Database Lock Sample Clauses

Database Lock. The Charity will clean and validate the Clinical Trial Results and lock the clinical research database relating to the Clinical Trial as soon as is practicable after the last course of treatment under the Clinical Trial is complete, and will notify the Company promptly after the database is locked.
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Database Lock. Steps to database lock in preparation for interim and/or final analyses include: • Check that all eCRFs have been completed, monitored and signed. • Conduct final programmed edit checks for data logic and consistency. All remaining queries resolved. • Conduct final manual edit checks for logic and consistency. All remaining queries resolved. • Final verification and client approval of all AE coding. • Final verification and client approval of all medication coding. • Final SAE reconciliation between the clinical and safety database. • Final database QC. • Final update of draft data listings provided to client for review and approval. After Sponsor approval to lock, database lock is accomplished by removing write-access to the data. Amarex's Response to Innovate's Request for Proposal 8/3/18 Amarex Clinical Research, LLC Confidential and Proprietary Information Page 19 Final Database Quality Control Amarex will conduct an audit of the analysis data versus eCRF and resolved data queries in order to ensure that all analyzed data accurately portray the site-submitted, Investigator-approved subject data. Information Technology All Amarex systems are in compliance with 21CFR 11 and preserve integrity of electronic records. All systems are setup and tested in compliance to 21 Code of Federal Regulations (CFR), Section 11 and FDA’s 1999 and 2004 Guidance for Computerized Systems Used in Clinical Trials (CSUCT). Amarex’s computer server room is climate controlled with anti-static flooring and secured with a keypad and combination door lock. Access to the room is limited to Amarex’s IT staff. Equipment includes high-density filing systems located in a fire-protected document storage room that is secured by a keypad combination door. All original study-related documents and Case Report Forms will be stored here. Amarex employs a secure, wide-area network with direct Internet access. Amarex’s network is client/server based and is driven by the Microsoft Windows Server System running on Dell PowerEdge series servers. High availability and redundancy features include RAID 1 and 5 hard disk subsystems, gigabit network adaptor teaming, and primary and secondary power supplies. All servers and network equipments are connected to UPS (Uninterruptible Power Supplies) in the event of xxxxx or black outs. Database Backup Procedures Amarex performs daily backups on all of our servers and databases. These backups are stored in a secure offsite facility. Additionally, monthly ful...
Database Lock. Roche Retained IND; Additional Studies in the Roche Retained Field

Related to Database Lock

  • USE OF THIRD PARTY SYSTEMS-LEVEL SOFTWARE State Street and the Fund acknowledge that in connection with the Data Access Services provided under this Addendum, the Fund will have access, through the Data Access Services, to Fund Data and to functions of State Street’s proprietary systems; provided, however that in no event will the Fund have direct access to any third party systems-level software that retrieves data for, stores data from, or otherwise supports the System.

  • Database File The Servicer will provide the Successor Servicer with a magnetic tape (in a format reasonably acceptable to the Indenture Trustee and the Servicer) containing the database file for each Contract (i) as of the Initial Cutoff Date, (ii) the Subsequent Cutoff Date, (iii) thereafter, as of the last day of the preceding Due Period on each Determination Date prior to a Service Transfer and (iv) on and as of the Business Day before the actual commencement of servicing functions by the Successor Servicer following the occurrence of a Service Transfer.

  • Client Data 8.1. Fund (i) will provide or ensure that other Persons provide all Client Data to SS&C ALPS in an electronic format that is acceptable to SS&C ALPS (or as otherwise agreed in writing) and (ii) confirm that each has the right to share such Client Data. As between SS&C ALPS and Fund, all Client Data shall remain the property of the Fund to which such Client Data relate. Client Data shall not be used or disclosed by SS&C ALPS other than in connection with providing the Services and as permitted under Section 11.2. SS&C ALPS shall be permitted to act upon instructions from Management with respect to the disclosure or disposition of Client Data related to Fund, but may refuse to act upon such instructions where it doubts, in good faith, the authenticity or authority of such instructions.

  • Customer Lists We hereby agree that we shall not use any list of your customers which may be obtained in connection with this Agreement for the purpose of solicitation of any product or service without your express written consent. However, nothing in this paragraph or otherwise shall be deemed to prohibit or restrict us or our affiliates in any way from solicitations of any product or service directed at, without limitation, the general public, any segment thereof, or any specific individual, provided such solicitation is not based upon such list.

  • Customer Data Customer shall remain the sole and exclusive owner of all Customer Data and other Confidential Information (as hereinafter defined), regardless of whether such data is maintained on magnetic tape, magnetic disk, or any other storage or processing device. All such Customer Data and other Confidential Information shall, however, be subject to regulation and examination by the appropriate auditors and regulatory agencies to the same extent as if such information were on Customer's premises. "Customer Data" means any and all data and information of any kind or nature submitted to M&I by Customer, or received by M&I on behalf of Customer, in connection with the Services.

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than [***].

  • Software Additional provisions relating to software.

  • Company Software “Company Software” shall mean any software (including software development tools and software embedded in hardware devices, and all updates, upgrades, releases, enhancements and bug fixes) owned, developed (or currently being developed), used, marketed, distributed, licensed or sold by an Acquired Corporation at any time (other than non-customized third-party software that is not incorporated into any Company Product and is licensed to an Acquired Corporation solely in object code form and solely for internal use on a non-exclusive basis).

  • Product Information Galapagos recognizes that by reason of, inter alia, Xxxxxx’x status as an exclusive licensee pursuant to the grants under Section 5.2, Xxxxxx has an interest in Galapagos’ retention in confidence of certain information of Galapagos. Accordingly, during the Term, Galapagos shall, and shall cause its Affiliates and its and their respective officers, directors, employees, and agents to, keep completely confidential, and not publish or otherwise disclose, and not use directly or indirectly for any purpose other than to fulfill Galapagos’ obligations hereunder any Information owned or otherwise Controlled by Galapagos or any of its Affiliates specifically relating to any Licensed Compound or Licensed Product, or the Exploitation of any of the foregoing (the “Product Information”); except to the extent (x) the Product Information is in the public domain through no fault of Galapagos, its Affiliates or any of its or their respective officers, directors, employees, or agents; (y) such disclosure or use is expressly permitted under Section 9.3, or (z) such disclosure or use is otherwise expressly permitted by the terms of this Agreement. For purposes of Section 9.3, Xxxxxx shall be deemed to be the disclosing Party with respect to Product Information under Section 9.3 and Galapagos shall be deemed to be the receiving Party with respect thereto. For further clarification, (i) without limiting this Section 9.1, to the extent Product Information is disclosed by Galapagos to Xxxxxx pursuant to this Agreement, such information shall, subject to the other terms and conditions of this Article 9, also constitute Confidential Information of Galapagos with respect to the use and disclosure of such Information by Galapagos (and Galapagos shall be deemed to be the disclosing Party with respect to Product Information under Section 9.3 and Xxxxxx shall be deemed to be the receiving Party with respect thereto), but (ii) the disclosure by Galapagos to Xxxxxx of Product Information shall not cause such information to cease to be subject to the provisions of this Section 9.1 with respect to the use and disclosure of such Confidential Information by Galapagos. If this Agreement is terminated in its entirety or with respect to the Terminated Territory, this Section 9.1 shall have no continuing force or effect with respect to the use or disclosure of such information solely in connection with the Exploitation of the Licensed Compound or Licensed Product for the benefit of the Terminated Territory, but the Product Information, to the extent disclosed by Xxxxxx to Galapagos hereunder, shall continue to be Confidential Information of Xxxxxx, subject to the terms of Sections 9.2, 9.3, and 9.7 for purposes of the surviving provisions of this Agreement.

  • Licensed Software Section 3.17(f).......................................27

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