database lock

database lock2016-10-22T14:49:22+00:00

database lock

EVIDENCE-BASED MEDICINE

The closing of a database after all of the data in a clinical trial have been reviewed, queries resolved and issues addressed, such that the database cannot be altered in any way.

The amount of time it takes from the last patient visit to database lock is a commonly used indicator of the clinical data management’s efficiency. After the database is locked, the data undergoes statistical analysis before results can be submitted to the FDA.

Reference www.etrials.com/VPK_glossary.pdf-55.htm#P359_130

 

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