STUDY TERMINATION AND SITE CLOSURE Sample Clauses

STUDY TERMINATION AND SITE CLOSURE. Upon completion of the study, the following activities, when applicable, must be conducted by the Study Monitor in conjunction with the Investigator, as appropriate: • Return of all study data to the Sponsor or its designee • Data clarifications and/or resolutions • Accounting, reconciliation, and final disposition of used and unused study drug • Review of site study records for completeness; and • Shipment of blood samples to the clinical laboratory. Lupin Inc. reserves the right to temporarily suspend or prematurely terminate this study for any reason. If the study is suspended or terminated for safety reason(s), Lupin Inc. will promptly inform the Investigator, and will also inform the regulatory authorities of the suspension or termination of the study and the reason(s) for the action. The Investigator is responsible for promptly informing the IRB/IEC, and providing the reason(s) for the suspension or termination of the study. If the study is prematurely discontinued, all study data must be returned to the Sponsor or its designee. In addition, the site must conduct final disposition of all unused study drug in accordance with Lupin Inc. procedures for the study.
Sample 1
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Related to STUDY TERMINATION AND SITE CLOSURE

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  • Termination and Data Destruction Upon Project Close-out, the Requester and Approved Users agree to destroy all copies, versions, and Data Derivatives of the dataset(s) retrieved from NIH-designated controlled-access databases, on both local servers and hardware, and if cloud computing was used, delete the data and cloud images from cloud computing provider storage, virtual and physical machines, databases, and random access archives, in accord with the NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy. However, the Requester may retain these data as necessary to comply with any institutional policies (e.g., scientific data retention policy), law, and scientific transparency expectations for disseminated research results, and/or journal policies. A Requester who retains data for any of these purposes continues to be a xxxxxxx of the data and is responsible for the management of the retained data in accordance with the NIH Security Best Practices for ControlledAccess Data Subject to the NIH Genomic Data Sharing (GDS) Policy, and any institutional policies. Any retained data may only be used by the PI and Requester to support the findings (e.g., validation) resulting from the research described in the DAR that was submitted by the Requester and approved by NIH. The data may not be used to answer any additional research questions, even if they are within the scope of the approved Data Access Request, unless the Requester submits a new DAR and is approved by NIH to conduct the additional research. If a Requester retains data for any of these purposes, the relevant portions of Terms 4, 5, 6, 7, 8, and 12 remain in effect after termination of this Data Use Certification Agreement. These terms remain in effect until the data is destroyed.

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