Sections in This Article
- About Masked Aggregate Report Tabulations
- Configure Masked Aggregate Reports
- Supported Tables
- Masked and Unmasked Report Copies
About Masked Aggregate Report Tabulations
Vault Safety can generate both masked and unmasked aggregate tabulations, so that you can have the documents ready for both masked non-regulatory distributions and unmasked regulatory submissions. This feature is available for DSURs and PBRERs that contain a Study reporting family member, where the associated Study has the Blinded field set to Yes.
Configure Masked Aggregate Reports
Note Masked documents are not generated for DSUR appendices.
The system supports generating masked copies of the following tables for PBRER and DSUR:
- Interval Line Listings of Serious Adverse Reactions
- Cumulative Tabulation of Serious Adverse Events from Clinical Trials
Masked and Unmasked Report Copies
When an aggregate report is configured to enable Generate Masked Documents, the system generates both a masked and unmasked copy of the supported tables.
For the masked copy, the system prepends “Blinded” to the name of the report document.
The system protects the unmasked copy with Vault Safety blind protection. Only users with authorized access to unblinded information can access the unmasked copy.
If a double-blinded Case is unblinded before a study is complete, for example, a SUSAR Case, the Case data will be shown as unblinded in the unmasked report document. But the data will be still masked as
Blinded in the masked version of the report document.