Manual Queries

During the data review process, the reviewer may manually create additional queries to ask the site for clarification on an issue.  The process may be summarized in the following steps:

1. An issue is identified (typically by the monitor or data manager) and a manual query is created and identified by a red flag in MAESTRO. (A data clarification form (“DCF”) is issued if using paper CRFs.)
2. Someone at the site responds to the query by documenting the response either directly in the MAESTRO query or via the DCF.  
3. Another person (sponsor, monitor or designee) will review the query reply and approve (close) the query or reject it (keep it open).  For paper CRFs, the DCF is returned by the site and if the reply is sufficient, the database is changed per the reply supplied on the DCF.

For EDC studies these manual queries are generated by clicking on the “?+” icon adjacent to the field as shown in Figure 1 below.

Figure 1: Manual Query

The screen shown in Figure 2 below appears where the following data is displayed: the Form and Section containing the data point in question, and the Question, or data point at issue and its current value.

To generate the query, the user will enter text into the “Query Text” field.  The “Type” dropdown may provide additional choices on the type of query.  When finished, click the “Create Query” button.  To cancel the process, click the Cancel button.

Figure 2: Manual Query Entry

The query text will be displayed if the query is not successful.  If successful, you will see the message "Query created" as shown in the image below.