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. Vault 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 applicable Subject Group (
study_arm__v) object types: Study Cohort (study_cohort__v), Study Element (study_element__v), Study Part (study_part__v), and Substudy (study_substudy__v). - Configure Subject Group fields on the Subject (
subject__clin) object. - Define page layouts for Study Country Subject Group (
study_country_subject_group__v), Study Site Subject Group (study_site_subject_group__v), and Study Product Subject Group (study_product_subject_group__v) objects. - Configure Subject Group-related lifecycles.
- Update page layouts for Study (
study__v), Study Country (study_country__v), Study Site (site__v), Subject Group (study_arm__v), and Subject (subject__clin) objects. - Configure user actions on the appropriate Subject Group lifecycle states to enable users to create join records for Study Country, Study Site, and Study Product objects.
- Update permission sets and optionally Dynamic Access Control (DAC) to grant users access to the Subject Group objects and user actions.
- For CTMS users, configure user actions on the appropriate Subject Group lifecycle states to enable users to create Metrics and Metrics Over Time records.
- For Vault Payments users, configure Subject Group fields on Fee Template (
fee_template__v) and Fee (fee__v) objects for use in Vault Payments. - 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 object to Subject Group.
Configuring Subject Group Related Lifecycles
Vault includes object lifecycles for the Subject Group, Study Country Subject Group, Study Site Subject Group, and Study Product Subject Group objects. These lifecycles do not have existing configurations or associated workflows. To use the Subject Group-related lifecycles, an Admin must configure the lifecycle, workflow, and user actions for your company’s specific business needs.
Study Country Subject Group, Study Site Subject Group, and Study Product Subject Group lifecycles should be configured to use the Subject Group tracking capabilities.
Configuring User 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.
Related Permissions
You can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner profile.
If your Vault uses custom security profiles, your profile must grant the following permissions:
| Permission Type | Permission | Effect |
|---|---|---|
| Security Profile | Admin: Objects: Create, Edit | Ability to edit object details and page layouts. |
| Security Profile | Admin: Object Lifecycles: Edit | Ability to configure object lifecycles. |
| Security Profile | Admin: Object Workflows: Edit | Ability to configure object workflows. |
| Security Profile | Admin: Permission Sets: Read, Create, Edit, Delete | Ability to configure Permission Sets. |