Description: Audit trail review (ATR) in clinical trials is the systematic, risk-based examination of audit trail data and relevant metadata to identify changes, patterns, or activities that may require further investigation. Clinical trial systems continuously record how data are created, corrected, reviewed, queried and updated. Over the course of a study, this can generate a substantial history of activity across subjects, sites, visits, forms, fields and users. The audit trail preserves that history, but simply having the history available does not tell reviewers which activity matters. A corrected value may be completely routine. The same type of correction occurring repeatedly across critical fields, at one site, or after data have already been reviewed may deserve closer attention. This is where audit trail review becomes important. The objective is to examine audit activity in context and identify individual events or patterns that may require further review.
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Tag: edc software