Monitoring and FDA Audits Sample Clauses

Monitoring and FDA Audits. 5.1 Tokalas and CRO will each have the right, with reasonable advance notice to MD Xxxxxxxx, to monitor and/or audit the conduct of the clinical trial and conduct such other activities as necessary to comply with Laws by, among other activities: (a) inspection and copying, during regular administrative business hours, of any and all Records, source documents, and correspondence (including that with the IRB and FDA); (b) inspection and inventory of the TK 216-01 clinical trial drug; (c) examination of the facilities in which MD Xxxxxxxx is conducting the TK 216-01 clinical trial; and (d) discussions with the Investigators and the Study Team. Tokalas or its designee shall also have the right to review each clinical trial subject’s medical records for the purpose of auditing entries made on the related CRFs. All activities under this Section 5.1 shall occur with reasonable advance notice to Investigator and during normal administrative business hours.
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Related to Monitoring and FDA Audits

  • Monitoring and Evaluation a. The AGENCY shall expeditiously provide to the COUNTY upon request, all data needed for the purpose of monitoring, evaluating and/or auditing the program(s). This data shall include, but not be limited to, clients served, services provided, outcomes achieved, information on materials and services delivered, and any other data required, in the sole discretion of the COUNTY, that may be required to adequately monitor and evaluate the services provided under this Contract. Monitoring shall be performed in accordance with COUNTY’S established Noncompliance Standards, a copy of which is attached hereto and incorporated by reference as Attachment “C”.

  • Program Monitoring and Evaluation (c) The Recipient shall prepare, or cause to be prepared, and furnish to the Association not later than six months after the Closing Date, a report of such scope and in such detail as the Association shall reasonably request, on the execution of the Program, the performance by the Recipient and the Association of their respective obligations under the Legal Agreements and the accomplishment of the purposes of the Financing.”

  • Monitoring and Review 5.1 The Council and the BID Company shall set up the Standard Services Review Panel within 28 days from the date of this Agreement the purpose of which shall be to:

  • Monitoring and Compliance Every year during the term of this Agreement on the anniversary date of the effective date of the Agreement, the Restaurant shall provide to the United States a narrative report of the actions taken during the reporting period to remove any barriers to access and otherwise enhance accessibility for individuals with disabilities at the Restaurant and any plans for action concerning ADA compliance in the coming year. The report shall include as an exhibit copies of any complaint, whether formal or informal, received during the reporting period alleging that the Restaurant was not being operated in compliance with the ADA or otherwise discriminated against any person on account of disability. The Owner and Operator of the Restaurant shall cooperate in good faith with any and all reasonable requests by the United States for access to the Restaurant and for information and documents concerning the Restaurant's compliance with this Agreement and the ADA. The United States shall have the right to verify compliance with this Agreement and the ADA, both as set forth in this Agreement and through any means available to the general public, including visits to the public areas of the Restaurant and communications with Restaurant staff. The United States shall have the right to inspect the facility at any time, and counsel for the United States need not identify themselves in the course of visits to the public areas.

  • 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.

  • Monitoring and Audit Seller shall provide information on available audit logs and reports relating to cyber and physical and security. Company may audit Seller's records to ensure Seller's compliance with the terms of this Section 1(b)(iii)G (Critical Infrastructure Protection) of this Attachment B (Facility Owned by Seller), provided that Company has provided reasonable notice to Seller and any such records of Seller's will be treated by Company as confidential.

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards.

  • Monitoring and Reporting 3.1 The Contractor shall provide workforce monitoring data as detailed in paragraph 3.2 of this Schedule 8. A template for data collected in paragraphs 3.2, 3.3 and 3.4 will be provided by the Authority. Completed templates for the Contractor and each Sub-contractor will be submitted by the Contractor with the Diversity and Equality Delivery Plan within six (6) Months of the Commencement Date and annually thereafter. Contractors are required to provide workforce monitoring data for the workforce involved in delivery of the Contract. Data relating to the wider Contractor workforce and wider Sub-contractors workforce would however be well received by the Authority. Contractors and any Sub-contractors are required to submit percentage figures only in response to paragraphs 3.2(a), 3.2(b) and 3.2(c).

  • Reporting and Monitoring Please provide a brief description of the mechanisms proposed for this project for reporting to the UNDP and partners, including a reporting schedule.

  • Monitoring Compliance Upon the request of the Lender, but without incurring any liability beyond the Guaranteed Obligations, from time to time, Guarantor shall promptly provide to the Lender such documents, certificates and other information as may be deemed reasonably necessary to enable the Lender to perform its functions under the Servicing Agreement as the same relates to the Guarantor.

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