Common use of Site Evaluation Clause in Contracts

Site Evaluation. The INSTITUTION will conduct an evaluation of the planned facilities to be used by the INSTITUTION for the Study before the performance of the Study and before implementation of the Study. Responsibilities of the Sponsor. To provide the INSTITUTION with the necessary background information needed for the appropriate and safe conduct of the Study; To ensure necessary training and orientation of the investigators and other personnel of the INSTITUTION involved in the Study in order to conduct the Study in accordance with the protocol; To register the Study into an open international publication register according to common practice before starting the patient recruitment; To inform the INSTITUTION of the completion of the Study; To provide training for medical personnel who will conduct the pulse oximetry screening; To designate a research assistant to conduct data collection on site; To provide the INSTITUTION with the data and documents needed for conducting the Study and guaranteeing the safety of the participants. The data and documents provided by the Sponsor may be used solely for the conduct of this Study in accordance with this agreement. To act as the employer of the investigators and other personnel conducting the Study; To ensure that during the term of Study set forth in this agreement, the Investigators engaging in the Study do not initiate any other clinical Study at the Study site, which would delay recruitment of participants for this Study; To ensure that qualified and instructed personnel and adequate equipment are available for the Study and that the Study may also in other respects be conducted in safe conditions; To allow participation of the Investigators and when appropriate/needed also other personnel conducting the Study in Investigators meetings and other education arranged by the Sponsor; To ensure that the Investigators 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 that the participants are not simultaneously involved in any other clinical trials and that they are not participants to any investigations differing from the Study protocol; To allow monitoring and auditing at the Study site to be conducted by the Sponsor through its representatives, 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 Sponsor concerning the conduct of the clinical Study; To ensure that qualified and instructed personnel, as well as adequate equipment are available for the Study, and that the Study can also in all other respects be conducted under safe conditions; To conduct the Study in accordance with the protocol as approved by the UP Manila Ethics Committee including potential approved amendments thereto; To immediately notify the Sponsor 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 Study and have received sufficient information of the Study and benefits, risks, and disadvantages related thereto for giving the consent; To ensure that all the persons assisting in the Study 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 Study; To immediately report to the Sponsor 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 Sponsor 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 Sponsor; To take care of the registration and notification of information necessary for the invoicing to the financial administration of the Study site at agreed intervals, and To act in co-operation with the Sponsor relating to monitoring visits and audits.