Emergency Unblinding Sample Clauses

Emergency Unblinding. ‌ The treatment assignment of any individual subject may be accessed only in case of an emergency, such as a life-threatening serious adverse event (SAE) where knowledge of the treatment code is required for medical management of the event. The investigator should obtain approval from the medical monitor or sponsor prior to unblinding and should document the unblinding (including notification of sponsor/medical monitor and reason for unblinding) in the subject’s medical record. Contact information for notification of unblinding: PRA Oncology Call Center Toll Free: +0 (000) 000-0000 Direct: +0 (000) 000-0000 Fax: +0 (000) 000-0000 Email: xxxxxx@xxxxxxx.xxx After obtaining sponsor or medical monitor approval, to unblind the subject’s treatment assignment the investigator will log into IXRS and enter, at minimum, the subject’s randomization number; IXRS will then provide the treatment assignment. The treatment assignment should be maintained as confidential (i.e., only personnel essential for subject treatment should be informed of the treatment assigned) and placed in a sealed envelope. The treatment code for an individual subject may also be broken at the discretion of the study sponsor to facilitate regulatory reporting of suspected unexpected serious adverse reactions (SUSAR).
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Emergency Unblinding. During the study, the blind is to be broken by the investigator via the IRT system only when the safety of a participant is at risk and the treatment plan is dependent on the study treatment received. Unless a participant is at immediate risk, the investigator should make attempts to contact Sage prior to unblinding the study treatment administered to a participant. The responsibility to break the treatment code in emergency situations resides solely with the investigator. If the unblinding occurs without Xxxx’s knowledge, the investigator must notify Sage within 24 hours of breaking the blind. All circumstances surrounding a premature unblinding must be clearly documented in the source records. In all cases where the IP allocation for a participant is unblinded, pertinent information (including the reason for unblinding) must be documented in the participant’s records and on the eCRF. At the time of withdrawal from the study/stopping participation, if possible, an EOT and/or ET visit should be conducted.

Related to Emergency Unblinding

  • Emergency Use In the case of any civil emergency or disaster, the Licensee shall, upon request of the Issuing Authority, make available to the Town a channel for use during the civil emergency or disaster period. The Licensee shall adhere to any new Emergency notification standards as established by the Federal Communications Commission.

  • Accident Prevention Health and Safety Committee The Employer and the Union agree that they mutually to maintain standards of safety and health in the Hospital in order to prevent accidents, injury, and illness. ected or Recognizing its responsibilities under the applicable legislation, the Hospital agrees to accept as a member of its Accident Prevention Health and Safety Committee, at least one (1) representative sel appointed by the Union from amongst Bargaining Unit employees. Such Committee shall identify potential dangers and means of improving health and safety programs, and recommend actions to be taken to improve conditions related to safety and health. The Hospital agrees to co-operate reasonably in providing necessary information to enable the Committee its functions. Meetings shall be held every second month or more frequently at the call of the Chair if required. The Committee shall maintain minutes of meetings and make the Same available for review. Any representative appointed or accordancewith hereof shall serve for a term of one (1) calendar year from the date of appointment which may be renewed for further of one (1) year. Time off for such to attend meetings of the Accident Prevention Health and Safety Committee in accordance with the foregoing shall be granted, and any attending such meetings during their regularly scheduled hours of work shall not lose regular as a result of such The Union agrees to endeavour to obtain the membership in the observation of all safety rules and practices. Safety Shoes The Hospital will provide sixty dollars ($60.00) annually effective April and eighty dollars ($80.00) effective April to each employee who is required by the Hospital, as delineated below, to wear safety footwear during the of his duties. The Hospital will require employees the following functions to wear appropriate Engineering Services; Grounds; Transport; (only where frequently working in storage areas). (as determined by the Hospital) heavy carts on a regular basis, e.g., linen carts, food wagons. ARTICLE BULLETIN BOARDS The Employer shall provide bulletin that all employees will have access to them have the right to post notices of meetings and such other notices as may be of interest to the membership. The wage increase listed on a retroactive to contact,in writing (with a copy to the Union) at their last-known entitle who have left its employ, to advise them of their any retroactive wage adjustment. Any employees who have employees shall have notice from the Hospital in which to claim from the Hospital any adjustment to their remuneration entitlement. The retroactive payments shall be made by separate cheques to the employees so entitled within sixty (60) days from the date of ratification. All other adjustments shall be effective as set out specifically in this Collective Agreement.

  • DISASTER OR EMERGENCY REPORTS Any disaster or emergency situation, natural or man-made, such as fire or severe weather, shall be reported telephonically within 72 hours, followed by a comprehensive written report within seven days to DHA.

  • Emergency Childcare Employees may use vacation leave for childcare emergencies after the employee has exhausted all of their accrued compensatory time. Use of vacation leave and sick leave for emergency childcare is limited to a combined maximum of four (4) days per calendar year.

  • Emergency Medical Care a. How to appropriately use Emergency Services and facilities, including a description of the services offered by the Member Services Call Center;

  • Emergency Calls IP Phones need an additional power supply to operate. In the event of a power failure it is your responsibility to ensure you have the means to make emergency calls. In accordance with paragraph 13.2, we will not be liable for any loss or damage (financial or otherwise) where you fail to do so.

  • Emergency Medical Condition A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in any of the following: (1) placing the health of the individual (or with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; (2) serious impairment to body functions; or (3) serious dysfunction of any body organ or part.

  • Joint Occupational Health and Safety Committee The Employer and the Union recognize the role of the joint Occupational Health and Safety Committee in promoting a safe and healthful workplace. The parties agree that a Joint Occupational Health and Safety Committee shall be established for each Employer covered by this Collective Agreement. The Committee shall govern itself in accordance with the provisions of the Industrial Health and Safety Regulations made pursuant to the Workers’ Compensation Act. The Committee shall be as between the Employer and the Union, with equal representation, and with each party appointing its own representatives. Representatives of the Union shall be chosen by the Union membership or appointed by the Union. All minutes of the meetings of the Joint Occupational Health & Safety Committee will be recorded in a mutually agreeable format and will be sent to the Union. The Union further agrees to actively pursue with the other Health Care Unions a Joint Union Committee for the purposes of this Article. The Employer agrees to provide or cause to be provided to Employer members of the Joint Occupational Health and Safety Committee adequate training and orientation to the duties and responsibilities of committee members to allow the incumbents to fulfil those duties competently. The Union agrees to provide or cause to be provided to Union members of the Joint Occupational Health and Safety Committee adequate training and orientation to the duties and responsibilities of committee members to allow the incumbents to fulfil those duties competently. Such training and orientation shall take place within six (6) months of taking office.

  • Emergency Closures A. The University’s inability to make a Room available to me for any reason beyond the University’s control including, but not limited to, natural disaster, fire, flood, earthquake, condemnation, pandemic, quarantine, utility malfunction, infestation, or other emergency or force majeure event shall not constitute a breach of this Agreement by the University. In such circumstances, the University shall have no liability to me in any way for injuries, reimbursement, damages, inconvenience, annoyance or compensation of any kind. The University may attempt to find, but cannot guarantee, an alternative space for me. If the unavailability of my Room or an alternative space persists for more than 72 hours, I may terminate this Agreement and Check out during said unavailability without penalty provided that I shall be responsible for all financial obligations incurred up to the date of such termination. The University agrees to provide me with a pro rata refund, calculated from the date of such termination to the end of the Agreement Period, of any prepaid housing and dining payment made to the University, and to return my Deposit pursuant to this Agreement. Upon resumption of standard operations, Agreement Termination requirements and charges will apply as described in Section XIV.

  • Medical Care and Emergency Leave An employee is entitled to a leave of absence without pay because of any of the following:

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