Quality Assurance and Control. 10.4.1. ACRO employ strict quality control procedures and staff undertaking this work are all appropriately trained.
Quality Assurance and Control. The Site Parties shall permit the Study Monitor, Auditor and any official with a legal right to inspect and access all relevant documentation and source data for monitoring of the progress of the Clinical Study, the proper collection and recording of Clinical Study data, the welfare of the Clinical Study Subjects, and altogether the good quality of the Clinical Study and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and Auditor’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor. The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or Auditor. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data of Clinical Study Subjects and other patients which the Study Monitor or Auditor comes across with during their monitoring or auditing activities. Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties with the name of the appointed Study Monitor or auditor, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely sign a confidentiality statement regarding the above by means of a specific letter. of the template for such letter is annexed to this Agreement below, as Annex 4. The Site Parties shall promptly inform the Sponsor in writing of any intended or actual inspection, written enquiry and/or visit to the Site Parties by any regulatory authority in connection with the Clinical Study and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Study. The Site Parties shall allow Sponsor’s representatives to be present during any such visit. The Site Parties shall take appropriate measures and/or corrective actions without delay as the Sponsor may reasonably require in order to solve all problems found and reported by the Study Monitors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to and verify information relating to the Clinical Study, as required by and ...
Quality Assurance and Control. 1. Contractor shall:
Quality Assurance and Control. In an effort to ensure that the Consultant provides high quality work, the Client will assign the CEO of the Client company to review and approve the work of the Consultant. In the event that the Consultant uses a third party, the Consultant is responsible for the quality of the work delivered by the third party.
Quality Assurance and Control. 4.1 Supplier shall have an implemented and documented quality assurance system in accordance with ISO 9000 or equivalent.
Quality Assurance and Control. 6.1. The Site Parties shall ensure that all procedures defined in the Protocol are complied with, so that all data generated at the Trial Site are reliable and have been processed correctly (especially the randomization lists, and the blind character of the Clinical Trial as the case may be) and will ensure that the content of the CRFs or e-CRFs will accurately reflect source documents.
Quality Assurance and Control. 6.1. The Site Parties shall permit the Trial Monitor and any Auditor access to all relevant clinical data of Clinical Trial Subjects for monitoring of the progress of the Clinical Trial, the proper collection and recording of Clinical Trial data, the welfare of the Clinical Trial Subjects, and altogether the good quality of the Clinical Trial and compliance with applicable Law and Sponsor’s Standard Operating Procedures. The Trial Monitor’s access will be arranged at mutually convenient times and on reasonable notice.
Quality Assurance and Control. Licensee will perform quality assurance inspections to assure the compliance of the Licensed Products with the product specifications set forth in any purchase order and to meet all applicable health and safety requirements. Licensee will maintain separate lot code control for every batch produced and maintain a file recording where all products by lot code where shipped. Licensee shall retain samples of each batch of Licensed Products produced and filled for a period of no less than two (2) years. Licensee shall ensure that any Manufacturers and any and all raw material suppliers maintain a quality control program consistent with Applicable Law.
Quality Assurance and Control. 27.1 The Provider shall adhere to the standards of service detailed in the Service Specification.
Quality Assurance and Control. To the extent applicable, the Site Parties shall permit the Study Monitor, Auditor, IRB and any official with a legal right to inspect and access all relevant documentation and source data for monitoring of the progress of the Clinical Study, the proper collection and recording of Clinical Study data, and altogether the good quality of the Clinical Study and compliance with applicable Law. Parties will make in good faith arrangements concerning the planning and follow-up of such audits or inspections.
