Safety and Monitoring Issues Sample Clauses

Safety and Monitoring Issues. Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with the annual progress report, the Contractor must submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number. The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the Government a summary explanation and copies of documents related to all major changes in the status of ongoing protocols, including the following: 1. All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid. 2. All changes in informed consent documents, identified by version number, date, or both and dates it is valid. 3. Termination or temporary suspension of patient accrual. 4. Termination or temporary suspension of the protocol. 5. Any change in IRB approval. Visterra, Inc. HHSO100201500018C 6. Any other problems or issues that could affect the participants in the studies. Contractors must notify BARDA through the Contracting Officer’s Representative (COR) or Contracting Officer (CO) of any of the above changes by email within 72 hours for items 3 - 6 and 7 days for items 1 - 2, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC. If a clinical protocol has been reviewed by an Institutional Bio-safety Committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.
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Safety and Monitoring Issues. Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before initiation of research and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution's IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number. The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the Government a summary explanation and copies of documents related to all major changes in the status of ongoing protocols, including the following: 1. All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid. 2. All changes in informed consent documents, identified by version number, date, or both and dates it is valid. 3. Termination or temporary suspension of patient accrual.
Sample 1
Safety and Monitoring Issues. Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number. The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the Government a summary explanation and copies of documents related to all major changes in the status of ongoing protocols, including the following:
Sample 1
Safety and Monitoring Issues. 1. Institutional Review Board or Independent Ethics Committee Approval Within [***] of award and then with the annual progress report, the Contractor must submit to the COR a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide BARDA initial and annual documentation of continuing review and approval, including the current approved informed consent document and federal wide number. The Contractor must ensure that the application as well as all protocols is reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the COR copies of documents related to all major changes in the status of ongoing protocols, including the following:  All amendments or changes to the protocol, identified by protocol version number, date, or both and dates it is valid.  All changes in informed consent documents, identified by version number, dates, or both and dates it is valid.  Termination or temporary suspension of patient accrual.  Termination or temporary suspension of the protocol.  Any change in IRB approval.  Any other problems or issues that could affect the participants in the studies. The Contractor must notify the COR and CO of any of the above changes within [***] by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC. If a clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.
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Safety and Monitoring Issues 
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Related to Safety and Monitoring Issues

  • WORKPLACE SAFETY AND INSURANCE 41.1 Where an employee is absent by reason of an injury or an occupational disease for which a claim is made under the Workplace Safety and Insurance Act, his or her salary shall continue to be paid for a period not exceeding thirty (30) days. If an award is not made, any payments made under the foregoing provisions in excess of that to which he or she is entitled under Articles 44.1 and 44.6 (Short Term Sickness Plan) shall be an amount owing by the employee to the Employer. 41.2 Where an employee is absent by reason of an injury or an occupational disease for which an award is made under the Workplace Safety and Insurance Act, his or her salary shall continue to be paid for a period not exceeding three (3) consecutive months or a total of sixty-five (65) working days where such absences are intermittent, following the date of the first absence because of the injury or occupational disease, and any absence in respect of the injury or occupational disease shall not be charged against his or her credits. 41.3 Where an award is made under the Workplace Safety and Insurance Act to an employee that is less than the regular salary of the employee and the award applies for longer than the period set out in Article 41.2 and the employee has accumulated credits, his or her regular salary may be paid and the difference between the regular salary paid after the period set out in Article 41.2 and the compensation awarded shall be converted to its equivalent time and deducted from his or her accumulated credits. 41.4 Where an employee receives an award under the Workplace Safety and Insurance Act, and the award applies for longer than the period set out in Article 41.2 (i.e. three (3) months), the Employer will continue subsidies for Basic Life, Long Term Income Protection, Supplementary Health and Hospital and the Dental Plans for the period during which the employee is receiving the award. The Employer shall continue to make the Employer’s pension contributions unless the employee gives the Employer a written notice that the employee does not intend to pay the employee’s pension contributions. 41.5 Where an employee is absent by reason of an injury or an occupational disease for which an award is made under the Workplace Safety and Insurance Act, the employee shall not be entitled to a leave of absence with pay under Article 44 (Short Term Sickness Plan) as an option following the expiry of the application of Article 41.2.

  • Prescription Safety Glasses Prescription safety glasses will be furnished by the employer. The employer retains the authority to establish reasonable rules and procedures regarding frequency of issue, replacement of damaged glasses, limits on reimbursement costs and coordination with the employer's vision plan.

  • Public safety compliance The Hirer shall comply with all conditions and regulations made in respect of the premises by the Fire Authority, Local Authority, the Licensing Authority or otherwise, particularly in connection with any event which constitutes regulated entertainment, at which alcohol is sold or provided or which is attended by children. (a) The Hirer acknowledges that they have received information in the following matters: (b) In advance of an entertainment or play the Hirer shall check the following items:

  • 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. 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.

  • COMPLIANCE WITH HEALTH, SAFETY, AND ENVIRONMENTAL REGULATIONS The Contractor, it’s Subcontractors, and their respective employees, shall comply fully with all applicable federal, state, and local health, safety, and environmental laws, ordinances, rules and regulations in the performance of the services, including but not limited to those promulgated by the City and by the Occupational Safety and Health Administration (OSHA). In case of conflict, the most stringent safety requirement shall govern. The Contractor shall indemnify and hold the City harmless from and against all claims, demands, suits, actions, judgments, fines, penalties and liability of every kind arising from the breach of the Contractor’s obligations under this paragraph.

  • Safety and Security Procedures Contractor shall maintain and enforce, at the Contractor Work Locations, industry-standard safety and physical security policies and procedures. While at each Court Work Location, Contractor shall comply with the safety and security policies and procedures in effect at such Court Work Location.

  • 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:

  • OCCUPATIONAL SAFETY AND HEALTH A. Consultant will perform the Services in compliance with the most current versions of all laws, standards, rules, and regulations of the Occupational Safety and Health Act, and all state and federal laws and regulations relating to safety and health standards. Consultant shall perform the Services in compliance with, will furnish only supplies, articles, and equipment that comply with such laws, standards, and regulations. B. Consultant shall immediately notify Valley Water in the event of any personal injury accident or occurrence occurring during the performance of the Services. Upon Valley Water’s request, Consultant shall provide Valley Water with documentation fully describing the accident and injury and the actions implemented to prevent similar occurrences.

  • Safety and Protection Where applicable, the PERFORMING PARTY shall be responsible for requiring employees, contractors, and subcontractors to maintain and supervise all necessary safety precautions and programs in connection with the Grant Activities. The PERFORMING PARTY shall take all necessary precautions to protect the health and safety of the public during performance of the Grant Activities.

  • Fraud, Waste, and Abuse Contractor understands that HHS does not tolerate any type of fraud, waste, or abuse. Violations of law, agency policies, or standards of ethical conduct will be investigated, and appropriate actions will be taken. Pursuant to Texas Government Code, Section 321.022, if the administrative head of a department or entity that is subject to audit by the state auditor has reasonable cause to believe that money received from the state by the department or entity or by a client or contractor of the department or entity may have been lost, misappropriated, or misused, or that other fraudulent or unlawful conduct has occurred in relation to the operation of the department or entity, the administrative head shall report the reason and basis for the belief to the Texas State Auditor’s Office (SAO). All employees or contractors who have reasonable cause to believe that fraud, waste, or abuse has occurred (including misconduct by any HHS employee, Grantee officer, agent, employee, or subcontractor that would constitute fraud, waste, or abuse) are required to immediately report the questioned activity to the Health and Human Services Commission's Office of Inspector General. Contractor agrees to comply with all applicable laws, rules, regulations, and System Agency policies regarding fraud, waste, and abuse including, but not limited to, HHS Circular C-027. A report to the SAO must be made through one of the following avenues: ● SAO Toll Free Hotline: 1-800-TX-AUDIT ● SAO website: xxxx://xxx.xxxxx.xxxxx.xx.xx/ All reports made to the OIG must be made through one of the following avenues: ● OIG Toll Free Hotline 0-000-000-0000 ● OIG Website: XxxxxxXxxxxXxxxx.xxx ● Internal Affairs Email: XxxxxxxxXxxxxxxXxxxxxxx@xxxx.xxxxx.xx.xx ● OIG Hotline Email: XXXXxxxxXxxxxxx@xxxx.xxxxx.xx.xx. ● OIG Mailing Address: Office of Inspector General Attn: Fraud Hotline MC 1300 P.O. Box 85200 Austin, Texas 78708-5200

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