Data and Safety Monitoring Reports Sample Clauses

Data and Safety Monitoring Reports. Company will provide Stanford with any data and safety monitoring reports related to the Research Program that may: (i) affect the safety and welfare of current or former Research Program participants, or (ii) influence the conduct of the Research Program. Stanford will submit such reports to the IRB as required. During the Research Program and for at least two (2) years following the completion of the Research Program at all sites, Company will promptly provide Stanford and Principal Investigator with a written report of any routine monitoring findings in site monitoring reports and data safety monitoring committee reports including, but not limited to, data and safety analyses that may: (i) affect the safety and welfare of current or former Research Program participants, or (ii) influence the conduct of the Research Program.
AutoNDA by SimpleDocs
Data and Safety Monitoring Reports. Company will provide NEOMED with any data and safety monitoring reports related to the Research Program that may: (i) affect the safety and welfare of current or former Research Program participants, or (ii) influence the conduct of the Research Program. NEOMED will submit such reports to the IRB as required. During the Research Program and for at least two (2) years following the completion of the Research Program at all sites, Company will promptly provide NEOMED and Principal Investigator with a written report of any routine monitoring findings in site monitoring reports and data safety monitoring committee reports including, but not limited to, data and safety analyses that may: (i) affect the safety and welfare of current or former Research Program participants, or (ii) influence the conduct of the Research Program.
Data and Safety Monitoring Reports. Each party will provide the other party with any data and safety monitoring reports related to the Research Program that would reasonably be expected to affect the safety and welfare of current or former Research Program participants. During the Research Program and for at least […***…] following the completion of the Research Program at all sites, each party will provide the other party and Principal Investigator with a written report of any routine monitoring findings in site monitoring reports and data safety monitoring committee reports to the extent such findings or reports would reasonably be expected to affect the safety and welfare of current or former Research Program participants.

Related to Data and Safety Monitoring Reports

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • CERTIFICATION REGARDING DRUG-FREE WORKPLACE REQUIREMENTS 1. The Contractor certifies that it will provide a drug-free workplace by: a. Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Contractor’s workplace and specifying the actions that will be taken against employees for violation of such prohibition;

  • Quality Assurance Requirements There are no special Quality Assurance requirements under this Agreement.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower’s part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower’s part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Information Technology Enterprise Architecture Requirements If this Contract involves information technology-related products or services, the Contractor agrees that all such products or services are compatible with any of the technology standards found at xxxxx://xxx.xx.xxx/iot/2394.htm that are applicable, including the assistive technology standard. The State may terminate this Contract for default if the terms of this paragraph are breached.

  • Insurance and Fingerprint Requirements Information Insurance If applicable and your staff will be on TIPS member premises for delivery, training or installation etc. and/or with an automobile, you must carry automobile insurance as required by law. You may be asked to provide proof of insurance. Fingerprint It is possible that a vendor may be subject to Chapter 22 of the Texas Education Code. The Texas Education Code, Chapter 22, Section 22.0834. Statutory language may be found at: xxxx://xxx.xxxxxxxx.xxxxx.xxxxx.xx.xx/ If the vendor has staff that meet both of these criterion: (1) will have continuing duties related to the contracted services; and (2) has or will have direct contact with students Then you have ”covered” employees for purposes of completing the attached form. TIPS recommends all vendors consult their legal counsel for guidance in compliance with this law. If you have questions on how to comply, see below. If you have questions on compliance with this code section, contact the Texas Department of Public Safety Non-Criminal Justice Unit, Access and Dissemination Bureau, FAST-FACT at XXXX@xxxxx.xxxxx.xx.xx and you should send an email identifying you as a contractor to a Texas Independent School District or ESC Region 8 and TIPS. Texas DPS phone number is (000) 000-0000. See form in the next attribute to complete entitled: Texas Education Code Chapter 22 Contractor Certification for Contractor Employees

  • 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.

  • Minimum Site Requirements for TIPS Sales (when applicable to TIPS Sale). Cleanup: When performing work on site at a TIPS Member’s property, Vendor shall clean up and remove all debris and rubbish resulting from their work as required or directed by the TIPS Member or as agreed by the parties. Upon completion of work, the premises shall be left in good repair and an orderly, neat, clean and unobstructed condition. Preparation: Vendor shall not begin a project for which a TIPS Member has not prepared the site, unless Vendor does the preparation work at no cost, or until TIPS Member includes the cost of site preparation in the TIPS Sale Site preparation includes, but is not limited to: moving furniture, installing wiring for networks or power, and similar pre‐installation requirements. Registered Sex Offender Restrictions: For work to be performed at schools, Vendor agrees that no employee of Vendor or a subcontractor who has been adjudicated to be a registered sex offender will perform work at any time when students are, or reasonably expected to be, present unless otherwise agreed by the TIPS Member. Vendor agrees that a violation of this condition shall be considered a material breach and may result in the cancellation of the TIPS Sale at the TIPS Member’s discretion. Vendor must identify any additional costs associated with compliance of this term. If no costs are specified, compliance with this term will be provided at no additional charge. Safety Measures: Vendor shall take all reasonable precautions for the safety of employees on the worksite, and shall erect and properly maintain all necessary safeguards for protection of workers and the public. Vendor shall post warning signs against all hazards created by the operation and work in progress. Proper precautions shall be taken pursuant to state law and standard practices to protect workers, general public and existing structures from injury or damage. Smoking: Persons working under Agreement shall adhere to the TIPS Member’s or local smoking statutes, codes, ordinances, and policies.

  • Child Abuse Reporting Requirements A. Grantees shall comply with child abuse and neglect reporting requirements in Texas Family Code Chapter 261. This section is in addition to and does not supersede any other legal obligation of the Grantee to report child abuse. B. Grantee shall use the Texas Abuse Hotline Website located at xxxxx://xxx.xxxxxxxxxxxxxx.xxx/Login/Default.aspx as required by the System Agency. Grantee shall retain reporting documentation on site and make it available for inspection by the System Agency.

  • 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, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; 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 inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!