Monitoring and FDA Audits Clause Samples

Monitoring and FDA Audits. 5.1 Tokalas and CRO will each have the right, with reasonable advance notice to MD ▇▇▇▇▇▇▇▇, 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 ▇▇▇▇▇▇▇▇ 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. 5.2 MD ▇▇▇▇▇▇▇▇ shall notify Tokalas, promptly and at least within twenty-four (24) hours after such, of any regulatory inquiries, inspections, site visits (whether announced or unannounced), correspondence or communication that relates to the clinical trial, and shall consult and cooperate with Tokalas in responding to any such event. Tokalas may attend any such inspections or site visits if permitted by Laws and if feasible. To the extent permitted by Laws, MD ▇▇▇▇▇▇▇▇ and the Investigators shall provide Tokalas with a draft of any response any one of them generates to any inspection or any other communications from any regulatory agency relating to the clinical trial and will reasonably consider Tokalas’s comments on such response.
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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”. b. The AGENCY agrees to permit persons duly authorized by the COUNTY to interview any clients and all current and/or former employees of the AGENCY to be assured of the AGENCY’S satisfactory performance of the terms of this Contract. c. Following such evaluation, monitoring, and/or audit, the COUNTY will deliver a report of its findings and recommendations with regard to the AGENCY’S conformance with this Contract’s terms and conditions to the AGENCY and/or Board of Directors’ President, and members, whenever applicable. If deficiencies are noted, a written notice of corrective action will be issued to the AGENCY which will specify deficiencies and provide a timeline for correction of those deficiencies. Within the designated timeframe in the written notice of corrective action, the AGENCY shall submit to the COUNTY’S CCC manager (“Manager”), or their designee, a corrective action plan to rectify all deficiencies identified by the COUNTY. d. Failure by the AGENCY to correct noted deficiencies, as outlined in the written notice of corrective action, may result in the AGENCY being deemed in breach of the Contract terms. e. The AGENCY shall cooperate with the COUNTY on all reviews to ensure compliance with all applicable COUNTY guidelines and requirements for general fund recipients.

  • Program Monitoring and Evaluation 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 The Provider agrees to allow access to the Department for purposes of monitoring and review. This access includes but is not limited to client records, fiscal records, staffing records, policy and procedural manuals, facilities, staff, and children in care of the Department. The Department will conduct quality reviews, which may include site-based quality review visits.

  • 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.