Common use of Study Monitoring Clause in Contracts

Study Monitoring. The study will be monitored by authorized representatives of the Sponsor throughout its duration by means of personal visits to the Investigator’s facilities and through other communications (e.g. telephone calls, written correspondence). Monitoring visits will be scheduled at mutually agreeable times periodically throughout the study and at frequency deemed appropriate for the study. These visits will be conducted to evaluate the progress of the study, ensure the rights and well- being of the subjects are protected, check that the reported clinical study data are accurate, complete and verifiable from source documents, and the conduct of the study is in compliance with the approved protocol and amendments, GCPs and applicable national regulatory requirements. A monitoring visit will include a review of the essential clinical study documents (regulatory documents, CRFs, source documents, drug disposition records, subject informed consent forms, etc.) as well as discussion on the conduct of the study with the Investigator and staff. The Investigator and staff should be available during these visits to facilitate the review of the clinical study records and resolve/document any discrepancies found during the visit.

Study Monitoring. The study will be monitored by authorized representatives of the Sponsor throughout its duration by means of personal visits to the Investigator’s facilities and through other communications (e.g. e.g., telephone calls, written correspondence). Monitoring visits will be scheduled at mutually agreeable times periodically throughout the study and at frequency deemed appropriate for the study. These visits will be conducted to evaluate the progress of the study, ensure the rights and well- being of the subjects are protected, check that the reported clinical study data are accurate, complete and verifiable from source documents, and the conduct of the study is in compliance with the approved protocol and amendments, GCPs and applicable national regulatory requirements. A monitoring visit will include a review of the essential clinical study documents (regulatory documents, CRFs, source documents, drug disposition records, subject informed consent forms, etc.) as well as discussion on the conduct of the study with the Investigator and staff. The Investigator and staff should be available during these visits to facilitate the review of the clinical study records and resolve/document any discrepancies found during the visit.