With Subject Visits in Vault CTMS, study managers can define visits for a Study, allowing users to create and track visits and related source data verification (SDV) activities for a given Subject. This data is useful in monitoring reports and other study management reports.
Components Supporting Subject Visits
Vault includes objects that represent the definition of different visits for a Study, as well as objects and fields that support actual instances of visits related to a given Subject:
Objects
- Visit Definition: Design object for Subject Visits at the Study level. Subject Visits occur over the course of a clinical trial, and can include screen visits, visits for each month, end of trial visits, and more.
- Subject Groups: Design object for Subject Groups available for a Study. Admins can associate a Subject to a Study Arm defined for the Study.
- Subject Visit: Object storing Subject Visits a Subject has completed over the course of the clinical trial.
Admins must add the objects above to the Study or Subject object page layouts.
Fields
The objects above include the EDC ID field to support the CDMS and Clinical Operations Vault Connection.
This feature also adds the Arm field on the Subject object to allow study managers to associate Subjects with Subject Groups.
Defining Visits
Study managers can use the Visit Definition object to define a standard set of Subject Visits that subjects can attend during the course of a Study, for example, screening visits, baseline visits, per-week visits, or end of trial visits.
To create Visit Definition records, navigate to the Visit Definitions section on the Study record and click Create.
Defining Subject Groups
Study managers can use the Subject Group object to define a standard set of subject groups for a Study. For example, a Study could have an Experimental arm, in which Subjects receive treatment, and a No Intervention arm, where Subjects receive a placebo.
To create Subject Group, navigate to the Subject Group section on the Study record and click Create.
Creating Visits
After creating Visit Definition records for a Study, Study managers can create Subject Visits records for a given Subject. Subject Visit records track the visits that Subjects complete over the course of the trial.
To create Subject Visits, navigate to the Visits section on the Subject record and click Create.
Relating Subject Group to Subjects
After creating Subject Group records, study managers can navigate to the Subject record and select a defined Subject Group to associate the Subject to one of the Subject Group defined for that Study.
Related Permissions
The following permissions control the ability to define and create Subject Visits and Subject Group related to a Study:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Object: Visit Definition: Create | Ability to define Visit Definitions for a Study. |
| Security Profile | Object: Subject Group: Create | Ability to define Subject Groups for a Study. You must have Create on all object types for the Subject Group object. |
| Security Profile | Object: Subject Visit: Create | Ability to create Subject Visits that a Subject completes. |
| Security Profile | Object: Subject: Edit | Ability to edit a Subject record to associate a Subject to a Subject Group. |