Data and Safety Monitoring Plan Sample Clauses

Data and Safety Monitoring Plan. INSTITUTION and COMPANY acknowledge that for NIH Awards applicants must include a Data and Safety Monitoring (DSM) Plan that is commensurate with the risk level of the proposed clinical trial (see xxxx://xxxxxx.xxx.xxx/grants/guide/notice- files/not98-084.html). For exploratory clinical trials it generally will be acceptable for the data and safety monitoring to be conducted by an investigator appointed Study Monitoring Committee (SMC), an Independent Medical Monitor (IMM), or, for single site trials involving low risk, the Program Director/Principal Investigator and his/her IRB. However, NIH may decide to establish an independent Data and Safety Monitoring Board (DSMB) depending on the scope and risk of the trial. Applicants should refer to NIH’s policy on data and safety monitoring (xxxx://xxxxxx.xxx.xxx/grants/guide/notice-files/NOT-OD-00-038.html) as well as the NINDS Guidelines for Data and Safety Monitoring (xxxx://xxx.xxxxx.xxx.xxx/research/clinical_research/policies/data_safety_monitoring.htm). RESEARCHER will be responsible for timely communication of DSM/SMC/IMM/DSMB findings to NIH, and will relay all DSM/SMC/IMM/DSMB written notifications to COMPANY within 45 days.
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Data and Safety Monitoring Plan. For information, visit Data and Safety Monitoring Plan.
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Data and Safety Monitoring Plan. This study has been deemed minimal risk. Because this study poses minimal risk to the subject, adverse events will only be collected or recorded if a causal relationship to the study event must be reported to the IRB-HSR within 7 days from the time the study team receives knowledge of the event.
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Data and Safety Monitoring Plan. Include an appropriate Data and Safety Monitoring Plan (DSMP) based on the investigator’s risk assessment stated below. (Note: the HIC will make the final determination of the risk to subjects.) For more information, see the Instructions, page 24. a. What is the investigator’s assessment of the overall risk level for subjects participating in this study? Minimal b. If children are involved, what is the investigator’s assessment of the overall risk level for the children participating in this study? N/A c. Copy, paste, and then tailor an appropriate Data and Safety Monitoring Plan from xxxx://xxx.xxxx.xxx/hrpp/forms-templates/biomedical.html for i. Minimal risk ii. Greater than minimal/moderate risk
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Data and Safety Monitoring Plan. Please include a Data and Safety Monitoring Plan (DSMP) that includes an explicit statement of overall risks, addresses attribution and grading of adverse events and describes procedures for monitoring the ongoing progress of the research and reporting adverse events. For more information, please see the HIC website: http://info.med.yale.edu/xxx/xxxxxxxxx/XXXX.xxx.
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Data and Safety Monitoring Plan. INSTRUCTIONS: If you have any questions completing this section call 000-0000 for assistance. A Sponsor is defined as entity that will receive data prior to publication.
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Data and Safety Monitoring Plan. This study does not have a Data Safety Monitoring Board. Results may be reviewed by the Informed Cohort Oversight Board (ICOB), a group of ethicists, scientists, physicians, genetic counselors and other health professionals with expertise in genetics and ethics. The ICOB is completely separate from the investigators of this research project. The ICOB may help decide if it is appropriate to release a result. When making this decision, the ICOB will look at the accuracy and health importance of the research finding in addition to other factors. The purpose of the ICOB is to protect subjects from psychological stress by determining what research results are appropriate to give back to subjects and how to do so. Thus the ICOB functions similar to a Data Safety Monitoring Board.
Sample 1
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Related to Data and Safety Monitoring Plan

  • 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.

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

  • 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.

  • Human and Financial Resources to Implement Safeguards Requirements The Borrower shall make available necessary budgetary and human resources to fully implement the EMP and the RP.

  • 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.

  • CONTRACT WORK HOURS AND SAFETY STANDARDS As per the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701-3708), where applicable, all Customer Purchase Orders in excess of ,000 that involve the employment of mechanics or laborers must include a provision for compliance with 40 U.S.C. 3702 and 3704, as supplemented by Department of Labor regulations (29 CFR Part 5). Under 40 U.S.C. 3702 of the Act, each contractor must be required to compute the wages of every mechanic and laborer on the basis of a standard work week of 40 hours. Work in excess of the standard work week is permissible provided that the worker is compensated at a rate of not less than one and a half times the basic rate of pay for all hours worked in excess of 40 hours in the work week. The requirements of 40 U.S.C. 3704 are applicable to construction work and provide that no laborer or mechanic must be required to work in surroundings or under working conditions which are unsanitary, hazardous or dangerous. These requirements do not apply to the purchases of supplies or materials or articles ordinarily available on the open market, or contracts for transportation or transmission of intelligence.

  • 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.

  • 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.

  • Project Implementation Manual The Recipient, through the PCU, shall: (i) take all action required to carry out Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4 (ii) of the Project in accordance with the provisions and requirements set forth or referred to in the Project Implementation Manual; (ii) submit recommendations to the Association for its consideration for changes and updates of the Project Implementation Manual as they may become necessary or advisable during Project implementation in order to achieve the objective of Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4(ii) of the Project; and (iii) not assign, amend, abrogate or waive the Project Implementation Manual or any of its provisions without the Association’s prior agreement. Notwithstanding the foregoing, if any of the provisions of the Project Implementation Manual is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall prevail and govern.

  • Contract Work Hours and Safety Standards Act The following clauses apply to any Federal-aid construction contract in an amount in excess of $100,000 and subject to the overtime provisions of the Contract Work Hours and Safety Standards Act. These clauses shall be inserted in addition to the clauses required by 29 CFR 5.5(a) or 29 CFR 4.6. As used in this paragraph, the terms laborers and mechanics include watchmen and guards.

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