. v. Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported to the CO and the COR annually. In case of problems or issues, the Contracting Officer’s Representative will contact the Contractor within [**] working days by email or fax, followed within [**] calendar days by an official letter to the Contractor’s Project Manager, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed.
Sample 1See All (9)
AutoNDA by SimpleDocs
Required Time-Sensitive Notification. Under the contract, the Contractor must submit to the Contracting Officer’s representative (COR) as follows: 1. 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 days after the IND sponsor’s receipt of the information, must be submitted within 24 hours of knowledge of the event by the Contractor.
Sample 1Sample 2
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:
Sample 1Sample 2
Required Time-Sensitive Notification. Under an 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: a. IDE reports of unanticipated adverse device effect: A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the COR within [***] of FDA notification. b. Expedited safety reports: Sent to the COR concurrently with the report to FDA. c. Other adverse events documented during the course of the trial should be included in the annual IDE report and reported to BARDA annually. In case of problems or issues, the Contracting Officer’s Representative will contact the Contractor within [***] by email or fax, followed within [***] by an official letter to the Contractor’s Project Manager, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed. d. Safety reporting for research not performed under an IDE. Final decisions regarding ongoing safety reporting requirements for research not performed under an IDE must be made jointly by the COR and the Contractor.
Sample 1

Related to Required Time-Sensitive Notification

  • 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. B. Contractor must notify HHSC of any confirmed or suspected unauthorized acquisition, access, use or disclosure of sensitive personal information related to this Contract, including any breach of system security, as section 521.053 of the Business and Commerce Code defines that phrase. Contractor must submit a written report to HHSC as soon as possible but no later than 10 business days after discovering the unauthorized acquisition, access, use or disclosure. The written report must identify everyone whose sensitive personal information has been or is reasonably believed to have been compromised. C. Contractor must either disclose the unauthorized acquisition, access, use or disclosure to everyone whose sensitive personal information has been or is reasonably believed to have been compromised or pay the expenses associated with HHSC doing the disclosure if: 1. Contractor experiences a breach of system security involving information owned by HHSC for which disclosure or notification is required under section 521.053 of the Business and Commerce Code; or 2. Contractor experiences a breach of unsecured protected health information, as 45 C.F.R. §164.402 defines that phrase, and HHSC becomes responsible for doing the notification required by 45 C.F.R. §164.404. HHSC may, at its discretion, waive Contractor's payment of expenses associated with HHSC doing the disclosure.

  • Notification of Absence A unit member shall contact the office of the division xxxx whenever there is a need to be absent and at least thirty (30) minutes prior to missing any work assignment. Should circumstances prohibit this notification, the unit member shall notify the division office in writing, within one week of returning to work, providing the reasons why advance notification was not given.

  • 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. (b) If the transfer to a safe job is not practicable, the employee may elect, or the employer may require the employee to commence parental leave for such period as is certified necessary by a registered medical practitioner.

  • Required Notifications Each Grantor shall promptly notify the Administrative Agent, in writing, of: (i) any Lien (other than Permitted Liens) on any of the Collateral which would adversely affect the ability of the Administrative Agent to exercise any of its remedies hereunder and (ii) the occurrence of any other event which could reasonably be expected to have a material impairment on the aggregate value of the Collateral or on the security interests created hereby.

  • 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 Executive hereby agrees that prior to accepting employment with, or agreeing to provide services to, any other Person during any period during which Executive remains subject to any of the covenants set forth in Section 5, Executive shall provide such prospective employer with written notice of such provisions of this Agreement, with a copy of such notice delivered simultaneously to the Company.

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