With the 20R1 release, Veeva Safety introduces masked distributions for study and patient content protection. This feature allows Admins and Distribution Managers to generate Distributions and ICSRs that selectively mask sensitive patient or blinded study data, while continuing to generate unmasked Submissions for regulatory agencies. This feature works with the Transmission and Reporting Family objects.
Once you enable this feature, configurable field masking allows you to mask or unmask certain fields in masked distributions.
The following pages also describe how to use masked distributions:
- Generate Masked Safety Reports provides information about how masked distributions work and which fields are masked.
- Set Up Partner Distribution Lists provides information for administrators on how to set up reporting rules that automatically generate masked distributions.
- Create a Distribution provides information for Distribution Manager users on how to manually create masked distributions.
25R3 Update: Patient Content Protection: Mask PII (EU Guidance)
With the 25R3 release, Vault updates Personally Identifiable Information (PII) masking to meet the requirements of the EU GVP Module VI Addendum. This feature adds the Mask PII (EU Guidance) option to the Patient Content Protection field on Submissions which impacts masking on E2B files. On your custom reporting rule sets, you can configure new options on the Mask PII reporting rule parameter to define how Vault masks PII.
Update the Reporting Family Object
Navigate to Admin > Configuration > Objects > Reporting Family, and then make the following updates on the Layouts tab:
| Layout | Section | Fields to Add |
|---|---|---|
| Partner Distribution Detail Page Layout | Details |
|
Update the Transmission Object
Navigate to Admin > Configuration > Objects > Transmission, and then make the following updates on the Layouts tab:
| Layout | Section | Fields to Add |
|---|---|---|
| Distribution Detail Page Layout | Details |
|
| Inbound Transmission Detail Page Layout | Details |
|
Move Content Protection on Field Layout
Navigate to Admin > Configuration > Field Layout, and then move Content Protection between Sharing Settings and Workflow History.
Upload a Blinded Narrative Template
- Go to Business Admin > Documents & Binders.
- Expand Template > Narrative, and then select Default.
- In the Default pane, select Create > Document Template.
- On the Create Document Template page, enter the following details:
- Type: Select Basic Document Template.
- Label: Enter
Narrative Template Blinded.
- Beside Template Document, select Choose, and then upload the document that you want to use as the blinded narrative template.
- Select Save.
Result
Vault will use this template to generate narrative documents on blinded Study Cases.
(25R3) Configure Patient Content Protection: Mask PII (EU Guidance)
To mask Personally Identifiable Information (PII) on E2B files according to the latest EU guidance, navigate to Business Admin > Objects > Safety Rule Sets and, on any applicable reporting rule sets, create or update the Mask PII rule set parameter with one of the following Values:
- All (EU Guidance): Applies the EU masking rules to all Submissions.
- Foreign (EU Guidance): Applies the EU masking rules to Submissions for which the AE in Jurisdiction rule set parameter does not pass.