In Clinical Operations Vaults, the Study Person object automates the creation of User Role Setup records according to rules specific to your Vault. Study Person records are leveraged across the Clinical Operations product suite and are used to manage document reuse across studies and access to archived studies.

Admins can set up a system where Study or Country Managers easily maintain their own team rosters, supporting a quicker study start up process and easier upkeep.

Study Persons & Dynamic Access Control for Documents

The Study Person object allows you to utilize the automation capabilities of your Clinical Operations Vault and the flexibility of Dynamic Access Control (DAC) for documents to avoid manually creating hundreds or thousands of User Role Setup records.

Admins can configure Study Team Roles that map to application roles and role dependencies to Study Team Role records.


Tracy is a Site CRA for Site 101. For this role, she needs Editor access to all Site 101 documents, but also needs Viewer access to country-level and study-level documents. Without Study Person, an Admin would manually set up three (3) User Role Setup records for Tracy. With this feature configured, the Study Manager could create a single Study Person record with the Grant Access to Related Records (create_urs__v) field set to Yes indicating that Tracy is a Site CRA responsible for Site 101. Based on the configuration, Vault would automatically create all three User Role Setup records.

When Tracy moves to a new position midway through the study, the process for removing her access is also simple. The Study Manager simply updates the Grant Access to Related Records field to No and then deletes or inactivates the Study Person record.

How to Create Study Persons

  1. Navigate to the Study Personnel tab
  2. Click Create
  3. Select a Person
  4. Select a Study Team Role
  5. Select a Study and then a Study Country and Study Site, if needed
  6. Set the Grant Access to Related Records field to Yes
  7. Click Save

If you select Principal Investigator for the Study Team Role field and also select a Study Site, Vault automatically adds that person to the Principal Investigator field in the Details section of the Study Site record. If the Study Site record already has a Principal Investigator and your administrator has enabled Sync PI Field with Study Person, the new person replaces the existing person in the Principal Investigator field. If Sync PI Field with Study Person is not enabled, Vault only updates the Principle Investigator field if it is blank. This does not occur if the site is in an Archived lifecycle state.

Vault automatically creates the User Role Setup records. Depending on the activity in your Vault, it may take a while before the user has access.

If Sync PI Field with Study Person is enabled and you add a Person to a Study Site’s Principal Investigator field, Vault automatically creates a new Study Person record for that Person with a role of Principal Investigator if one does not already exist.