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.
Subject Groups
Study managers can use the Subject Group (arm__v) object to define and track standard sets of subject groups for a Study. Users can track various distinct subject groupings based on study needs by creating Subject Groups with different object types. Subject Groups can have the following object types:
- Study Arm: A set of participants with distinct interventions or no intervention.
- Study Cohort: A group of participants to be analyzed.
- Study Element: An open option to group participants based on your study needs.
- Study Part: A group of participants commonly used in sequential trial designs where the outcome of the first study part informs subsequent parts.
- Substudy: A group of participants used for a specific research hypothesis separate from the main study. Substudies are seen in many trial designs such as master protocols and include distinct objectives, a scientific rationale, and a detailed statistical analysis plan.
To create a Subject Group, navigate to the Subject Group section on the Study record, click Create, and select a Subject Group Type from the dropdown list.
Tracking Products, Countries, and Sites Utilized in a Subject Group
You can track the Study Products, Study Countries, and Study Sites utilized for a specific subject group within the Subject Group record. Vault creates related records for the current products, countries, and sites for the Study when you click Seed Subject Groups in the Subject Group All Actions menu. Once taken, Vault also automatically creates new records for new study products, countries, and sites when users add them to the Study object. The Subject Group join objects have standard lifecycle states that match the standard lifecycle states of the related object, such as the Study Product, Study Country, or Study Site object. You can configure lifecycle state transitions for the Subject Group join objects according to your business needs and processes.
Subject Group Metrics & Recruitment Planning
Vault allows you to track subject metrics and recruitment planning for subject groups in Enrollment Metrics records and Enrollment Metrics Over Time records on Subject Group objects. To allow Vault to calculate metrics and create Enrollment Metrics records for the Subject Group object, select Yes for Track Enrollment Metrics field on the Subject Group object. Select Yes for the Create Recruitment Plan field on the Subject Group object to allow Vault to calculate metrics over time and create Metrics Over Time records for the Subject Group object.
When the Metric Calculation field on the Study is set to Date-Based or Metrics Only, Vault creates matching Enrollment Metrics records and Enrollment Metrics Over Time records for both the Subject Group and Study when the Seed Metrics entry action is run. You can separately seed Metrics for a Subject Group added after the initial set of Metrics records have been created using the user action on the Subject Group record.
When calculating metrics, Vault performs the metric calculations for subject groups and studies independently. When a Subject is included in a Subject Group, Vault counts the subject for the subject group metrics calculations and study metrics calculations separately.
Note: Vault only supports Date-Based and Metrics Only metric calculations for Subject Group metrics.
Subject Group Milestones
You can track milestones for Subject Group objects by manually creating Subject Group specific milestones. Vault can populate Actual Finish Dates for Subject Group specific milestones by enabling the Automated Enrollment Milestone feature and setting the Metric Calculation field on the Study to Date-Based.
When the Automated Enrollment Milestone feature is enabled, Vault populates enrollment milestones for the Study and Subject Group independently and populates the Actual Finish Date for Subject Group milestones based on the dates entered for related Subjects within the Subject Group. For example, Vault looks for the earliest enrolled date for all Subjects with a specific Subject Group record when populating the Actual Finish Date on the corresponding subject group First Subject In milestone, but looks at all dates on all related Subjects for non-subject group milestones.
Vault also populates the Actual Finish Date on last subject-related milestonesfor Subject Groups when you select Yes for the No New Subjects field on the Study Site Subject Group record to indicate when enrollment is complete for the Subject Group. This allows you to specify when subject enrollment is complete for a Subject Group, even if subject enrollment is not complete for the Study Site. Clearing the No New Subjects field on the Study Site Subject Group removes the Actual Finish Date from the corresponding Subject Group last subject-related milestones.
Note: Veeva does not recommend updating Subject Group values for subjects who participate in multiple instances of the same Subject Group type. We recommend assigning separate subject identifiers for each instance to maintain the corresponding Milestone and Metrics values.
Subject Group Payments
Vault allows you to define Fees and Fee Templates for different Subject Group object types, allowing you to create flexible Fee Schedules with different visit activity amounts based on different populations.
Subject Group Fee Matching Criteria
Fees with no Subject Groups apply to all Subjects. However, Fees with a defined Subject Group only apply to Subjects within the listed Subject Group. When a Fee has multiple Subject Groups, Vault only creates payable items for Subjects that match the Fee criteria for all specified Subject Groups. For example, a Fee with Cohort Subject Group value of Cohort 1 and a Study Part of Part A will only apply to subjects with both the cohort and study part field populated for the subject.
When the Automated Adjustments for Payments setting is enabled, changes made to Subject Group values on relevant Subject record fields that affect the Fee matching criteria trigger the evaluation of related Payable Items. Vault inactivates the Payable Item and creates an Adjustment Payable Item to indicate what has been paid and/or what still needs to be paid.