Data and Safety Monitoring Sample Clauses

Data and Safety Monitoring. Sponsor acknowledges that is has the responsibility to conduct data and safety monitoring. Monitoring will be performed on a regular basis, and conclusions of the Data and Safety monitoring entity reported to the Institution. Recommendations that emanate from monitoring activities will be reviewed by Sponsor and addressed. Sponsor assumes responsibility for informing Institution concerning the data and safety monitoring policy and procedures. Institution will provide feedback to Sponsor on a regular basis, including findings from adverse-event reports, and recommendations derived from data and safety monitoring. Notification of Results Sponsor shall promptly report to Institution any findings from monitoring or safety reporting of this Study or studies using the same or similar Study Drug / Device or treatment regimen, whether ongoing or ended, that could:
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Data and Safety Monitoring. The Sponsor acknowledges that it has the responsibility to conduct data and safety monitoring that will be performed on a regular basis with its conclusions reported to the Institution. Recommendations emanating from these monitoring activities will be reviewed by the Sponsor and addressed. The Sponsor assumes responsibility for informing the Institution concerning the data and safety monitoring policy and procedures. The Institution will provide feedback to the Sponsor on a regular basis, including findings from adverse-event reports and recommendations derived from data and safety monitoring. During a for a period of three [3] years after the Study, Sponsor shall promptly report to Institution any findings from monitoring or safety reporting of this Study or studies using the same or similar Study Drug/Device or treatment regimen, whether ongoing or ended, that could: Affect the safety of Study Subjects; affect Study Subjects' willingness to continue participation in the Study; influence the conduct of the research; or alter the IRB's approval to continue the Study The Sponsor acknowledges and agrees that the Institution may communicate any of the aforementioned findings to both current and former Study Subjects, as well as any participants in Studies using the same or similar Study Drug/Device or treatment regimen. No party shall be liable for any failure to perform its obligations, either temporarily or permanently, in connection with any action described in this Agreement, if such failure results from any act of God, riot, war, civil unrest, flood, earthquake, or other cause beyond such party’s reasonable control (including any mechanical, electronic, or communications failure, but excluding failure caused by a party’s financial condition or negligence).
Data and Safety Monitoring. Subawardee agrees to comply with NIH requirements for data and safety monitoring outlined in the NIH Grants Policy Statement.
Data and Safety Monitoring. The principal and research coordinator of this protocol will monitor data and safety regularly at weekly meetings. These meetings are separate from regular clinical rounds and consist of review of all study patients including flow sheets of major safety and efficacy measurements. The rationale for not using an outside data and safety monitoring committee is that this is a small, single center study using a medication that has been associated with few severe side effects. All measurements and tests are well established in clinical medicine. Yearly reports are made to the UCSD IRB regarding safety and efficacy. All serious adverse events will be reported to the UCSD IRB and Galmed Pharmaceuticals within 7 days. Unexpected and related fatal or life-threatening events will be reported within 48 hours and reports will be sent to the FDA, MEDWATCH program (telephone 1-000-XXX-0000; or via the Internet at wxx.xxx.xxx/xxxxxxxx/xxxxx.xxxx and Galmed Pharmaceuticals. All consents will be stored in well-marked binders in locked file cabinets located in private offices at UCSD Medical center. Databases with identifying information will be secure as they will be password protected and encrypted. Staff will be trained in HIPPA guidelines and confidentiality issues. All data and study forms will be in secured locations (locked room or cabinet) and access is limited to study personnel. Subject names are not used; instead a name code is assigned upon enrollment. Release of data to persons or organizations outside study personnel will require written consent of the subject.

Related to Data and Safety Monitoring

  • Child Safety BCHS values children from all backgrounds and is committed to making our community a safe, nurturing and welcoming place for children to grow and develop. We are committed to making sure ALL children reach their individual potential.

  • Fire Safety Resident will not tamper with fire alarms, smoke detectors, fire extinguishers, fire hoses, or exit signs. Resident will promptly evacuate Residence Facility upon the sounding of an alarm or as otherwise directed by College Housing staff. Resident will participate in any periodic fire drill and fire safety training conducted by College for the Residence Facility.

  • Health and Safety Plan Consultant shall prepare and submit a Health and Safety Plan (“HASP”) for the portion of Consultant’s work that will involve field work, assessments, or investigations of certain Project elements. The HASP shall describe how Consultant plans to complete field work, assessments, and/or investigations at the RWF. Consultant’s HASP must comply with the CIP HASP and shall be updated as new conditions are encountered.

  • Work Health and Safety (a) The employer and employee acknowledge their responsibilities under the Work Health and Safety Act 2011 and Work Health and Safety Regulations 2012. (b) Where there is a Work Health and Safety Representative they must be elected and will carry out the tasks associated with the role of Work Health and Safety Representative set out within the Work Health and Safety Act 2011.

  • Environmental Health and Safety i. Environment, Health and Safety Performance. Seller acknowledges and accepts full and sole responsibility to maintain an environment, health and safety management system ("EMS") appropriate for its business throughout the performance of this Contract. Buyer expects that Seller’s EMS shall promote health and safety, environmental stewardship, and pollution prevention by appropriate source reduction strategies. Seller shall convey the requirement of this clause to its suppliers. Seller shall not deliver goods that contain asbestos mineral fibers.

  • Environment, Health, and Safety (a) To the Knowledge of AIDEA and the Acquired Companies, except as disclosed in Disclosure Schedules 3.16(b), (d), and (e), the Acquired Companies have complied with all Environmental, Health, and Safety Laws. No action, suit, proceeding, hearing, investigation, charge, complaint, claim, demand, or notice has been filed or commenced against any of the Acquired Companies alleging any failure to so comply. Without limiting the generality of the preceding sentence, the Acquired Companies, to the Knowledge of AIDEA and the Acquired Companies, have obtained and been in compliance with all of the terms and conditions of all permits, licenses, and other authorizations that are required under, and have complied with all other limitations, restrictions, conditions, standards, prohibitions, requirements, obligations, schedules, and timetables that are contained in, all Environmental, Health, and Safety Laws. (b) Except as disclosed in Disclosure Schedule 3.16(b), neither the Acquired Companies nor AIDEA with respect to the Acquired Companies, to the Knowledge of AIDEA and the Acquired Companies, has any Liability arising out of events or circumstances occurring under any Environmental, Health, and Safety Laws for contamination of, damage to, or polluting any site, location, property, natural resources, the air, or any body of water (surface or subsurface), or for any illness of, or personal injury to, or death of, any employee or other individual related to the foregoing. (c) To the Knowledge of AIDEA and the Acquired Companies, all equipment and personal property owned, leased, or used in the Operations are and have been free of hydrocarbon contamination, asbestos, PCBs, dioxins, and any other hazardous, toxic, radioactive, or dangerous substances, except for the liquefied natural gas and compressed natural gas the Acquired Companies produce, store, and handle, and except for the fuel, lubricants, refrigerants, and solvents that are used in the ordinary course of business in conducting the Operations. The liquefied natural gas and compressed natural gas of the Acquired Companies, and the fuel, lubricants, refrigerants, and solvents used in its Operations, have all been stored, handled, transported, used, and disposed of in accordance with all Environmental, Health, and Safety Laws and consistent with all standard industry practices. (d) Except as disclosed on Disclosure Schedule 3.16(d), all real property the Acquired Companies owns is, to the Knowledge of AIDEA and the Acquired Companies, free from contamination by any substance regulated under, or defined as or considered “hazardous” or “toxic” or “radioactive” or “contamination” or “pollution” under, any Environmental, Health, and Safety Laws, including but not limited to hydrocarbons, asbestos, PCBs, and dioxins. AIDEA has provided IGU with true and complete copies of all environmental assessments, studies, and reports (1) of which AIDEA and the Acquired Companies have Knowledge and (2) that reference the real property any of the Acquired Companies owns, leases, or uses. Although neither AIDEA nor the Acquired Companies has conducted any environmental assessments regarding the leased real property used by the Acquired Companies, neither AIDEA nor the Acquired Companies has Knowledge of any environmental contamination on or under the portions of any leased or used real property where any of the Operations have been conducted. (e) Except as disclosed on Disclosure Schedule 3.16(e), neither the Acquired Companies nor AIDEA has Knowledge of any leak, spill, release, discharge, or disposal of any substance regulated under, or defined as or considered “hazardous” or “toxic” or “radioactive” or “contamination” or “pollution” under any Environmental, Health, and Safety Laws that has occurred on, in, or under the real property any of the Acquired Companies owns, leases, or uses, or has ever owned, leased, or used, in conducting the Operations, that was reportable or should have been reported to any government or governmental agency, or that was or could have been subject to clean up or remediation, under any Environmental, Health, and Safety Laws. (f) Except as disclosed on Disclosure Schedule 3.16(f), to the Knowledge of AIDEA and the Acquired Companies, there is no underground storage tank present on any real property any of the Acquired Companies owns, leases, or uses or has owned, leased or used, in conducting the Operations.

  • Environmental, Health and Safety Matters (a) Comply in all material respects with all applicable Environmental Laws, including, without limitation, obtaining and complying with and maintaining any and all licenses, approvals, notifications, registrations or permits required by applicable Environmental Laws. For purposes of this Section 5.12(a), material noncompliance by the Company, any of its Subsidiaries or any tenant or subtenant, with any applicable Environmental Law shall be deemed not to constitute a breach of this covenant provided that, upon learning of any actual or suspected material noncompliance, the Company and the relevant Subsidiaries shall promptly undertake all reasonable efforts to achieve material compliance (or contest in good faith by appropriate proceedings the alleged violation or applicable Environmental Law at issue and (to the extent required by GAAP) provide on the books of the Company or any of its Subsidiaries, as the case may be, reserves in accordance with GAAP with respect thereto), and provided further that, in any case, such noncompliance, and any other noncompliance with applicable Environmental Law, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. (b) Promptly comply in all material respects with all lawful orders and directives of all Governmental Authorities regarding applicable Environmental Laws, except to the extent that the validity thereof is currently being contested in good faith by appropriate proceedings and (to the extent required by GAAP) reserves in accordance with GAAP with respect thereto have been provided on the books of the Company or any of its Subsidiaries, as the case may be. (c) Defend, indemnify and hold harmless the Administrative Agent and the Lenders, and their respective parents, subsidiaries, affiliates, employees, agents, officers and directors, from and against any claims, demands, penalties, fines, liabilities, settlements, damages, costs and expenses of whatever kind or nature, known or unknown, contingent or otherwise, arising out of, or in any way relating to the violation of, noncompliance with or liability under any Environmental Laws applicable to the Company or any of its Subsidiaries or any of their respective operations or properties, or any orders, requirements or demands of Governmental Authorities related thereto, including, without limitation, attorney’s and consultant’s fees, investigation and laboratory fees, response costs, court costs and litigation expenses, except to the extent that any of the foregoing arise out of the gross negligence or willful misconduct of (or, as determined pursuant to a claim initiated by the Company, breach in bad faith of its express obligations under the applicable Loan Documents by) the party seeking indemnification therefor, in each case, as determined by a final non-appealable judgment by a court of competent jurisdiction. This indemnity shall continue in full force and effect regardless of the termination of this Agreement.

  • HEALTH, SAFETY AND ENVIRONMENT In the performance of this Contract, Contractor and Operator shall conduct Petroleum Operations with due regard to health, safety and the protection of the environment (“HSE”) and the conservation of natural resources, and shall in particular:

  • HEALTH AND SAFETY 25.01 The Employer is subject to the provisions of the Occupational Health and Safety Act of the Province of Ontario and its regulations, including the provision that calls for a worker representative selected by the Union on the University Joint Health and Safety Committees. It is agreed that the University and the Union will cooperate to the fullest possible extent in the prevention of accidents and the promotion of safety and health at University workplaces. To this end, the parties acknowledge and agree that all University Employees on University and third-party premises where Employees work, are required to comply with work- site specific policies, procedures, regulations, and standards relating to health and safety. 25.02 The Employer recognizes the right of workers to be informed about hazards in the workplace, to be provided with appropriate training, and the right to refuse unsafe work in accordance with the Occupational Health and Safety Act where there is an immediate danger to the Employee’s health and safety or to the health and safety of others. 25.03 The Union will select a worker representative for each applicable Joint Health and Safety Committee formed under the Occupational Health and Safety Act. Time spent attending meetings of the Committee or carrying out duties as a worker representative shall be considered time worked. 25.04 A worker representative on a Joint Health and Safety Committee may become a certified worker representative on the Committee. The University will provide the required training for certification at no cost to the Employee or the Union. Time spent in such training shall be considered time worked, as outlined in Article 13 – Hours of Work and Overtime. 25.05 When a worker representative on a Joint Health and Safety Committee ceases to be employed in the Bargaining Unit, he/she will cease to be a worker representative on the Committee. 25.06 The University will supply, and Employees will wear and/or utilize, personal protective equipment and the other devices that the University requires Employees to wear and/or utilize. 25.07 The Employer shall provide information, training and supervision to an Employee to protect the health and safety of that Employee. With reference to Article 13, time spent in such training shall be considered time worked, as outlined in Article 13 – Hours of Work and Overtime. 25.08 The name and contact information of the Health and Safety Officer in each Academic Unit shall be posted in the Department/Academic Unit. 25.09 In accordance with the Occupational Health and Safety Act, persons with authority in the workplace, including any Employees, shall ensure that persons under their authority are informed of health and safety hazards, and advised of policies and procedures associated with the safe handling of materials and equipment.

  • 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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