Navigation for Data Entry

Once you log into Vault CDMS, Vault shows the Study, Site, or Casebook listing page, depending on your permissions.

Listing Pages

Vault EDC uses three standard listing pages: Casebook, Site, and Study. All three listing pages are inside the Data Entry tab. Once you open the data entry area, which listing page appears first depends on how many studies and sites you have access to. The Studies and Sites listings pages include all Study and Study Site records you have access to. If you have access to more than one study, you’ll see the Study listing page under the Data Entry tab. You can then click into a Study or use the breadcrumb menu to enter the Site listing page, and then click on a Site to open the Casebook listing page.

If you only have access to one Study, the Data Entry tab defaults to the Site listing page. If you can only access one site, the Data Entry tab opens the Casebook listing page.

Casebook Listing

The Casebook listing page provides a list view of all subjects at a particular site. To view the Casebook listing page, open the Data Entry tab.

For each subject casebook, Vault displays the Subject ID, Last Event Date, Next Event Date, Subject Status, and the Review for Signature requirement.

Casebook Listing Page

Site Listing

If you have access to more than one site, you can use the Site listing page. Vault opens to the Site listing page automatically if you don’t have access to more than one Study. You can return to the Site listing page by clicking the Home icon in the breadcrumb menu in the Data Entry tab. The Site listing page provides a list view of all Sites you have access to in a particular Study. When you navigate to the Site listing page, typically through the breadcrumb menu, Vault EDC displays a grid view of the following information:

  • Site Number
  • Site Name
  • Principal Investigator
  • Subjects
  • Site Status

Site Listing Page

The Last Event Date column displays the last Event with an Event Date. Clicking the Last Event Date value opens the first form in that event.

The Subjects column is a count of all subjects at this particular site. Clicking on this value opens the Casebook listing page.

Study Listing

If you have access to more than one study, you can use the Study listing page. Vault opens to the Study listing page, and you can return to this page by clicking the Home icon in the breadcrumb menu in the Data Entry tab. The Study listing page provides a list view of all studies associated with a Site. The Study listing page displays the following information:

  • Study Number
  • Study Phase (from study_phase__v)
  • Screen Failed %
  • Study Status

Vault calculates the Screen Failed % value by dividing the number of Subjects (casebooks) where the Subject Status is Screen Failure (screen_failure__v) by the total number of Subjects in the Study.

Study Listing Page

If you are involved with a study that uses the Veeva Learning Integration, your ability to access the study is restricted if you haven’t completed the assigned training in Absorb. If you’ve completed the training, your access is Valid. If you haven’t completed the training, your access status is Training Required. Complete the required training in Absorb.

If you’ve completed your training, and Vault hasn’t yet updated your access status, you can click Refresh () to update your access.

Hover over a study’s My Access status to view your Study Role and Training Completion Date. Click View Certificate to access your training certificate in Absorb.

Viewing Listing Pages

There are a few ways for you to adjust the list of object records in a listing page:

  • Click on a column header to sort by that column.
  • Drag the sides of the columns to adjust column width.
  • Filter your listing pages

Filtering Listing Pages

You can filter each listing page using the drop-down menus at the top of the list. To filter, select from a filter drop-down. The filters you choose will remain selected until you log out. You can clear filters by deselecting the checkbox.

Using the Task Bar

You can easily manage your tasks, forms, queries, and messages in the task bar. The task bar displays icons to indicate upcoming work and how close you are to a due date. Depending on your study role, the task bar displays some or all of the tasks described below.

Task Bar in its Initial, Collapsed State

The task bar categorizes tasks into the following:

  • Forms: Overdue forms and incomplete forms
  • Review: Forms that require signature
  • Queries: Open queries that are ready for you to respond to

Note that if you have access to more than one Study, you must select a Study from your Study listing page or the breadcrumb menu, and if you can access more than one Site, you must also select a Site, sbefore Vault will display tasks in the task bar.

Task Icons

Each task has an icon to indicate its task type.

Icon Meaning
Indicates that a form is overdue.
In Progress Icon Indicates in progress, incomplete forms.
Indicates that a submitted form requires your eSignature.
Indicates that a form has open queries.
Indicates that a site's Closeout PDFs are available for review.

Viewing Tasks

You can expand the task bar to view more details about your tasks.

  1. Click the Arrow tab on the task bar. The task bar expands.
    Expanded Task Bar

  2. Click on a task type, for example, Overdue Forms. The task bar displays a list of all subjects with a task of that type. This view includes a task count for each subject.
  3. Click on a subject to view all tasks of the selected type for that subject.
    Subject Selection in the Expanded Task Bar

  4. Click on a task. Vault opens the area in which you can complete the task.
    Task List by Type in the Expanded Task Bar

  5. Click the Arrow tab again to collapse the task bar.

Depending on how many studies, sites, and subjects you have permission to view, Vault may automatically filter your task bar view. If any filters apply, Vault displays them in the task bar, once you select a task type. Note that you cannot remove auto-filters.

Search for a Subject

Vault EDC uses a powerful search engine to help you find object records in your vault. You can perform basic searches from the primary search bar, as well as choosing from type-ahead search results. In the current release, you can only search for Subjects in your vault.

Search for Subjects

Searching in Vault EDC allows you to perform simple queries by searching within object record fields.

To search within object record fields:

  1. Click into the Search field in the primary navigation bar. Vault automatically displays the up to ten (10) potential results. If you’re looking for one of these, click on it from the preview list. If not, continue with the next steps.
  2. Start typing one or more terms in the Search field. When searching for a certain Subject record, you may type the Subject ID value.
  3. Optional: As you type, the preview list updates with each character you enter to suggest up to 10 potential results. If you are looking for one of these, click the result, or press Down and Enter, to open that record.
  4. Press Enter or click the Search icon to see all results.
  5. Click the object record name to view it.

Search Results

The search results page displays your results, with columns for certain fields on the object records. Note that searching will only return object records that you have permission to view.

If there are more than 20 possible search results, Vault EDC paginates your results. Click the Left and Right arrow buttons to move through the search result pages. You can also enter a page number to jump directly to that page of your search results.

When searching for a Subject, the search results page is titled Subjects, and displays columns for the Subject name, Study, Site, Subject Status, and Signature Completed status.

Filtering

You can filter your search results by Subject Status and Review for Signature.

To filter, click into a filter drop-down, and search or select one or more checkboxes. Deselect checkboxes, or click Clear all in the drop-down, to clear your filters.

Filter Search Results

Sorting

You can sort your results by any of the available columns. Click the column header to sort by that value.