Data Review, Cleaning and Query Resolution Sample Clauses

Data Review, Cleaning and Query Resolution. ‌ After study data is recorded and submitted to the system, automated edit checks, programmed to ensure the collection of consistent and complete data, may be raised. In addition, post data submission, Philips (or contracted) Monitors, Project Statistician, and/or the Philips Clinical Data Management group will remotely review data listings generated at different time points during the study. Data queries will be generated to resolve any discrepancies or concerns. Data transcribed to eCRFs will be source data verified by the Sponsor/designee(s) on a percentage of the subject population, per a risk-based monitoring approach. Data queries will be generated to resolve any discrepancies or concerns. Designees will be trained on the query issue and resolution process. It is the responsibility of the Site designated personnel to respond to all edits checks and queries. Submitted data as well as all data modifications to submitted data will be documented by the system and available in audit trails. Upon conclusion of the study, after eCRFs are marked as complete and all discrepancies are resolved, the Principal Investigator will be notified to review and the case books and provide electronic signatures.
Sample 1
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