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.
Sample 1
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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.
Sample 1
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 intervention is suspected. If any adverse event is considered serious and unexpected, the event must be reported to the IRB-HSR within 7 days from the time the study team receives knowledge of the event.
Sample 1
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
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.
Sample 1
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.
Sample 1

Related to Data and Safety Monitoring Plan

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • 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.

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

  • Health and Safety C8.1 The Contractor shall promptly notify the Authority of any health and safety hazards which may arise in connection with the performance of the Contract. The Authority shall promptly notify the Contractor of any health and safety hazards which may exist or arise at the Authority’s Premises and which may affect the Contractor in the performance of the Contract.

  • Environment, Health, and Safety 24.4.1. The Supplier and its staff (and/or any sub-supplier and/or subcontractor) shall comply with the laws and regulations in force related to protection of the environment, the health and safety instructions applicable to the Goods and Services performed pursuant to the Contract and especially, if appropriate, to the Goodsand Services performedon any Site by a third company.

  • Environmental, Health and Safety Laws There does not exist any violation by the Borrower or any Subsidiary of any applicable federal, state or local law, rule or regulation or order of any government, governmental department, board, agency or other instrumentality relating to environmental, pollution, health or safety matters which will or threatens to impose a material liability on the Borrower or a Subsidiary or which would require a material expenditure by the Borrower or such Subsidiary to cure. Neither the Borrower nor any Subsidiary has received any notice to the effect that any part of its operations or properties is not in material compliance with any such law, rule, regulation or order or notice that it or its property is the subject of any governmental investigation evaluating whether any remedial action is needed to respond to any release of any toxic or hazardous waste or substance into the environment, the consequences of which non-compliance or remedial action could constitute an Adverse Event.

  • Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.

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