Configuring Reasons for Change

You can specify the options for any dialog that uses a Reason for Change. Vault EDC stores these values in the Change Reason Configuration object (change_reason_config__v). Each Change Reason Configuration object record represents a value in the Reason for Change drop-down menu. Users select from the Reason for Change drop-down in the Intentionally Left Blank, Did Not Occur, and Change Reason dialogs.

Creating a New Reason

To add a new reason for change option:

  1. Navigate to the Change Reason Configuration object in Admin > Business Admin.
  2. Click Create.
  3. Enter a Name. The text you enter here displays in the drop-down when a user is selecting a change reason.
  4. Fill the required fields.
  5. Select a Change Reason Type. This value determines at which levels this reason applies to (Subject, Event, Form, Item Group, or Item).
  6. Select a Change Reason Subtype. This value determines which dialogs this reason displays in (Change Reason, Did Not Occur, Intentionally Left Blank, or Deletion).
  7. Click Save.

Updating a Reason Label

Vault EDC includes several default Change Reason Configuration records. Note that for these default records, Vault EDC does not display the record’s Name, and instead displays a translated value. You can update those labels, as well as labels for custom Change Reason Configuration records, using Bulk Translation. By default, Vault EDC displays the Name value you entered when creating your Change Reason Configuration record.

To update a label, you first export a translation file CSV:

  1. Navigate to Admin > Settings > Language & Region Settings.
  2. Scroll to the Bulk Translation section.
  3. Choose Field Labels for Select Items to Translate.
  4. Choose your vault’s language for Export Translation File.
  5. Click Export.
  6. Vault automatically begins a download of a translation file CSV.

Then, make your label changes in that CSV file:

  1. When the download is complete, open the CSV file in your editor of choice.
  2. Locate your new Change Reason Configuration. Scroll to (or search for) the chng_reason_cfg__v section of the CSV. You can identify your new record by its ID.
  3. Edit the value in the Translated Label column. This value will display to your users.
  4. Save the CSV.

Lastly, import the updated CSV back into your vault to use the updated labels.

  1. Return to the Bulk Translation section of Admin > Settings > Language & Region Settings.
  2. Click Choose for your Import Translation File.
  3. Browse to and select your updated CSV.
  4. Click Import.

See About Language & Region Settings for more details about translation in Vault EDC.

How to Enable “Other (please specify)”

You can also choose to allow your users to select Other (please specify) as a Reason for Change when marking a Form or Item as Intentionally Left Blank, or when changing any data from what it was originally saved as (for example, editing a Form or an Event Date). This reason adds a text field to the dialog, in which the user can enter their own reason.

To enable the Other (please specify) option:

  1. Navigate to the Study Configuration object in Admin > Business Admin.
  2. Click into your Study.
  3. Click Edit.
  4. Select the Yes radio button for Enable Other Specify - Reason for Change and Enable Other Specify - Left Blank. You can enable one or both of these.
  5. Click Save.

The Other (please specify) change reason will now display whenever a user marks a Form or Item as Intentionally Left Blank or edits a Form or Item.

Activating & Inactivating a Reason

You may want to hide a change reason. You can accomplish this without deleting a Change Reason Configuration record by setting a Change Reason Configuration as Inactive.

To inactivate a  Change Reason Configuration record:

  1. Navigate to the Change Reason Configuration object in Admin > Business Admin.
  2. Click into the Change Reason Configuration record.
  3. Click Edit.
  4. In the Change Reason Status field, select Inactive.
  5. Click Save.

That Change Reason Configuration is now inactive, and it will not display to your data entry users.

You can later choose to activate that Change Reason Configuration record to display it again. To activate the record, edit the Change Reason Configuration record and choose Active in the Status field.

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the standard Vault Owner or Design security profiles can perform the actions described above by default. If your vault uses custom security profiles, you must have the permissions described in the Profile Permissions table.

Profile Permissions

Users with the Vault Owner security profile can perform the actions above. If your vault uses custom security profiles, you must have the following permissions:

Type Permission Controls
Security Profile Objects: Change Reason Configuration: Create, Edit Ability to create and edit records for the Change Reason Configuration object
Security Profile Objects: Study Configuration: Edit Ability to edit Study Configuration records to enable and disable Other (please specify).
Security Profile Admin: Language: Edit Ability to export and import translation files from Admin > Settings > Language & Region Settings

Learn more about permission sets.