Quality assurance. A. Examine existing and finish grades as shown on grading plan and excavation and fill as indicated on plans and elevations. Protect and maintain site boundaries and project limits during construction. If disturbed, destroyed or exceeded, repair as directed by Engineer.
Quality assurance. The supplier is responsible for an analysis of the root cause of the reject. If AAE returns a product as a reject, then AAE expects the supplier to perform an analysis after receipt of the defective product. This analysis can be an internal action plan, Corrective Actions Preventive Actions(CAPA), or 8D.
Quality assurance. The study teams at each participating site are responsible for the management of the study. The principal investigator and the sub-investigators of the ULB-Hôpital ERASME will communicate with the local centers on a regular basis. We will use standardized forms and questionnaires, which have to be filled out by the study teams and/or patients, in order to collect the right data at the right time. We also developed Study Operating Procedures (SOPs) about how to extract Comma Separated Value (CSV) files from CareLinkTM, LibreView, Clarity and Yourloops , for the storage of CGM-data. The investigators and the institutions will permit trial-related monitoring, audits, EC review and regulatory inspections (where appropriate) by proving direct access to source data and other documents. This study will be conducted in compliance with the principles of the Declaration of Helsinki (2013), the principles of Good Clinical Practice (GCP) and in accordance with all applicable regulatory requirements. This protocol and related documents will be submitted for review to the Ethics Committees of all the participating sites. The Study can and will be conducted only on the basis of prior informed consent by the Subjects, or their legal representatives, to participate in the Study. The Participating Site shall obtain a signed informed consent form (ICF) for all patients prior to their enrollment and participation in the Study in compliance with all applicable laws, regulations and the approval of the (local) Ethics Committee, if required. The Participating Site shall retain such ICFs in accordance with the requirements of all applicable regulatory agencies and laws. The Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site and/or Investigator in this Study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study. The collection, processing and disclosure of personal data, such as patient health and medical information is subject to compliance with applicable personal data protection and the processing of personal data (Regulation (EU) 2016/679 also referred as the General Data Protection Regulation (“GDPR”) and the Belgian Law of July 30, 2018, on the protection of natural persons with regard to the processing of personal data). The collected data will be coded. The research team is obligated to protec...