Data and Safety Monitoring Board Sample Clauses

Data and Safety Monitoring Board an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. The Government retains the right to place a nonvoting member on the DSMB. When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by the Government before enrollment starts. Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the Government within 30 days of reviews or meetings.
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Data and Safety Monitoring Board. To ensure that appropriate ethical consideration is given to the welfare of the patients enrolled in the study, NINDS-NIH has appointed a Data and Safety Monitoring Board (DSMB) to oversee the trial. The DSMB will review the incidences and circumstances of adverse events that occur during the course of the trial. Formal interim analyses will occur after 25%, 50%, and 75% of patients have been enrolled. The members of the DSMB are: Xxxxx Xxxxxxx, MD (Chair) - Professor and Chair of Neurology, University of Texas, San Antonio, Stroke Neurologist Xxxxx Xxxxxxxx, MD - Associate Professor of Neurology and Health Evaluation Sciences, University of Virginia, Stroke Neurologist and Health Outcomes Specialist Xxxxxx Xxxxxx, MD - Assistant Professor of Neurology, Xxxx Xxxxxxx, Stroke Neurologist Xxxxx Xxxxxxxxx, MD - Associate Professor of Neurology, University of Texas, San Antonio, Stroke Neurologist Xxxxxxx Xxxxxx, PhD - Professor of Biomathematics, University of Iowa, Statistician
Sample 1
Data and Safety Monitoring Board. (DSMB) & Ethical Advisory board The DSMB will ensure a high standard of research and monitor all safety aspects of the trial and will also check for the progress of the Project by having their own bi-annual DSMB meetings and also by taking part in the annual General Assembly meetings. Safety assessment mainly includes bleeding, occurrence of stroke and the primary outcome with respect to mortality and severe renal failure. In addition, the DSMB will critically assess the results of the interim analysis for the primary study end- point as well as for safety endpoints. For the primary study endpoint the study will be halted based on the predefined statistical analysis plan. Whenever appropriate, it will consult the consortium and make recommendations as to improve their performance and also to adjust the trial protocol or to halt the trial after the first interim analysis. The DSMB will also serve as ethical advisory board. Ethi- cal Advisory board oversees all ethical issues, implements the ethical follow-up of the Project (see Section 6.8).
Sample 1
Data and Safety Monitoring Board. A duly constituted Data and Safety Monitoring Board (hereinafter DSMB) has the authority and responsibility to review accumulating data from clinical investigations conducted at NIDA. The clinical investigation that is the subject of this Agreement shall be reviewed by the DSMB. The DSMB will meet on a regular basis and will review safety and efficacy data. The Principal Investigators must report all adverse drug experiences regardless of severity and must present a brief progress statement on the Study to each regularly scheduled meeting of the DSMB. The progress statement should contain an assurance that there is no evidence of safety or toxicity issues that should be addressed by the DSMB. The DSMB shall report early evidence of pre-specified or unanticipated benefit or harm to participants in the trial that may be attributable to the Agent or the treatments under evaluation in the clinical investigation. The DSMB shall conduct an independent, objective review of all accumulated data in such a manner as to maximize the benefits to the trial participants and to the research effort. The DSMB shall consider whether or not a Protocol modification is indicated based on this review, and the DSMB shall advise NIDA on the appropriateness of continuing the Study as designed. It is understood and agreed that NIDA and Collaborator shall provide clinical trial data to the DSMB, in the format specified by the DSMB, three (3) weeks prior to the meeting dates established and specified by the DSMB. It is further understood and agreed that NIDA will format the data for submission to the DSMB through the statistical center contracted by NIDA, as supplied by participating clinical trial sites on a schedule to be specified by the statistical center. It is further understood and agreed that both Collaborator and NIDA will have key trial personnel available to meet with the DSMB and provide information, if so requested, and agree to abide by final decisions of the DSMB.
Sample 1

Related to Data and Safety Monitoring Board

  • Health and Safety Committees A. The parties agree that Joint Union/Management Health and Safety Committees are appropriate. At the Union's request, each department shall establish at least one Joint Union/Management Health and Safety Committee.

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

  • Health and Safety Committee Where required a committee will be formed and will meet where required by the Employer’s safety policies and by statute.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

  • Accident Prevention Health and Safety Committee The Employer and the Union agree that they mutually desire to maintain standards of safety and health in the Hospital in order to prevent accidents, in jury and illness. its responsibilities under the applicable legislation, the agrees to accept as a member of its Accident Prevention Health 6 Safety Committee at l e a s t one representative selected or appointed by the Union from amongst bargaining unit employees. shall identify potential dangers and hazards, institute means of improving health and programs and recommend to be a e improve related and health. The Hospital agrees to co-operate i providing information to enable the Committee to its function. shall i be at the call of Chair if shall minutes O f all meetings t h e s a m e available for representative o r selected accordance with shall serve for a of one calendar year the date of appointment which may renewed for further periods of one year. off for such to attend meetings of the Accident Prevention and Safety Committee accordance with shall and spent s h a l l be deemed to b e work time for which the representative(s) shall be paid by the a t his/her regular or premium rate as m a y be applicable. ARTICLE PAID The Holidays with pay for this Agreement shall be: New's Years Day Good Friday Easter Monday Victoria Day Dominion Da) Holiday (as locally declared) During of this the Day, which is not a day, shall be granted third in If a that shall replace this holiday. t the nature of services necessary a Hospital, of the e m p l o y e e s ma be required work these In general, may required alternate with other in absent instance, an e m p l o y e e having Day off 0 be off on Year's Day. a the preference. To qualify for holiday pay as above, an employee must work his or her full regularly scheduled shift immediately preceding and his or her full regularly scheduled shift immediately succeeding the Holiday. In the event of an employee being prevented from working the shift immediately preceding and/or succeeding such holiday by reason of illness, authenticated by medical certificate or otherwise, lasting more than five full working such employee shall qualify for holiday pay, it being further understood and agreed that no employee shall receive holiday pay for more than one holiday during any one illness except for holidays over the Christmas and Year's periods, in which case no employee shall receive pay for more than three holidays. of the above named holidays an regular day off, or during his or her vacation the employee receive off payment for holidays in lieu thereof, but additional shall not be added to the period of vacation of employee except the of the Department his work shall time half time rate of o r . such in addition any entitled or at the option of the the employee may be paid time one half for the time worked and a paid day off in lieu thereof, or, (or a further option of the Hospital), the employee may be paid his regular straight time plus a paid clay and a half off in lieu thereof. Failure report for work assigned on such holiday shall disqualify employee for holiday pay.

  • Occupational Health and Safety Committee The Employer and the Union agree to cooperate in the promotion of safe working conditions, the prevention of accidents, the prevention of workplace injuries and the promotion of safe workplace practices.

  • Health and Safety Plan 5. Xxxxxx shall prepare and submit under separate cover from the Work Plan, a Health and Safety Plan consistent with Occupational Safety and Health Administration regulations. The Health and Safety Plan shall be submitted to the Department in the form of one electronic copy on compact disk (in .pdf format). Xxxxxx agrees that the Health and Safety Plan is submitted to the Department only for informational purposes. The Department expressly disclaims any liability that may result from implementation of the Health and Safety Plan by Xxxxxx. PUBLIC PARTICIPATION

  • Joint Health and Safety Committee i) Recognizing its responsibilities under the applicable legislation, the Hospital agrees to accept as a member of its Joint Health and Safety Committee, at least one (1) representative selected or appointed by the Association from amongst bargaining unit employees from each Hospital site. Hospitals will choose either to include a representative from the bargaining unit from each Hospital site, or to have a separate Joint Health and Safety Committee at each Hospital site, unless the parties agree otherwise.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

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