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.
Note: This feature is only available on Clinical Operations CTMS Vaults.
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:
- 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.
- Study Arm: Design object for Study Arms 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.
You must add the Visit Definition, Study Arm, and Subject Visit objects to the Study or Subject object page layouts.
The objects above include the EDC ID field to support the EDC to CTMS FTP Connection.
This feature also adds the Arm field on the Subject object to allow study managers to associate Subjects with Study Arms.