How are error corrections documented and tracked (i.e., audit trail)?
Errors detected during data management are tagged with QC notes. QC notes, as part of the study database, are tracked in the DataFax journal files as any other data record. The audit trail contains when who added the note, the time/date of the note addition, last modified, and resolution date. Also tracked is the date when the QC note was first sent as part of a QC report to the site.DataFax tracks all version of a form received. Both previously entered data records as well as previously faxed CRF images can be reviewed in a duplicate resolution window. Changes are visually evident.At the site, all form changes, whether in response to a QC report or not, are initialed and dated as per GCP.
