Learn how to generate and manage tabulations at the Aggregate Report Section level.
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 Generating Tabulations for Aggregate Report Authoring
You can generate tabulations for your aggregate reports in Vault Safety. Generate Aggregate Report Tabulations provides more information for generating and managing tabulations at the Aggregate Report level. At this level, the tables are added to the Documents section on each record.
When authoring aggregate reports using Aggregate Report Sections, you can generate and manage tabulations individually at the Section level. This option gives you more granular control over the authoring process because tabulations can be generated or updated for specific areas of the report as needed.
Managing tabulations at the Aggregate Report level or managing them at the Aggregate Report Section level is determined by an Admin setting in your Vault.
The following sections provide more details.
Prerequisites
Consider the following prerequisites for generating tabulations and managing them at the Aggregate Report Section level:
- Your Vault must be licensed for Vault Safety to generate tabulations. Contact your Veeva representative for more information.
- Your Admin must enable Generating Tabulations Using Aggregate Report Sections.
- Your Admin must enable the Generate Tabulations Using Sections setting. If this setting is not enabled, you can still generate tabulations at the Aggregate Report level.
Generate Tabulations Using Sections
The following sections describe how to generate tabulations using Aggregate Report Sections:
Select a Document to Generate
To tell Vault which tabulation documents to generate, create Aggregate Report Sections and complete the Document to Generate field using the following steps:
- Go to an Aggregate Report record.
- Create Aggregate Report Sections.
- If you are automatically generating Sections using a template and your Admin has set up the corresponding Template Item, Vault automatically creates a Safety Tabulation type Section with the Document to Generate field populated.
- If you are manually creating Sections, in the Create Aggregate Report Section dialog, select Safety Tabulation.
- In the Details section, complete the Document to Generate field as follows and select Save:
Field | Value |
---|---|
Document to Generate | Select which tabulation document to generate from the dropdown.
The options that appear in the dropdown depend on the Aggregate Report Type. If this Section was auto-created from a template, Vault maps this field from the corresponding Template Item. |
The following fields also appear on Safety Tabulation type Sections:
Field | Value |
---|---|
Report Document (Masked) | When you select the Generate Masked Documents option on the parent Aggregate Report record, Vault links masked tabulation reports to this field. |
Report Document (Log) | Vault creates a log file and links it to this field every time tabulations are generated. |
Tabulation Generation Date | Vault populates this field with the date when tabulations are generated. |
Run the Generate Aggregate Report Tabulation Action
Once the Document to Generate field has been populated, generate tabulations for a specific Aggregate Report Section by going to the All Actions menu of that section and selecting Generate Aggregate Report Tabulation.
Note: The Generate Aggregate Report Tabulation action appears only for Safety Tabulation type sections.
When you initiate the action, Vault does the following:
- Generates tabulations based on the option selected in the Document to Generate field.
- Links the generated tabulations to the Report Document or Report Document (Masked) field on the Aggregate Report Section.
- Creates a log file in the library and links it to the Report Document (Log) field on the Aggregate Report Section.
- Populates the Tabulation Generation Date field on the Aggregate Report Section.
- Populates the Listing of Cases on Interval Report section with links to Cases from the following interval reports for the applicable aggregate report:
- DSUR: Interval Line Listings of Serious Adverse Reactions for Study Cases
- PBRER: Interval Line Listings of Serious Adverse Reactions (from Clinical Trials) for Study Cases
- PADER: Interval Line Listings
- PSUR: CIOMS II Interval Line Listing of Adverse Drug Reactions
- CIOMS II: CIOMS II Interval Line Listing of Adverse Drug Reactions
- PMDA Post-Market:
To generate tabulations for multiple sections at once, navigate to the parent Aggregate Report record, and from the All Actions menu, select Generate Aggregate Report Tabulations. When the action is run from the parent Aggregate Report record, Vault completes the actions above for all Safety Tabulation type sections on that record.
Update Generated Tabulations
To update these tabulation documents, you can run the Generate Aggregate Report Tabulations action again if your Aggregate Report Sections have not reached the Complete state. When the action is re-initiated, Vault regenerates the associated tabulations and upversions the linked documents with the new details. Related fields are also updated as required.