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Extra resources for The Distribution of Correlation Ratios Calculated from Random Data
Chapter 4 discusses the specification, testing, and building of the database or EDC application in detail. Quality assurance for database design Use of standards and reuse of similar modules are the best ways to ensure quality in database design. Every time a new database object is used and put into production, it opens up a chance for design errors. Even when standard objects are used for new studies, the designer may choose the wrong object. Database design is a critical step in conducting a study and a policy of “do and review” should be in place.
Even a little bit of standardization can go a long way to reducing setup time and the associated validation of the database application. In all companies, true standards can only be achieved when the CRF or eCRF module is standardized as well. The most successful standardization efforts involve clinical teams, programmers, and statisticians working with data management and within database systems restrictions. Standardization effort will not work unless all department managers commit to following the standards that are developed!
Fm Page 34 Wednesday, June 21, 2006 3:42 PM 34 Practical guide to clinical data management, second edition impact production timelines as CRFs stack up for paper studies or a new version of an EDC application must be released. Just as programmers on critical applications in other industries have software code review, database designs should always be reviewed by a second person. Even the smallest of data management groups should be able to arrange for some level of review as it is not practical or wise to have only one person able to do a particular task.