Data Safety Monitoring Committee Sample Clauses

Data Safety Monitoring Committee. ‌ At the interim analyses, primary efficacy outcome and/or safety outcomes will be reviewed by the DSMB to determine if the trial will be stopped for futility or efficacy or continue as planned (Section 9.5). The DSMB will meet at least three times during the course of the study. Enrollment will be paused for evaluation of safety and efficacy after the enrollment of the first 40 patients and the first meeting of the DSMB will occur within the first week of enrolling the 40th patient. No further patients will be enrolled until the completion of this DSMB review and the safety and efficacy data from the first 40 patients will be shared with the FDA prior to resuming enrollment. The remaining DSMB meetings are planned to evaluate the data from the IA. The DSMB may also meet at other times during the study as needed. The independent DSMB will be composed of at least 3 members who are independent of Karyopharm and the study. The DSMB will meet to evaluate safety and efficacy, to ensure the appropriate benefit risk profile for patients enrolled in the study and to review any SAEs that occur during the study. The DSMB will be provided with all reports of AEs including SAEs regardless of Investigator causality assessments. Details on how the DSMB will review safety and response data are provided in the DSMB Charter. The DSMB review will include, but not be limited to, evaluations of duration of therapy and all cause and AE-related dose reductions, interruptions, and discontinuations. At the interim analyses, primary efficacy outcome and selected safety outcomes will be reviewed by the DSMB to determine if the trial will be stopped for futility or efficacy or continue as planned.
Sample 1
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Related to Data Safety Monitoring Committee

  • Monitoring Committee The Monitoring Committee shall be established within six months of the signing of the Memorandum of Understanding. Its role is stipulated in the Regulation, in particular Article 4.4 thereof.

  • Joint Safety Committee (a) The Union and the Company shall cooperate in selecting one or more Safety Committees, which will meet at least once a month to consider all safety and occupational health problems.

  • Technical Advisory Committee (TAC The goal of this subtask is to create an advisory committee for this Agreement. The TAC should be composed of diverse professionals. The composition will vary depending on interest, availability, and need. TAC members will serve at the CAM’s discretion. The purpose of the TAC is to: • Provide guidance in project direction. The guidance may include scope and methodologies, timing, and coordination with other projects. The guidance may be based on: o Technical area expertise; o Knowledge of market applications; or o Linkages between the agreement work and other past, present, or future projects (both public and private sectors) that TAC members are aware of in a particular area. • Review products and provide recommendations for needed product adjustments, refinements, or enhancements. • Evaluate the tangible benefits of the project to the state of California, and provide recommendations as needed to enhance the benefits. • Provide recommendations regarding information dissemination, market pathways, or commercialization strategies relevant to the project products. The TAC may be composed of qualified professionals spanning the following types of disciplines: • Researchers knowledgeable about the project subject matter; • Members of trades that will apply the results of the project (e.g., designers, engineers, architects, contractors, and trade representatives); • Public interest market transformation implementers; • Product developers relevant to the project; • U.S. Department of Energy research managers, or experts from other federal or state agencies relevant to the project; • Public interest environmental groups; • Utility representatives; • Air district staff; and • Members of relevant technical society committees. The Recipient shall: • Prepare a List of Potential TAC Members that includes the names, companies, physical and electronic addresses, and phone numbers of potential members. The list will be discussed at the Kick-off meeting, and a schedule for recruiting members and holding the first TAC meeting will be developed. • Recruit TAC members. Ensure that each individual understands member obligations and the TAC meeting schedule developed in subtask 1.11. • Prepare a List of TAC Members once all TAC members have committed to serving on the TAC. • Submit Documentation of TAC Member Commitment (such as Letters of Acceptance) from each TAC member. Products: • List of Potential TAC Members • List of TAC Members • Documentation of TAC Member Commitment

  • Technical Committee 1. The Technical Committee shall comprise:

  • Local Safety Committee There shall be established in each department and/or principal place of employment (for example: institutions, hospitals, colleges, transportation department areas, Department of Natural Resources regions, etc.) a joint Safety Committee composed of Appointing Authority representatives selected by the Appointing Authority and employee representatives selected by the Union, one from each bargaining unit represented by the Union but at a minimum, a total of two (2) representatives. If more than one (1) exclusive representative exists in the department or principal place of employment, the Union will attempt to work out an arrangement with the other exclusive bargaining representative(s) to insure their input to the Committee. The chair of the Committee shall be appointed by the Appointing Authority. The Appointing Authority may consider having co-chairs, one management and one labor. The Safety Committee shall meet at least quarterly or as may be legally required and meetings shall be scheduled by the Safety Officer. Additional meetings may be called by the Safety Officer or by the Local Union or Appointing Authority as the need may arise. All Safety Committee meetings shall be held during normal day shift working hours on the Appointing Authority's premises and without loss of pay. The function of the Safety Committee will be to review reports of property damage and personal injury accidents and alleged hazardous working conditions, to provide support for a strong safety program, to review building security issues, and to review and recommend safety policies to the Appointing Authority. Normally, the Committee shall acknowledge in writing receipt of reports of alleged hazardous working conditions within thirty (30) calendar days of their submission. A copy of the Committee's recommendations, if any, to the Appointing Authority regarding the disposition of such reports shall also be provided to the individual who filed the report with the Committee. In addition, the Safety Committee will provide the filing party with a copy of the Appointing Authority's response and/or proposed actions, if any. At the request of the Local Union or Safety Committee, hazard assessments will be made available for review. Each Local Safety Committee in a facility with a laundry and/or a kitchen shall perform a routine heat survey to check temperature, humidity, and exhaust and fan systems in the laundries and kitchens. The Employer agrees to coordinate technical assistance to the Local Safety Committee upon request.

  • Staffing Committee A. Responsibilities. The Nurse Staffing Committee (“NSC”) shall be responsible for determining the Institute’s staffing plan and resolving complaints raised by nurses regarding the implementation of the plan as well as those activities required of it under RCW 70.41, et seq and its successors.

  • 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.

  • Project Management Plan 1 3.4.1 Developer is responsible for all quality assurance and quality control 2 activities necessary to manage the Work, including the Utility Adjustment Work.

  • Health & Safety Committee The Employer agrees to establish a Health & Safety Committee for all employees of the company under the auspices of the Occupational Health and Safety Act (OHSA). The Committee shall be made up of an equal number (not less than one each) of non-bargaining unit and bargaining unit persons who have completed their probationary period. The Union has the right to appoint the members representing the bargaining unit. The Committee shall keep minutes of its meetings and post them in the shop. One copy will be forwarded to the Union office.

  • PERFORMANCE MANAGEMENT SYSTEM 5.1 The Employee agrees to participate in the performance management system that the Employer adopts or introduces for the Employer, management and municipal staff of the Employer.

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