Managing Groups

You can create and manage groups in Studio to represent participant groups (ie. cohorts or arms) in the study. Groups can be used to determine the events and/or surveys available for a participant. This can also impact the caregiver or site surveys for a participant.

Accessing Groups

To view and manage groups in a collection, access the collection and select the Groups tab.

Adding a New Type

Groups are defined under their type. For example, the Age Range type includes the groups of “Under 17” and “17 and over”. Each participant must be assigned to one of the Age Range groups.

  1. Select Manage Types. The Manage Types dialog box opens.
  2. Select Add Type.
  3. Enter a Type Label. This is the label that is displayed to site users in Veeva ePRO.
  4. Enter a Type Name. This is the name used to refer to the type in Studio.
  5. Enter a Selection Prompt.The prompt is displayed as instructional text when site users select a participant’s group(s).
  6. Select Save.
  7. Repeat Steps 2 to 6 for all types you want to add, and then close the dialog box.

When you add a new type as part of a study upversion, site staff must be instructed to update all existing participants to assign them to a new group for that type.

Editing a Type

When you edit a type as part of a study upversion, the update is displayed for sites once they activate the new study version.

  1. In the Groups tab, select Manage Types. The Manage Types dialog box opens.
  2. Select the Edit icon Edit Type next to the type you want to edit.
  3. Edit any information you want to change, and select Save.

Deleting a Type

You can’t delete types that have groups or have been used in an approved collection.

  1. Remove the type from any groups that currently use it.
  2. In the Groups tab, select Manage Types. The Manage Types dialog box opens.
  3. Select the Delete button Delete Type next to the Type you want to delete. A confirmation message is displayed.
  4. Select Confirm.

Adding a New Group

Groups are the options that site staff members select under a type. For example, if you add Cohort as a type, you add your actual cohorts, such as Cohort A and Cohort B, as groups. Once defined, you can associate groups with events and/or schedules to make certain events or survey schedules available to certain groups.

  1. In the Groups tab, select Add Group. A new row is added to the Groups table.
  2. Select an option from the Choose a Type menu, or select Add Type in the menu and add a new type.
  3. Enter a Group Label. This value is the label that site users will see for the group in Veeva ePRO.
  4. Enter a Group Name. This is the value that you’ll use to refer to groups in other parts of the collection, such as schedules or rules. See Configuring Schedules and Notifications and Understanding Rules for more information.
  5. Select Save.

Editing a Group

  1. In the Groups tab, select the Edit icon Edit Group next to the group you want to edit on the table.
  2. Edit any information you want to change, and select Save.

Deleting a Group

Once you delete a group, it is removed from the collection and you cannot use it. You can’t delete groups that have been used in an approved collection. If you want to stop using a group that has been in an approved collection, see the Inactivating a Group section.

  1. In the Groups tab, select the Delete button Delete Type icon next to the group you want to delete on the table. A confirmation message is displayed.
  2. Select Remove.

Inactivating a Group

A group that has been in an approved collection can be inactivated. An inactivated group can continue to be used in existing schedules, events, and rules in the collection. Once a site activates the new study version with the inactive group, the group remains selected for existing participants. This ensures that for the ongoing study, existing participants are not affected. However, the group cannot be selected for new participants.

  1. In the Groups tab, select the Inactivate button Inactivate Group next to the group you want to inactivate on the table. A confirmation message is displayed.
  2. Select Inactivate.

Reactivate a Group

An inactive group can be reactivated. Once a site activates the new study version with the reactivated group, the site can select the group for new participants.

  1. In the Groups tab, select the Activate button Activate Group next to the group you want to activate on the table. A confirmation message is displayed.
  2. Select Activate.

See Where a Group Is Used

To see a summary of each schedule this group is assigned to in the Groups tab, select the Info button Group Info next to the group you want to review. The details of where the group is used is displayed.