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. 5.2 MD Xxxxxxxx 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 Xxxxxxxx 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.
Sample 1
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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.

  • 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. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

  • Monitoring and Reporting The Programme Operator shall monitor, record and report on progress towards the programme’s outcomes in accordance with the provisions contained in the legal framework. The Programme Operator shall ensure that suitable and sufficient monitoring and reporting arrangements are made with the project promoters in order to enable the Programme Operator and the National Focal Point to meet its obligations to the Donors. When reporting on progress achieved in Annual and Final Programme Reports, the Programme Operator shall disaggregate results achieved as appropriate and in accordance with instructions received from the FMO.

  • 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.

  • 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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