Safety Endpoint Sample Clauses

Safety Endpoint. ‌ Evaluation of the short- and long-term adverse events profile of the EBV Treatment arm during the treatment period, defined as the day of the study procedure until 45 days after the study procedure (short), and in the post-treatment period, defined as 46 days after the study procedure until the 1-year follow-up visit (long).
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Safety Endpoint. ‌ Safety will be determined by evaluating the adverse events profile for the EBV Treatment Group for 1) the shorter-term treatment period, defined as the day of the study procedure until 45 days after the study procedure (‘short’) and 2) the longer-term post-treatment period, defined as 46 days after the study procedure until the 1 year follow-up visit (‘long’).
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Safety Endpoint. Evaluation of the short- and long-term adverse events profile of the EBV treatment arm during the treatment period, defined as the day of the study procedure until 45 days after the study procedure (short), and in the post-treatment period, defined as 46 days after the study procedure until the 1-year follow-up visit (long). Additional Measures • Spirometry, including FEV1, forced vital capacity (FVC) and the ratio of FEV1/FVC • Body plethysmography, including residual volume (RV), inspiratory capacity (IC), functional residual capacity (FRC),TLC, and the ratios of RV/TLC and IC/TLC • SGRQ global and domain (ie. ‘symptoms’, ‘activity’ and ‘impacts on daily life’) scores • Modified Medical Research Council (mMRC) Dyspnea Scale Score • BODE Index • Transitional Dyspnea Index (TDI) from Baseline Dyspnea Index (BDI) • COPD Assessment Test (CAT) • SF-36 Health Survey score • EQ-5D Health Survey score • Health Care Utilization Questionnaire • 6MWD test • Borg scale dyspnea scores before and after 6MWD test • Change in use of ‘maintenance’ medications, including bronchodilators, corticosteroids, antibiotics, and anti-inflammatories • Pulmonary rehabilitation compliance diary responses • EXACT-PRO diary responses • Health status change responses • Carbon Monoxide Diffusing Capacity (DLCO) • Lung radiographic features Interim Analysis An interim data analysis designed to evaluate effectiveness for continuing crossover of control arm study participants at 1 year to EBV treatment will be performed when 74 (50% of the total 147) study participants have completed the 1 year follow-up. The interim analysis will be reviewed by the DSMB and FDA. If crossover of control arm study participants is found to be justified by the interim analysis, then crossover of control arm study participants may be continued. If the DSMB recommends not continuing crossing control arm participants to EBV treatment, then those control arm patients who have not yet crossed over will exit from the study per protocol after the 1-year visit. Long-Term Follow-up Data will be collected annually through 5 years. Per the regulatory plan agreed to with FDA, 1 year of follow-up is required pre-approval and the remaining 4 years will be conducted post- approval. The 2-, 3-, 4-, and 5-year data will consist of FEV1 and adverse events.
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Related to Safety Endpoint

  • Safety Boots Each employee, after 3 months’ continuous service, will be reimbursed (on production of a receipt), the cost of one pair of safety boots (approved by the employer), in each year, to a maximum of $110.00. Wet Weather All protective clothing such as wet weather jackets, safety helmets, welding jackets, welding xxxxxxx, welding gauntlets, rubber boots, etc, (which remain the property of the Company), will be supplied on all occasions deemed necessary.

  • Safety Orientation All employees shall be certified in Safety Orientation. Safety Orientation shall consist of three parts: PART 1 - the CODC Interactive Rights and Responsibilities course; PART 2 - the XXXX course or equivalent, and PART 3 - Employer or Owner Project Specific Training. It is the responsibility of each employee to hold current certification and maintain certification in part 1 and Part 2. The Employer or Owner shall provide to each Employee before commencing work with PART 3 - Employer or Owner Project Specific Training. Each Employee shall be on the payroll and paid while receiving PART 3 training. As a condition of employment it is the sole responsibility of each and every employee to obtain, hold and maintain all current certification(s) in any and all legislated safety training requirements (i.e. WHMIS, Fall Arrest, etc.) that are trade specific. Supporting documentation of all legislated training must be provided by the employee to the Union prior to dispatch and to the employer upon hire and may be further requested by the employer at any time during the duration of their employment. Prior to the expiration of any certification, the Employer will notify the Employee of the pending expiration and give the Employee reasonable time to renew their certification. Further, prior to arriving at site, employees shall hold current qualification(s) for the specific tasks and equipment identified in the dispatch request. If the employee has to be trained after dispatch, all costs borne by the Employer shall be reimbursed by the Training Fund. The CODC Harassment Policy and Procedures, including the provisions regarding General Harassment and as amended from time to time shall be the minimum standard of this Agreement.

  • Safety Glasses 10.3.1 Where a teacher is considered to be working in an “eye danger” area, the teacher shall receive a personal issue of standard neutral safety glasses which shall remain the property of the employer.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Safety Footwear 1. The State will provide employees in the classifications listed in Section 7 below, and employees who are currently required to wear safety footwear by Department Work Rules, an allowance of one hundred twenty dollars ($120.00) for replacement of safety footwear.

  • SAFETY & HEALTH The Employer and the IBTCoalition agree that the safety of employees and the general public is of utmost importance. Therefore, the Employer shall provide a safe work environment that is free of recognized hazards that could cause death, injury or illness.

  • Safety Program The Contractor shall design a specific safety program for the Work for the site(s). The Contractor shall establish and require all Subcontractors to establish reasonable safety programs. The Contractor shall also submit its standard monthly safety reports to the Owner and Design Professional. No imposition of responsibility on the Contractor for safety under this Contract shall relieve any subcontractor of its responsibility for safety of persons or property on or near the Project Site. The Contractor shall include in his plant he names of the person in charge of Safety.

  • MATERIAL SAFETY DATA SHEETS Contractor is required to ensure Material Safety Data Sheets (“MSDS”) are available, employees are trained in the use of MSDS, and MSDS are in a readily accessible place at the Site. This requirement applies to all materials with an associated MSDS per the federal “Hazard Communication” standard or employees’ Right-to-Know laws. Contractor is also required to ensure proper labeling and training on any substance brought onto the Site and that any person working with the material (or who is subject to possible exposure by use of the material or contact with the material), is informed of the possible and/or real hazards of the substance, and follows proper handling and protection procedures.

  • Material Safety Data Sheet Seller shall provide to Buyer with each delivery any Material Safety Data Sheet applicable to the work in conformance with and containing such information as required by the Occupational Safety and Health Act of 1970 and regulations promulgated thereunder or its State approved counterpart.

  • Safety Data Sheets If specified by City in the solicitation or otherwise required by this Contract, Contractor must send with each shipment one (1) copy of the Safety Data Sheet (SDS) for each item shipped. Failure to comply with this procedure will be cause for immediate termination of the Contract for violation of safety procedures.

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