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All database validation and user acceptance documentation should be readily available to the study personnel to ensure that all database functions being performed on a study have been validated for quality and reliability. Additionally, consideration should be given to ensure that project team access to clinical data is sufficient to expedite efficient and high-quality interim reporting, data-metrics evaluation, and safety-reporting requirements (see the Safety Data Management and Reporting chapter and the Measuring Data Quality chapter).
The need for thorough validation and trial database design is even more critical for trials utilizing electronic data collection. If a software malfunction or unintended loss of information occurs, data collected on paper CRFs can be re-entered. Because electronic data collection eliminates paper documents as an intermediary step between the study observations and the database, it is critical that database validation and reliability issues are resolved on the validated system prior to the entry of any study data. As electronic data entry moves closer to the point of patient care, electronic information more often will be the source data and, as such, require protection and secure warehousing.
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