Database Lock definition

Database Lock means the database lock of the Study Data after Study Completion.

Database Lock means, with respect to each Combined Therapy Trial, such actions as are taken with approval of the JDC to prevent any modification to the database of Study Data generated in the course of such Combined Therapy Trial.

Database Lock means when the clinical trial database for the [***] is locked to further modifications (including additions, deletions or alterations of data).

Examples of Database Lock in a sentence

• At the end of the trial, prior to analysis, Priment SOP Database Lock, Unlock and Closure will be followed.

• All final, planned analyses identified in this SAP will be performed by Quintiles Biostatistics following Sponsor Authorization of this Statistical Analysis Plan, Database Lock, Sponsor Authorization of Analysis Sets and Unblinding of Treatment.

• The Long Island DMC will conduct final data quality assurance checks and “lock” the study database from further modification in accordance with the Database Lock SOP developed by the DMAS.

• Database services and support will be delivered through a contract signed by Sealed Envelope and UCL.PRIMENT SOPs Validating Sealed Envelope Systems and Change Control for Sealed Envelope Systems will be followed to set up and manage changes to the trial database.At the end of the trial, prior to analysis, PRIMENT SOP Database Lock, Unlock and Closure will be followed.

• Any changes from the analyses planned in SAP will be detailed in the Clinical Study Report (CSR).Prior to Database Lock, a Final Review of Data and TLFs Meeting will be held to allow a review of the clinical trial data and to verify the data that will be used for analysis set classification.

More Definitions of Database Lock

Database Lock means, with respect to each Collaboration Study, such actions as are taken with approval of the JDC to prevent any modification to the database of Study Data generated in the course of such Collaboration Study.

Database Lock means the locking of a Study database maintained by Sponsor that includes the data from the Case Report Forms, whereby no further changes are allowed thereafter.

Database Lock means after data collection has been completed in a clinical trial, including follow up of all participants as described in the clinical trial protocol, data quality and validation exercises are undertaken. After this, the database is “locked” so no further changes can be made to clinical trial data and the data are then able to be extracted from the database for analysis.

Database Lock means, with respect to any Clinical Trial, the date on which the database(s) containing the applicable clinical trial data is determined to be complete and locked in order to permit the analysis of the primary and secondary endpoints of such Clinical Trial. ActiveUS 144208420v.18

Database Lock means that all Sub-Study data has been received and processed, all queries have been resolved, all external data (for example, lab results) have been integrated into the main Sub-Study database, the completion of the final quality audit ensuring that all Sub-Study data is present, correspondent and accurate and that the edit access of the Sub-Study database has been removed.

Database Lock means, with respect to the Next Trial, the stage in which the clinical trial database is ready for code opening and analysis of the trial results, as described in Schedule 1.64(a).

Database Lock means the date upon which the final database lock has occurred following completion of the last patient dosing with respect to the Phase III Clinical Trial.