Automated Data Review
Automated Data Review (ADR), a.k.a. edit checks, are a type of query that are generated automatically by the system. They are study-wide configured rules run on a predetermined schedule (typically nightly) or in real-time to identify discrepant or missing data.
Locating Automated Data Review Findings
Automated Data Review Findings are displayed in the same locations as manual queries issued by Data Managers:
- On subject list screen
- On form level in a procedure
- On form level in a subject log
- On field level
Automated Data Review in Real Time
If real-time edit checks (RTEC) is configured for a study, the edit check will fire as soon as the discrepant data is saved, which is typically within seconds. Please contact your study monitor, data manager or send a support request to crsupport@flatiron.com if you wish to confirm whether RTEC is configured for your study. Otherwise, traditional edit checks do not fire in real-time and can only be reviewed the day after data entry is complete.
- RTECs have a pop-up on the right side of the screen that notifies site users of the Subject ID, Visit, Form and Field that the edit check concerns. This pop-up will remain on the screen for 5 minutes even when site users navigate to another form or subject or site. The popup will be “sticky” and remain in the same position even if the user scrolls up or down the page or navigates to another page. Users have the option to close this pop-up by clicking the X button on the pop-up.
- If multiple queries fire around the same time, the pop-up notification of each query will stack up on top of each other.
- To view details of the query in the pop-up e.g. query message, you will need to navigate to the form/field mentioned in the pop-up and click on the query badge in red to open the query panel on the right side of the screen.
Resolving Automated Data Review Findings
- Traditional Automated Data Review Findings are resolved when the data is corrected and the next scheduled Automated Data Review Findings are run.
- If the Automated Data Review Finding is issued by an RTEC, the automated query will be instantly closed as soon as Site User updates data entry to correct discrepant or missing data.
- Site User does not need to reply to automated queries, unless the query cannot be resolved by updating data entry. In such a case, Site User can reply to the query to explain why data cannot be updated and Data Manger, Monitor or Safety User will need to manually close the automated query.
Note: Automated Data Review queries can be opened on a procedure or subject log entry even if the form is in Submitted or Reviewed status. Once the query is issued, the procedure or subject log entry will be unlocked for additional data entry without changing the submission status. The form will be locked again when the query is answered by Site User/PI or marked as closed by Data Management/Monitor/Safety User.
Multiple Automated Data Review Findings
Similar to standard Data Management Queries, multiple Automated Data Review Findings can be generated per procedure/subject log and individual data entry field.
