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:
Sample 1Sample 2Sample 3See All (4)
AutoNDA by SimpleDocs
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. FORCE MAJEURE 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).
Sample 1
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. Adverse Event Reporting 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. Informed Consents 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. Patient Privacy 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.
Sample 1
Data and Safety Monitoring. Subawardee agrees to comply with NIH requirements for data and safety monitoring outlined in the NIH Grants Policy Statement.
Sample 1

Related to Data and Safety Monitoring

  • 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 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 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.

  • 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.

  • 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 and Safety Matters Except as disclosed in Schedule 4.13:

  • Customer Relations A. Actively promote DCP Holding Company in all Marketing, Sales, Public Relations, and Community activity.

  • O.S.H.A. and Environmental Compliance (a) Each Borrower has duly complied with, and its facilities, business, assets, property, leaseholds, Real Property and Equipment are in compliance in all material respects with, the provisions of the Federal Occupational Safety and Health Act, the Environmental Protection Act, RCRA and all other Environmental Laws; there have been no outstanding citations, notices or orders of non-compliance issued to any Borrower or relating to its business, assets, property, leaseholds or Equipment under any such laws, rules or regulations.

Time is Money Join Law Insider Premium to draft better contracts faster.