Common use of Conduct of the Research Clause in Contracts

Conduct of the Research. The parties agree to conduct the Research based upon the terms and conditions contained in this Agreement and in accordance with the Protocol attached as Appendix A. Site Evaluation. the UNIVERSITY will conduct an evaluation of the planned facilities to be used by the Institution for the Research before the performance of the Research and before implementation of the Research. Principal Investigators. DR. __________________________, MD Department of _____, [Name of Hospital] DR. __________________________, MD Department of _____, [Name of Hospital] Responsibilities of the UNIVERSITY. To provide the Institution with the necessary background information needed for the appropriate and safe conduct of the Research; To ensure that the Investigator/s are familiar with the details of the Protocol and other liabilities and responsibilities defined in this agreement, and that Investigators are committed to act accordingly; To ensure necessary training and orientation of the personnel of the Institution involved in the Research in order to conduct the Research in accordance with the Protocol; To provide the Institution with the data and documents needed for conducting the Research and guaranteeing the safety of the participants. The data and documents provided by the UNIVERSITY may be used solely for the conduct of this Research in accordance with this agreement. To ensure that qualified and instructed personnel and adequate equipment are available for the Research and that the Research may also in other respects be conducted in safe conditions; To allow participation of the involved research personnel conducting the Research in meetings and other education arranged by the UNIVERSITY; To allow monitoring and auditing at the Research site to be conducted by the UNIVERSITY, as well as domestic and foreign regulatory authorities, and, if necessary, to assist in the executing thereof. To provide the logbook of patients to the research assistant for participant selection; To provide pass or identification card for research assistant. To be fully acquainted with the Protocol and all information and documents provided by the UNIVERSITY concerning the conduct of the clinical Research; To ensure that qualified and instructed personnel, as well as adequate equipment are available for the Research, and that the Research can also in all other respects be conducted under safe conditions; To conduct the Research in accordance with the Protocol as approved by the UP Manila Ethics Committee including potential approved amendments thereto; To immediately notify the UNIVERSITY of all necessary amendments to the Protocol or any deviations from the Protocol, which are imperative to avoid immediate danger to the participants, and immediately execute necessary precautions for the protection of the participants; To ensure that all participants have given the proper written informed consent to their participation in the Research and have received sufficient information of the Research and benefits, risks, and disadvantages related thereto for giving the consent; To ensure that all the persons assisting in the Research and, if necessary, also others engaging in the treatment of the participants have been properly informed of the Protocol, investigational products and their obligations and duties relating to the Research; To immediately report to the UNIVERSITY all serious adverse events apart from the events, which according to the Protocol or any other document, such as Investigator’s Brochure, do not require immediate reporting, and also to follow the Protocol with respect to the reporting of adverse events and abnormal laboratory values; To ensure accuracy, completeness, reliability, and timeliness of the information submitted to the UNIVERSITY on the case report forms and all required reports, including those in electronic format, and deliver the case report forms and other required reports to the UNIVERSITY; To take care of the registration and notification of information necessary for the invoicing to the financial administration of the Research site at agreed intervals, and To act in co-operation with the UNIVERSITY relating to monitoring visits and audits. Case Report Forms. The Principal Investigator shall fill-up the Case Report Forms ("CRF's"), necessary questionnaires or other required documentation to conduct the Research. All original CRF's will be the sole property of the UNIVERSITY. All other original records of the work completed under this Agreement, including patient medical records, laboratory records and reports, scans, films and information on pre-existing Institution databases will be the property of the UNIVERSITY. Institution will retain a copy of all Research documents for internal research, teaching and archival purposes. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS - The Institution must, if necessary, ensure that all investigators listed in the Research Protocol and conducting the Research provide the UNIVERSITY with all information on their significant financial commitments, such as patent and all other intellectual property rights related to the Research, ownership of shares in the Research Devices.