Safety and Medical Sample Clauses

Safety and Medical. Medical Monitoring (during business hours) The medical aspects of The Sponsor’s clinical program will be overseen by one of Omnicare CR’s staff physicians who will be assigned to the study during business hours as the Project’s Medical Monitor. In addition to acting as medical advisor to the Project Team, the Medical Monitor is responsible for the following: • Addressing medical inquiries, internal or external • Reviewing of clinical documentation (protocol, draft CRF, sample informed consent form) • Project-specific medical training • Evaluating patient eligibility (in conjunction with the Medical Director of the Sponsor) • Participating in team meetings • Review of Safety Data, such as laboratory results, ECGs, SAEs, AE Listings • Reviewing study reports, regulatory submissions and study manuscripts Safety Coordinator The Coordinating Safety Officer assigned to the Project will coordinate all activities relating to safety. These activities include attendance of internal and external team meetings, safety training of Project staff or sites, communication of safety information to Omnicare CR Project Management and Data Management departments as well as the sponsor, and tracking the flow of safety information for the life of the Project. The Coordinating Safety officer will also be responsible for the generation of, and any required revisions to, the Study Safety Plan, a comprehensive document, which defines the process and flow for contracted safety services. Safety coordination also includes assistance with the SAE reconciliation process, and completion of sponsor derived queries of the sites. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. SAE Reporting- (with initial descriptive summaries) Omnicare CR can provide initial descriptive summaries for all identified serious adverse events. The descriptive summaries will be written from information provided by the investigator on the SAE report forwarded to Omnicare CR at the time of the event. If significant follow-up information becomes available, the narrative will be updated accordingly. SAE Reporting (Follow-up/Revision Reports>2) Updates or revisions to an initial SAE report greater than two (2) will be billed per unit based upon the actual number of additional reports required. The Coordinating Safety Officer trac...
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Safety and Medical. Medical and emergencies You must: assist your Overseas student to attend any routine medical, dental, hospital or other health- related appointments; and notify us if your Overseas student suffers Harm, an illness or injury. If an emergency or critical incident occurs, you must: obtain any necessary emergency medical assistance for your Overseas student; and notify us immediately (after school hours, report any incident involving the Overseas student to 1800QSTUDY (1800778839) as required in the DEi incident management procedure).
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Safety and Medical. Medical Monitoring (during business hours) The medical aspects of The Sponsor’s clinical program will be overseen by one of Omnicare CR’s staff physicians who will be assigned to the study during business hours as the Project’s Medical Monitor. In addition to acting as medical advisor to the Project Team, the Medical Monitor is responsible for the following: • Addressing medical inquiries, internal or external • Reviewing of clinical documentation (protocol, draft CRF, samle informed consent form) • Project-specific medical training • Evaluating patient eligibility (in conjunction with the Medical Director of the Sponsor) • Participating in team meetings • Review of Safety Data, such as laboratory results, ECGs, SAEs, AE Listings • Reviewing study reports, regulatory submissions and study manuscripts Safety Coordinator The Coordinating Safety Officer assigned to the Project will coordinate all activities relating to safety. These activities include attendance of internal and external team meetings, safety training of Project staff or sites, communication of safety information to Omnicare CR Project Management and Data Management departments as well as the sponsor, and tracking the flow of safety information for the life of the Project. The Coordinating Safety officer will also be responsible for the generation of, and any required revisions to, the Study Safety Plan, a comprehensive documents, which defines the process and flow for contracted safety services. Safety coordination also includes assistance with the SAE reconciliation process, and completion of sponsor derived queries of the sites.
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Safety and Medical. Medical Monitoring availability during business hours (flat fee of **** hours per month from first patient in through last patient out) > Americas Months **** **** **** **** **** Greater than **** hours per month will be billed at hourly rate (from first patient in through last patient out); Billed on actuals > Americas Hours **** **** **** **** **** • Medical Monitoring during Study Start Up and Study Close-out (Billed on actuals) > Americas Hours **** **** **** **** **** • Safety Coordinator > Americas — assumes **** day per month for **** months Days **** **** **** **** **** • SAE Reporting (with initial descriptive summary) Billed on actuals Report **** **** **** **** **** • SAE Reporting (Follow- up/Revision Reports >****) Billed on actuals Report **** **** **** **** **** > Data Entry into **** (actuals will be billed) SAE **** **** **** **** **** • Medical Review of Protocol (xxxx on actuals) Days **** **** **** **** **** Sub-Total Safety and Medical **** **** ****
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Safety and Medical. Medical Monitoring availability during business hours (flat fee of **** hours per month from first patient in through last patient out) Months **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Services Unit # Units Unit Cost (A$) Fees (A$) Estimated Pass-Thru (A$) Estimated Total Cost (A$) > Greater than **** hours per month will be billed at hourly rate (from first patient in through last patient out) (actuals will be billed) Hours **** **** **** **** **** • Medical Monitoring during Study Start Up and Study Close-out (actuals will be billed) Hours **** **** **** **** **** • Safety Coordinator - assumes **** day per month for **** months plus **** additional day for Safety Plan development Days **** **** **** **** **** • Safety Review of CRFs and Queries Case **** **** **** **** **** • SAE Reporting To Sponsor (with initial descriptive summary); actuals will be billed Report **** **** **** **** **** • **** > Project Set-Up (costs included in KO1504) Project **** **** **** **** **** > Monthly Database Maintenance (first patient in to database close; included in KO1504) Month **** **** **** **** **** > Data Entry into **** (actuals will be billed) SAE **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Services Unit # Units Unit Cost (A$) Fees (A$) Estimated Pass-Thru (A$) Estimated Total Cost (A$) • Safety Reporting of SAEs to Investigator Sites —Int’l (estimated **** mins per reportable SAE (‘SUSAR’) per site; actuals will be billed) SUSAR **** **** **** **** **** • Safety Reporting to Regulatory Authorities — Int’l (assumes generation of CIOMS forms; estimated **** hours per reportable SAE (‘SUSAR’); actuals will be billed) SUSAR **** **** **** **** **** Sub Total Safety and Medical **** **** ****
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Safety and Medical. Manages workers’ compensation, return-to-work, Department of 7 Transportation and other health and safety programs. 8 Training and Development: Ensures an effective professional workforce through the 9 development and delivery of training programs, leadership development, work force 10 planning, surveys and performance management systems.
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Safety and Medical. Oversee worker’s compensation and return-to-work programs, DOT, and other health and safety programs. Winning Culture – Work to ensure a workforce that is engaged, innovative, accountable, and high-performing. Training and Development – Ensure an effective professional workforce through the development/delivery of programs through the GPE University; identify suitable external programs and leadership development opportunities; and identify, coaching, and development of high potential employees; and oversee an assessment center, workforce planning, periodic employee surveys, and effective performance management processes. Human Resource Information System – Ensure secure and effective systems that allow accurate reporting of employee-related information; develop and implement systems and processes that enable increased employee and manager self-service; and promote and implement process improvements for HR. HR Service Center - The HR Service Center provides a “one-stop shop” for efficient response to employees’ and retirees’ HR questions.
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Related to Safety and Medical

  • SAFETY AND HEALTH 20.1 The Employer, employee and Union have a significant responsibility for workplace safety and health.

  • Health and Safety 16.01 The Employer, Union and the employees shall comply with the provisions of the Occupational Health and Safety Act where and when applicable. The Employer shall provide working conditions at all times which are not prejudicial to the health or efficiency of the workers. Employees are required to report to their Employer any unsafe work conditions, or violation of any safe work policies or procedures established by the Employer, or any violation of relevant safe work legislation.

  • HEALTH AND WELFARE 36.01 Health and welfare benefits shall be as contained in Appendix "A" of this Agreement and shall form part of this Agreement.

  • Safety Where an employee is prevented from working at the employee’s particular function as a result of unsafe conditions caused by the inclement weather, the employee may be transferred to other work in the employee’s classification on site, until the unsafe conditions are rectified. Where such alternative is not available and until the unsafe conditions are rectified, the employee shall remain on site. The employee shall be paid for such time without reduction of the employees’ inclement weather entitlement.

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