Did you know that each VISION™ study comes with a set of standard Summaries?  They aggregate Subject and Site-level data, enabling faster monitoring and data validation. Standard Subject-level summaries may include Subject Status, Form Status, Query Details, and Comments (Note to Field).  Standard Site-level summaries may include Site Status, Enrollment, Form Status, Queries and Comments (Note to Field). Custom summaries are also available upon request (and include, but are not limited to Adverse Events, Deviations, Note to File, etc.).

 

To access a Subject or Site Summary, navigate to the Subject or Site list page and Click the “Summaries” button in the footer of the page.
Summaries
Also, please note that if any Searches or Filters have been applied, the Summary data will only display the filtered data set. At the Subject level, you can view Summaries for all sites, or a specific site by specifying in the site dropdown (see Figure 1).

Figure 1. Site selection dropdown can be found in the page header.

You can then narrow the scope of the subjects you’re viewing by applying search criteria (see Figure 2).

Figure 2. Adding Search criteria can help narrow the scope.

See our Tips and Tricks on Layering Data Searches for more details on applying search criteria.

Below is a table of examples found in VISION™:

Summary cohortSummary dataDescription of Summary
SubjectSubject Visit StatusShows the most important dates per subject. (Study visit dates, study completion dates, etc.)
SubjectForm StatusShows the # of forms in-work, in-review, reviewed, finalized for each subject. Also shows the # of unresolved, resolved and reviewed queries per subject.
SubjectQuery Details Summary contains two sub-tabs, one for "Unresolved Queries" and one for "All Queries." Details include subject ID, form/field query was entered on, date, who entered the query, the query, and the time it took to resolve the query (or the time it has been open).
Subject and SiteNote to FieldShows an aggregate of the notes made to subject (or site) fields
SiteSite StatusShows aggregate enrollment by gender, screen failures, and completed study status. It can also display Form and Query status.
SiteEnrollmentShows a graph and/or table of expected versus actual enrollment per site.
SiteQuery GraphShows total versus unresolved queries. Excellent for a quick view of query status overall and for site comparison.

Please contact your Prelude Project Manager for more details or questions on this article.