# Configuring Subject Groups for Complex Trials Complex trials often require more initial operational planning than standard clinical trials to achieve the desired efficiency and flexibility as the study continues. These trials may require the testing of various treatments across different patient populations with multiple study objectives. Veeva Clinical Operations supports these complex clinical trials by allowing users to track subject groups, subject group enrollment metrics, key subject group milestones, and payments for different subject group populations. ## Configuration Overview * Activate the following _Subject Group_ (`study_arm__v`) object types: * _Study Cohort_ (`study_cohort__v`) * _Study Element_ (`study_element__v`) * _Study Part_ (`study_part__v`) * _Substudy_ (`substudy__v`) * Activate the following _Subject Group_ fields on the _Subject_ (`subject__clin`) object and add them to the page layout: * _Subject Arm_ (`arm__v`) * _Study Cohort_ (`study_cohort__v`) * _Study Element_ (`study_element__v`) * _Study Part_ (`study_part__v`) * _Substudy_ (`substudy__v`) * Activate the _Study Country Subject Group_ and _Study Site Subject Group_ fields on the applicable Milestone object types. * Configure the following page layouts: * Add the _Study Country Subject Group_ to the _Study Country_ page layout. * Add the _Study Site Subject Group_ to the _Study Site_ page layout. * Add the _Subject Group Schedule Milestone Schedule_ to the _Subject Group_ page layout. * Configure [user actions](/en/lr/805329/#configuring-subject-group-user-entry-actions) on the appropriate _Subject Group_ lifecycle states. * Configure the [_Apply Milestone Template on State Change_](/en/lr/805329/#subject-group-milestone-template-on-state-change) entry actions on the _Study Country Subject Group, Study Site Subject Group,_ and _Subject Group_ lifecycles. * For Veeva Payments users, configure _Subject Group_ fields on _Fee Template_ (`fee_template__v`) and _Fee_ (`fee__v`) objects for use in Veeva Payments. * Update [permission sets](/en/lr/23647/) and optionally [Dynamic Access Control (DAC)](/en/lr/31824/) to grant users access to the _Subject Group_, _Subject Group Milestone Schedule_, _Study Country Subject Group_, _Study Site Subject Group_, and _Study Product Subject Group_ objects. * Optional: Configure the [Atomic Security](/en/lr/47850/) for the _Track Enrollment Metrics_ and _Create Recruitment Plan_ fields on the _Subject Group Lifecycle_ (`study_arm_lifecycle__v`).
## Configuring User & Entry Actions {#configuring-subject-group-user-entry-actions} ### Seed Subject Groups Configure the **Seed Subject Groups** or **Seed Subject Groups in Bulk** [user action](/en/lr/59885/#user-actions) on the appropriate _Subject Group Lifecycle_ states so that users can create _Study Country_, _Study Site_, and _Study Product_ join records for the _Subject Group_ object. When used, the _Seed Subject Groups_ and _Seed Subject Groups in Bulk_ user actions also trigger the creation of new _Study Country_, _Study Site_, and _Study Procedure_ join records when a user adds new countries, sites, and procedures to the _Study_. ### Seed Metrics Records Configure the **Seed Metrics Records** user action on the appropriate _Subject Group Lifecycle_ states so that users can create a set of _Metric_ records for the _Subject Group_. ### Create Metrics Over Time Records Configure the **Create Metrics Over Time Records** user action on the appropriate _Subject Group Lifecycle_ states so that users can create a set of _Metrics Over Time_ records for the _Subject Group_. ### Apply Milestone Template on State Change {#subject-group-milestone-template-on-state-change} Configure the **Apply Milestone Template on State Change** entry action on the appropriate lifecycle states for the _Study Country Subject Group_, _Study Site Subject Group_, and _Subject Group_ [lifecycles](/en/lr/30683/) so that Vault can automatically release _Subject Group Milestones_ when a _Subject Group_-related object enters the specified lifecycle state. Vault will not release _Subject Group Milestones_ if you do not configure this entry action.  Additionally, configure any state change user actions for the _Study Country Subject Group_, _Study Site Subject Group_, and _Subject Group_ lifecycles necessary to trigger the _Apply Milestone Template on State Change_ entry action. ## Related Permissions You can complete all steps in this article and the [Using Subject Groups for Complex Clinical Trials ](/en/lr/80113/) article with the standard Business Admin, System Admin, or Vault Owner profile. If your Vault uses custom security profiles, your profile must have the following [permissions](/en/lr/23647/) to work with _Subject Groups_: | Permission Type | Permission | Effect | | ----- | ----- | ----- | | Security Profile | Admin: Objects: Subject Group: Read, Create, Edit, Delete | Ability to view, create, edit, and delete _Subject Groups_| | Security Profile | Admin: Objects: Study Country Subject Group: Read, Create, Edit, Delete | Ability to view, create, edit, and delete _Study Country Subject Groups_ | | Security Profile | Admin: Objects: Study Site Subject Group: Read, Create, Edit, Delete | Ability to view, create, edit, and delete _Study Site Subject Groups_ | | Security Profile | Admin: Objects: Study Product Subject Group: Read, Create, Edit, Delete | Ability to view, create, edit, and delete _Study Product Subject Groups_ | | Security Profile | Admin: Objects: Subject Group Milestone Schedule: Read, Create, Edit, Delete | Ability to view, create, edit, and delete _Subject Group Milestone Schedules_ |