Investigational Device Sample Clauses

The Investigational Device clause defines and governs the use of a medical device that is being tested or evaluated in a clinical study but has not yet received full regulatory approval. This clause typically outlines the device's intended use, restrictions on its distribution, and requirements for handling, monitoring, and reporting any issues or adverse events related to its use during the study. By clearly specifying these parameters, the clause ensures regulatory compliance and participant safety, while also clarifying the responsibilities of all parties involved in the research.
Investigational Device. The Sponsor/CRO, the Institution and the Principal Investigator agree to take all measures that might be required for lawful importation into the Czech Republic of all parts of the Device to be used in the Clinical Trials, including among other things obtaining all the necessary authorisation from the Czech customs authorities. The Institution and the Principal Investigator undertake not to use the Device other than as specifically stipulated in this Contract or the relevant Clinical Investigation Plan and that only the Principal Investigator or any Sub-Investigator(s) approved in writing by CRO/Sponsor shall use the Device. Institution and the Principal Investigator shall not, nor permit any third party to, attempt to alter, open, change or analyse, decompile, disassemble, reverse engineer (or the like) the Device. Institution shall keep traceability and accountability of all Devices. Institution and Principal Investigator will keep the Device in storage facilities in accordance with the CRO´s/Sponsor's instructions and with Applicable Laws, in particular Decree No. 62/2015 Coll., on Implementation of Certain Provisions of the Act on Medical Devices, as amended Should any Device be damaged for any reason, the Institution and Principal Investigator shall promptly return it to the Sponsor. Upon the earlier of, completion of all of the Clinical Trials and/or termination or expiry of this Contract, or at the request of the Sponsor, all units of the Device shall be immediately returned to the Sponsor. The Principal Investigator shall notify the Sponsor immediately with regard to any defects or faults with respect to the Device. The Contracting Parties hereby note that the Device and all other materials and information provided under this Contract are of an experimental nature and are to be used for purposes of the Clinical Trials only. The Sponsor makes no warranties, express or implied, including and without limitation any of the implied warranties of merchantability, fitness for a particular purpose and non- infringement, regarding the Device. komisí a SÚKLem, a který obsahuje a uvádí v platnost všechny prvky uvedené v příslušném Plánu klinické zkoušky a veškeré další informace vyžadované Platnými právními předpisy.
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Investigational Device. The Sponsor, the Institution and the Principal Investigator agree to take all measures required for lawful importation into the Czech Republic of all units of the Device to be used in the Clinical Trials, including obtaining all the necessary authorisation from the Czech customs authorities. The Institution and the Principal Investigator undertake not to use the Device other than as specifically stipulated in this Contract or the relevant Clinical Investigation Plan. Following completion of all of the Clinical Trials and termination or expiry of this Contract, or at the request of the Sponsor, all units of the Device currently held at the Institution shall be immediately returned to the Sponsor. The Principal Investigator shall notify the Sponsor immediately with regard to any defects or faults with respect to the Device. The Contracting Parties hereby note that the Device and all other materials and information provided under this Contract are of an experimental nature and are to be used for purposes of the Clinical Trials only.
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Investigational Device. Sponsor shall provide all Devices necessary for conduct of the Trial to the Clinical Team at no charge, pursuant to the terms set forth below and in the Agreement. The parties acknowledge that the Device is comprised of multiple components, including hardware, software, and disposables. The term “Device” refers to the hardware, software and/or disposables, as applicable. Hospital and Clinical Team shall not seek or retain payment from any patient, third-party health insurer or any other person or entity for the Device.
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Investigational Device. The definition of an investigational device is a device that is assessed in a clinical investigation, MDR Article 2
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Investigational Device. (LiquiBand FIX8®)‌
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Related to Investigational Device

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Investigational Services This plan covers certain experimental or investigational services as described in this section. This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.

  • Background Investigation The BOARD is prohibited from knowingly employing a person who has been convicted of committing or attempting to commit certain criminal offenses. If the required criminal background investigation is not completed at the time this Contract is signed, and the subsequent investigation report reveals that there has been a prohibited conviction, this Contract shall immediately become null and void.

  • Investigation and Prevention DST shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to: (A) cooperate with Fund in its efforts to comply with statutory notice or other legal obligations applicable to Fund or its clients arising out of unauthorized access and to seek injunctive or other equitable relief; (B) cooperate with Fund in litigation and investigations against third parties reasonably necessary to protect its proprietary rights; and (C) take reasonable actions necessary to mitigate loss from any such authorized access.

  • Grievance Investigation The Employer agrees to supply to the Union the names of all applicants for a vacancy, or new position in the course of a grievance investigation.