How are data queries are communicated to the study/trial sites?
DataFax includes the capability of tagging data fields with QC notes. These notes can be added either manually during visual review (triggered by an illegal field, for example), or added in batch mode by external edit checks. QC notes are contained as part of the study database and are part of the DataFax audit trail. Fields with unresolved QC notes are indicated as blue on the data entry screen.Typically every two weeks a DataFax data cleaning process is run to generate a QC report that bundles all of the QC notes on a per site basis. This report is emailed as a PDF attachment to the responsible site personnel at the study sites. The report can be generated as needed, including more or less frequently based on study need. QC reports sent to the sites include a list of patients, forms, visits, and problem descriptions.The QC report process can be run more or less frequently based on study and client need.
