ABSTRACT

The biggest job for any data management group running a paper based trial is not the entry of the data into a clinical database — it is checking the data for discrepancies and getting the data cleaned up. Discrepancies are any inconsistencies in the clinical data that require research. Discrepancies may be identified manually at any point during processing when someone reviews either the case report form (CRF) or the data. Most commonly, they are identified by the data management system automatically at entry or after entry via rules defining acceptable data. Discrepancies may also be identified through reporting or analysis in systems external to the data management application.