Learn how to set up CIOMS II, PBRER or DSUR aggregate reports to generate masked tabulations.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
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 the CIOMS II standalone report, DSURs and PBRERs that contain a Study reporting family member, where the associated Study has the Blinded field set to Yes.
Note: Masked documents are not available for the CIOMS II table that is part of the PSUR.
Configure Masked Aggregate Reports
Use the Generate Masked Documents option on the Aggregate Report (CIOMS II, DSUR or PBRER) record to generate a masked copy of report tables.
Supported Tables
The system supports generating masked copies of the Interval Line Listings of Adverse Drug Reactions table for the CIOMS II standalone report.
The system supports generating masked copies of the following tables for DSUR:
- Interval Line Listings of Serious Adverse Reactions
- Cumulative Tabulation of Serious Adverse Events from Clinical Trials
- Appendix: Cumulative Summary Tabulation of Serious Adverse Reactions From Clinical Trials
- Appendix: List of Subjects Who Died During the Reporting Period
The system supports generating masked copies of the following tables for PBRER:
- 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.
Note: The DSUR and the PBRER blind the data for any open arm studies on a Case if the study is still blinded.