Device Accountability Clause Samples
Device Accountability. All of the valves and valve delivery catheters used in the study will be maintained in a secure location at the investigational site until used or returned to the sponsor. Study devices will only be used under the Investigator’s supervision in study participants. The Investigator will not supply the study device to any person not authorized under this protocol to receive it. The Investigator shall maintain accurate device accounting records including quantity and date of receipt, person in receipt, lot number, use or disposition, participant identification associated with device, date of expiration (if applicable) and quantity and date of any devices returned to the Sponsor.
Device Accountability. The Sponsor will only distribute the investigational device, LiquiBand FIX8®, to qualified investigators and sites that are part of the clinical investigation. The Sponsor will maintain complete, current and accurate records pertaining to the distribution of the investigational devices and follow record keeping requirements in accordance with applicable regulations. All LiquiBand FIX8® investigational devices must be stored in a secure storage area to which only the Investigator and/or designated study staff will have access. The Investigator is responsible for device accountability at the study site. The Investigator may assign the responsibility for the device accountability to an appropriate study staff member, but remains the final responsible person. The Investigator must ensure that the devices are used only in accordance with the investigational plan. The Investigator is responsible for maintenance of adequate records of the receipt, disposition (administration to each subject as well as any device component that is opened but not used). Used devices (excluding malfunctioning devices) may be disposed of according to site disposal practices. Use of the investigational device outside of the investigational plan is strictly forbidden and may constitute grounds for removal of the investigator/site from the study.
Device Accountability. Neurologix shall provide device accountability records (as described in the protocol) to Medtronic on a calendar quarter basis, beginning during the quarter in which the first PD Clinical Study procedure is performed. The data sent on a quarterly basis does not need to be monitored.
Device Accountability