Data and Safety Monitoring Board Clause Samples

The Data and Safety Monitoring Board (DSMB) clause establishes an independent committee responsible for overseeing the safety and integrity of a clinical trial or research study. This board typically reviews accumulating data at regular intervals, monitors for adverse events, and can recommend modifications or early termination of the study if participant safety is at risk. The core function of this clause is to ensure ongoing, unbiased oversight to protect participants and maintain the credibility of the research.
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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. This award is subject to the NIDA Guidelines for Establishing and Operating a Data and Safety Monitoring Board.
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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: ▇▇▇▇▇ ▇▇▇▇▇▇▇, MD (Chair) - Professor and Chair of Neurology, University of Texas, San Antonio, Stroke Neurologist ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, MD - Associate Professor of Neurology and Health Evaluation Sciences, University of Virginia, Stroke Neurologist and Health Outcomes Specialist ▇▇▇▇▇▇ ▇▇▇▇▇▇, MD - Assistant Professor of Neurology, ▇▇▇▇ ▇▇▇▇▇▇▇, Stroke Neurologist ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, MD - Associate Professor of Neurology, University of Texas, San Antonio, Stroke Neurologist ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, PhD - Professor of Biomathematics, University of Iowa, Statistician
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Data and Safety Monitoring Board. (DSMB) & Ethical Advisory board
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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.
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Related to Data and Safety Monitoring Board

  • Health and Safety Committees In order to provide a safe and healthful workplace, local unit level LMCs shall establish Health and Safety Committees. Each committee will be composed of an equal number of representatives appointed by the Union and the Employer and will be co-chaired by a Union and Employer representative. A Union representative must be a member of the unit but either party may be accompanied by staff and/or other subject matter experts who may participate, but not vote, at meetings. Each party shall prepare and submit an agenda to the other party one week prior to any scheduled meeting. If neither party submits an agenda, the meeting shall be canceled. Each committee’s general responsibility will be to provide a safe and healthful workplace by recognizing hazards and recommending the abatement of hazards and educational programs. Each committee will: 1. meet on an established schedule; 2. arrange periodic inspections to detect, evaluate and offer recommendations for control of potential health and safety hazards; 3. appoint members of the committee to participate in inspections, investigations, or other established health and safety functions to the extent necessary; 4. receive and review a quarterly summary of job-related health and safety reports including accident reports and make appropriate recommendations; 5. investigate all types of employee job-related accidents and all types of occupational illnesses and make recommendations; 6. promote health and safety education; 7. study the use of VDTs and make appropriate recommendations to ensure the health and safety of employees regarding such use; 8. maintain and review minutes of all committee meetings; and 9. review the availability and adequacy of first aid supplies and equipment and address any inadequacies. In cases where summary reports are provided, a committee member may request and receive an individual case file or report. In no case will an employee’s records be provided when the law forbids disclosure. In addition, employees’ names will normally be deleted but may be provided to all committee members in instances where committee members need to know the name(s) of employee(s) to effectively represent the bargaining unit(s) and disclosure of name(s) is not prohibited by law. The Employer may require committee members and Union representatives to sign confidentiality statements. Members of each Health and Safety Committee will be paid by the Employer while performing committee duties, including travel time, and will also be paid for any time spent in committee approved training related to health and safety. The Committee will develop an annual training program for its members. Each Health and Safety Committee will establish rules consistent with the above principles. A mechanism to coordinate the efforts of individual Health and Safety Committees will be established at each agency.

  • 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 (a) The Company and the Union agree that they mutually desire to maintain standards of safety and health in the Company in order to prevent accidents, injury and illness. (b) Recognizing its responsibilities under the applicable legislation, the Company agrees to accept as a member of its Accident Prevention Health and Safety Committee at least one representative selected or appointed by the Union from amongst bargaining unit employees. (c) Such Committee shall identify potential dangers and hazards, institute means of improving health and safety programs and recommend actions to be taken to improve conditions related to safety and health. (d) The Company agrees to cooperate reasonably in providing necessary information to enable the Committee to fulfil its functions. (e) Meetings shall be held every second month or more frequently at the call of the chair if required. The Committee shall maintain minutes of all meetings and make the same available for review. (f) Any representative appointed or selected in accordance with (b) hereof shall serve for a term of one calendar year from the date of appointment which may be renewed for further periods of one year. Time off for such representative(s) to attend meetings of the Accident Prevention Health and Safety Committee in accordance with the foregoing shall be granted and time so spent attending such meetings shall be deemed to be work time for which the representative(s) shall be paid by the Company at his regular or premium rate as may be applicable. (g) The Union agrees to endeavour to obtain the full cooperation of its membership in the observation of all safety rules and practices. (h) Pregnant employees may request to be transferred from their current duties if, in the professional opinion of the employee's physician, the pregnancy may be at risk. If such a transfer is not feasible, the pregnant employee, if she so requests, will be granted an unpaid leave of absence before commencement of the maternity leave referred to in Article 15.04. (i) Where the Company identifies high-risk areas where employees are exposed to Hepatitis B, the Company will provide, at no cost to the employees, a Hepatitis B vaccine. (j) The Company will recognize April 28 as the annual day of remembrance for workers killed, injured or have contracted a work related disease on the job. Subject to the requirements of patient care, the Company agrees to stop work and provide a minute of silence for all employees at 11:00 A.M. April 28, in memory of workers killed or injured on the job. The Company will announce on its public address system at 11:00 a.m., April 28 that all employees will be observing a minute of silence in memory of workers killed or injured in the job.