Common View Configuration Details

This article contains explanations about some common View Definition configurations. With the “Mapping Adverse Events” example, you can see an overview of an end-to-end view configuration. Following that example, you can review explanations of different issues that may arise with referencing repeating Forms and Item Groups in your view.

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Example Configuration: Mapping Adverse Events

Over the course of your Study, you may want to map the Adverse Event form to export that data for later review. You can easily configure a View Definition to collect all data related to Adverse Events in your Study.

Your study uses a single Adverse Events repeating form within a Common Log Forms event. That form contains the following Items in the ig.AE item group:

  • AETERM (Text) - What is the adverse event term?
  • AESTDTC (Date/Time) - Start Date/Time of Adverse Event
  • AEENDTC (Date/Time) - End Date/Time of Adverse Event
  • AEONGO (Codelist) - Is the adverse event ongoing?
  • AESEV (Codelist) - Severity
  • AETOXG (Text) - Standard Toxicity Grade
  • AESER (Codelist) - Is the adverse event serious?

First, create a new View Definition and View Set Definition:

  1. From Studio > View Sets, click + New View Set to create a new View Set Definition.
  2. For this example, “AE View Set” for the View Set Name.
  3. Click into the View Set Definition.
  4. Click + New View to create a new View Definition.
  5. For this example, enter “AE Listing” for the View Name

Reference Columns

Now, you can add the following reference Column Definitions to your view. You must add reference columns before you can add Item Groups to your view. See Creating Views in Studio for details about adding columns to a view.

Each of these reference columns is a Direct type.

Column Name Column Mapping Object Column Mapping Field Object Identifier
Study study__v (Study) name__v (Name) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}
Country study_country__v (Study Country) name__v (Name) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}
Site site__v (Study Site) name__v (Name) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}
Subject ID subject__v (Subject) name__v (Name) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}
Event Date event__v (Event) event_date__v (Event Date) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}
Event event__v (Event) label__v (Label) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}
Form form__v (Form) label__v (Label) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}
Form Sequence form__v (Form) form_seq__v (Form Sequence) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}
Item Group item_group__v (Item Group) label__v (Label) {Common Log Forms/Adverse Events/ig.Adverse Event/AETERM}

You can also add an additional Static-type reference column for the SDTM Domain.

Column Name Value
SDTM Domain AE

The last column to add before adding the Item Group is a derived, Export Run column. In the exported CSV, this column will show the time and date that the Data Export job ran.

Column Name Expression
Export Run now()

Item Value Columns (Clinical Data Points)

You can use the Add Item Group button to automatically create a Column Definition for each Item in an Item Definition. You can also choose to manually create these columns.

After clicking the Add Item Group button and choosing the identifiers for the item group {Common Log Forms/Adverse Events/ig.AE}, Vault adds a Direct-type Column Definition to your view for each Item in the Item Group.

Vault adds those Column Definitions diagonally (on a new row, but with the columns beginning at the end of the existing reference columns). In the current release, Vault does not support including blank, unmapped cells in a View Definition. Instead, Vault adds Column Mapping Definitions referencing the Source Type field on the Item object. This field is automatically blank on each Item Record, and so it will result in an empty cell in the exported CSV file.

Saving the View Definition

After you finish reviewing your View Definition and reordering any columns, click Save. Vault saves your View Definition, and it is now available for use with Data Export jobs.

Repeating Form & Item Group Recommendations

Sequence Number Reference Column

We recommend that you include a Sequence Number column in View Definitions that reference repeating Forms or Item Groups. This allows you to identify the sequence associated with each Form or Item Group’s data.

Create a Direct-type column mapping to the Form (form__v) or Item Group (item_group__v) object and the Form Sequence (form_seq__v) or Item Group Sequence (item_group_seq__v) field. Then select the correct set of object identifiers.

Referencing Multiple Repeating Item Groups or Forms

A common pitfall during view configuration is to have multiple mappings referencing repeating Item Groups on the same Column Mapping Row. This results in either a failed Data Export job or an indecipherable CSV file with duplicate rows. This is because Vault cannot reconcile repeated data entries across separate repeated Item Groups on a single row.

Instead, create a new row for each set of Items in a repeating Item Group. Note that you can use a single row with multiple non-repeating Item Group references and one repeating Item Group reference.

Codes & Decodes

When a mapping references a Codelist Item, using the mapping of item__v (object) and value__v (field) returns the coded value for the Item, which reviewers may find difficult to interpret.

You can also reference the decoded value to make your view easier to read. To reference the decoded value, use the codelist_item_def__v (object) and label__v (field) mapping.

Item Naming & Data Export

If your Study contains Item Definitions with the following values used as Names or OIDs, Data Export jobs may fail do to errors during SAS conversion.

  • Study ID
  • Country
  • Site
  • Subject ID
  • Event
  • Event Date
  • Event Sequence
  • Form
  • Form Sequence
  • Item Group
  • Item Group Sequence

You can easily reference these data points using the standard Vault EDC objects and fields containing that data (for example, the Event object and its Event Date field).