Database lock Clause Samples

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 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. 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 ▇▇▇▇▇ or black outs. Amarex performs daily backups on all of our servers and databases. These backups are stored in a secure offsite facility. Additionally, monthly full backups are performed and sent offsite to a secure storage facility where they ...

Database lock. Roche Retained IND; Additional Studies in the Roche Retained Field 7.2.2.1 Roche shall notify Dermira in writing of the occurrence of database lock for the IPF Study within [*****] ([*****]) Business Days of such occurrence. If, after the occurrence of the database lock for the IPF Study, Roche decides to perform additional clinical studies of the Compound or Product in the Roche Retained Field (“Additional Studies”), then Roche shall notify Dermira of such decision within [*****] ([*****]) months after such database lock. 7.2.2.2 In the Roche Retained Field with respect to the Compound and Product, the Parties will collaborate [*****] to prepare for and undertake interactions with applicable Regulatory Authorities, including with respect to developing strategy for meetings with such Regulatory Authorities and attendance of and participating in meetings with such Regulatory Authorities. With respect to a BLA that is submitted to a Regulatory Authority in the Roche Retained Field, Roche shall prepare the content of such BLA and the Parties shall collaborate [*****] to review and finalize such BLA for submission by Dermira, such submission to occur within [*****] ([*****]) Business Days after finalization [*****] Certain portions denoted with an asterisk have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. of the BLA. All costs incurred by the Parties in preparing, submitting and obtaining Regulatory Approval for such BLA shall be [*****].