Data Lock Point definition

Data Lock Point means, subject to any amendment pursuant to the ICH from time to time, the last date of the period for which information is collected in relation to a Periodic Safety Update Report;
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Data Lock Point means for a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in a PSUR.
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Data Lock Point a restriction of the use of the medicinal product or its suspension. “ICSR” shall mean the document summarizing all available information related to an individual case safety report at a specific point of time. An Individual Case Safety Report (ICSR) is considered valid as soon as the four minimal elements are cumulatively available:
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Examples of Data Lock Point in a sentence

  • CMS shall request the PSUR from NORGINE at least SEVENTY (70) Days in advance of the Data Lock Point (“DLP”).

  • Any information on potentially important safety findings that arise after the Data Lock Point for DSUR while the DSUR is in preparation should be provided to Collaborator as soon as feasible.

  • The Data Lock Point for DSUR will be the last day of the one-year reporting period (the 5th day of December).

  • Collaborator will submit the DSUR no later than 60 calendar days after the Data Lock Point for DSUR.

  • ICD will provide the necessary clinical and/or nonclinical data (not to include any IPI) to enable preparation of the DSUR to Collaborator within one week of the Data Lock Point for DSUR.

  • When possible, CMS should align the data lock point of the report with the International Data Lock Point (EURD list).

  • The submitting Party shall provide the other Party the opportunity to review and comment on any proposed DSUR at Data Lock Point (DLP) plus [***] and prior to its intended finalization for submission to the relevant Regulatory Authority.