Complex clinical 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)
- Study Cohort (
- 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)
- Subject Arm (
- 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 on the appropriate Subject Group lifecycle states.
- Configure the Apply 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 and optionally Dynamic Access Control (DAC) 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 for the Track Enrollment Metrics and Create Recruitment Plan fields on the Subject Group Lifecycle (
study_arm_lifecycle__v).
Note: Some Vaults may contain the Study Arm (study_arm__v) object, which has now been updated to the name Subject Group. If your Vault contains the Study Arm object, update the object label to Subject Group. You must also update the name for the corresponding Study Arm lifecycle (study_arm_lifecycle__v) to Subject Group Lifecycle and the Arm field (arm__v) on the Milestone and Metrics objects to Subject Arm.
Configuring User & Entry Actions
Seed Subject Groups
Configure the Seed Subject Groups or Seed Subject Groups in Bulk user action 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
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 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 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 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 |