VISION™ Tips & Tricks: Utilizing Summaries


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.

VISION™ Tips & Tricks: Layering Searches & Reports

Do you want to view only those Subjects who have been randomized?  Do you also want to only view those Subjects who are of a certain age? The VISION™ Search function is a great way to filter data during your study and multiple searches can be applied to your data! Additionally, Reports can be run on top of applied searches (or already filtered data).
You can navigate to the list of study Subjects and click on the “Search Subjects” button. Any form and field you have access to will appear in the drop-down list to be selected. You can set up as many search criteria as needed, keeping in mind that the criteria must all be met for the search to return any results. You have the option to search for Subjects that meet all criteria by using the “And” radio option. Alternatively you can find Subjects that meet at least one of the criterion by selecting the “Or” radio option.

Figure 1. Displays the Search user interface.  You can add as many search criteria as needed using the drop down selections.  Please note you can also select whether the criteria should work as an “And” or an “Or.”  (And = the results must meet ALL the criteria listed; Or = the results must meet at least one of the criterion.)

Upon clicking the “Apply” button at the bottom of the Search Subjects page, the results, if any, will populate on the Subject list page. Once that search has been applied, go back to Search Subjects and add a new Search and enter new criteria. Click “Apply” again to apply the new criteria on top of the previously applied search, further filtering the Subject population. The layering of searches will always operate as an “or”, meaning that results will be returned if it meets Search 1’s criteria OR Search 2’s criteria.
Any applied Search or Searches can also be layered with Reports. After applying your search(es), click on Reports. The Report results will only display those Subjects that were part of the Search results. Questions? For more information on this and other EDC & CTMS solutions please contact us.

VISION™ Tips & Tricks: Viewing Subject Form State Details

Do you know you can view a Subject’s (or Site’s) forms and their status (aka. Form state) at a glance? Navigate to the Subject List Page. For any given Subject, click on the plus/minus (+/-) icon next to the Subject ID field (see Figure 1). The above is also applicable for Site-level forms!

Figure 1. Displays expanded list of Subject ATL-012-IUM Forms.

This will show this Subject’s listing of applicable forms, if any of those forms have Queries (and the status of those queries), and the *Form State of the forms. Additionally, hover over any of the form icons to view the specific form’s title, form state/status (see Figure 2).

Figure 2. Displays tool tip for the first form within the “Screening” form group. Vitals/Phys Exam has a form state of In-Work and has errors that the user should resolve.

*Form States are used to determine the state of the form. The form icon is color-coded to indicate the status of that form.

  • Blue = In-Work
  • Orange = Submitted for Review (User has signed the form)
  • Yellow = Reviewed (User with appropriate privileges has reviewed the data on the form)
  • Green = Finalized (User with appropriate privileges has finalized the form- edits can no longer be made to the form unless a user with appropriate privileges revers the finalized status)
  • No color indicates that the form is “new” and no data has been entered.
  • A Red form icon indicates that there is an error(s) on the form that must be resolved before the user can Submit for Review.

VISION™ Tips & Tricks: Running Reports on On-Demand Forms

Ever wonder how to run reports for *on-demand forms? Wonder no longer! Navigate to the Subject List Page (or Site if running the report from there), click the Reports (see Figure 1) button towards the bottom of the page.
Reports

Figure 1. Reports button

Select the forms and fields you would like to see in the Report. In this example, I am pulling the Subject ID and the Unscheduled Visit date(s). Figure 2 displays the on-demand Unscheduled Visit forms- this example has two of them.

Figure 2. on-demand Unscheduled Visit forms

For an on-demand form (Unscheduled-Vitals/Phys Exam), you will see an extra field appear next to the form name- this is for the form “number.” You can enter 1 to x, depending on which on-demand form you’d like to view data from. Conversely, you can leave it blank which will pull data from all available on-demand forms.

When pulling from all on-demand forms, if more than one form exists, the data will list out within one cell (see Figure 3).

Figure 3. The Visit Exam Date fields from ALL of the Unscheduled Vitals/Phy Exam appear for Subject ATL-003.

*What’s an on-demand form?

On-demand forms are those forms that can be added as required. The first form is always available and subsequent, identical forms can be added as needed. Common examples of these are unscheduled visits, daily assessments, and serious adverse events forms.