Managing Groups

You can create and manage groups in Studio to represent participant groups (such as cohorts or arms) in the study. Groups can be used to determine the events and/or surveys available for a participant. This selection can also impact the caregiver or site surveys for a participant. Groups can be configured to be assigned either at the time of participant creation or when specific events are scheduled for participants.

Accessing Groups

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

Working with Group Types

Adding a New Group Type

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

  1. Select Manage Group Types. The Manage Group Types dialog box opens.
  2. Select Add Type.
  3. Enter a Type Label. This label is displayed to site users in Veeva eCOA.
  4. Enter a Type Name. This name is 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.

By default, sites are prompted to assign participants to group types when participants are created. Alternatively, you can prompt for a group type to be assigned at a particular event by enabling event-triggered group assignment. See Creating Scheduled Events on the Managing Events page for more information.

Editing a Group 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 the Edit icon Edit Type next to the type you want to edit.
  2. Edit any information you want to change, and select Save.

Deleting a Group Type

You cannot delete types that have groups or have been used in an approved collection. If you cannot delete a type that you want to stop using, remove the type’s groups from all events and schedules and inactivate all of the type’s groups. Then sites will no longer be prompted to assign participants to the group type.

Complete the following steps to delete a group type:

  1. In the Groups tab, delete any groups from the type you want to delete.
  2. Select Manage Group Types. The Manage Group Types dialog box opens.
  3. Select the Delete icon Delete Type next to the Type you want to delete. A confirmation message is displayed.
  4. Select Confirm.

Working With Groups

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 of participants.

  1. In the Groups tab, select Add Group. The Add Group panel opens.
  2. Select an option from the Type Label menu, or select Add Type from 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 eCOA.
  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 Creating a Criteria Check Rule Template for more information.
  5. Select Save.

You can limit what a group has access to after you create it by looking into the following processes:

  • To specify that only some events apply to the group, set this group as an Applicable Group for the events. See Creating New Events on the Managing Events page for more information.
  • If the group should only get some surveys, add the group to the applicable schedule. See Configuring Schedules and Notifications for more information.

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. The system prevents you from deleting groups for the following reasons:

  • The group has been used in an approved collection. If you want to stop using a group that has been in an approved collection, see the Deactivating a Group section.
  • The group is referenced by events or schedules.
  • The group is the last group in a group type that has an assignment triggered by an event.

Complete the following steps to delete a group:

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

Deactivating a Group

A group that has been used in an approved collection can be deactivated. A deactivated 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 deactive 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 Deactivate icon Inactivate Group next to the group you want to inactivate on the table. A confirmation message is displayed.
  2. Select Deactivate.

Reactivating 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 icon () next to the group you want to activate on the table. A confirmation message is displayed.
  2. Select Activate.

See Group Details

You can see a summary of each schedule this group is assigned to and which events apply to the group. In the Groups tab, select the Where Used icon Group Info next to the group you want to review. The details of where the group is used are displayed.