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. Additionally, Responsibilities can be assigned to Study Persons directly from Study Person object records.
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. Additionally, users can restrict the assignment of Study Team Roles based on Person Type and/or Security Profile. When you attempt to save a record, Vault performs validation checks to prevent users from creating Study Person records with disallowed combinations.
Note: For security reasons, the maximum number of Study Team Roles allowed in a Vault is 300. If you attempt to create an additional Study Team Role and there are already 300 records in your Vault, Vault issues an error message and does not allow you to continue.
Example
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.
As an additional layer of security, Vault does not allow any changes to the Study Person, Study Team Role, Study, Study Country, and Site records while the Grant Access to Related Records (create_urs__v) field is set to Yes.
How to Create Study Persons
- Navigate to the Study Personnel tab.
- Click Create.
- Select a Person.
- Select a Study Team Role.
- Select a Study and then a Study Country and Study Site, if needed.
- Set the Grant Access to Related Records field to Yes.
- Select the Survey Sender Type from the picklist. For surveys of the type you select here, Vault uses the Study Person’s email address when sending the survey if the Study Person is associated with the survey.
- 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.
Note: If the Study Person object contains required custom fields, Vault will still create the Study Person record but will not populate the fields.
Study Person Responsibilities
Vault supports assigning one (1) or more Responsibilities to a Study Person, such as Principal Investigator, along with the duration the person is performing that task. These are defined as Study Person Responsibility object records and can be added to Study Person records using their Study Person Responsibilities section.
You must assign Study Personnel to a Study Site before you can add Responsibilities.
To add a Responsibility to a Study Person:
- Navigate to the Study Person record.
- Under Study Person Responsibilities click Create.
- Select a Responsibility from the Responsibilities picklist.
- Optional: Select additional Responsibilities as needed.
- Optional: Assign a Start Date and an End Date. These will apply to all Responsibilities selected above.
- Click Submit.
Once at least one is assigned, Vault lists all Responsibilities assigned to the Study Person in this section.
To edit a Responsibility:
- Navigate to the Study Person record.
- Under Study Person Responsibilities, click the All Actions menu for the Responsibility you wish to modify.
- Click Edit to change the assigned Responsibility, its Start Date, or End Date. Click Delete to remove the Responsibility.
Customers with connected Study Training Vaults can transfer Study Person Responsibility records to Study Training to define Responsibility-based training.