Author Aggregate Reports

Learn how to use Vault SafetyDocs to manage a streamlined authoring process for Aggregate Reports.

About Aggregate Report Authoring

Vault SafetyDocs supports authoring all components of aggregate reports directly in your Vault, providing a secure and traceable way of managing the end-to-end authoring process.

When creating an Aggregate Report, you can track details such as report type, data period, and important dates. You can also add several Aggregate Report Destinations to keep track of details related to the submission of the report to regulatory organizations. Aggregate Reports can be split up into Sections to manage every part of the report separately and set up further actions such as automatically generating documents or tabulations.

Go through the information on this page to learn more about authoring aggregate reports in Vault SafetyDocs.

Prerequisites

Your Admin must configure your Vault to use the features described on this page. The following pages provide more information:

Working with Aggregate Report Documents

When uploading aggregate report documents to your Vault’s library, use the Aggregate Reports document type. This includes the following subtypes and classifications:

  • For a DSUR, select Aggregate Reports > Clinical > DSUR
  • For a PSUR, select Aggregate Reports > Postmarketing > PSUR
  • For a PBRER, select Aggregate Reports > Postmarketing > PBRER
  • For a PADER, select Aggregate Reports > Postmarketing > PADER
  • For a CIOMS II, select Aggregate Reports > Postmarketing > CIOMS II

Create an Aggregate Report

Complete the following steps to create an Aggregate Report record:

  1. From the Aggregate Reports tab, select the type of report that you want to create.
  2. On your selected report type’s page, select Create.
  3. Depending on your selected report type, complete the fields as described on the following pages:

The following fields also appear on the Create [Report Type] page:

Field Description
Aggregate Report Template Select a template from the dropdown or select the Advanced Search icon to use filters and refine your search.

Aggregate Report Templates automate the creation of Aggregate Report Sections to enhance the efficiency and traceability of your authoring process. For more information, see Automatically Generate Sections.

To add new templates to your Vault, refer your Admin to Configure Templates for Aggregate Report Authoring.
Earliest Submission Date Vault populates this field with the earliest Planned Submission Date entered on the Aggregate Report Destinations added under this report.

Save the page to finish creating the record.

Create an Aggregate Report Destination

Aggregate Report Destinations are records of each market and health authority to which you submit aggregate reports.

Complete the following steps to create an Aggregate Report Destination:

  1. Go to the Aggregate Report Destination section of your Aggregate Report record and select Create.
  2. In the Create Aggregate Report Destination dialog, select from the following types:
    • Health Authority Submission
    • Partner Distribution
  3. Select Continue.

The following fields appear:

Field Description
Aggregate Report Vault populates this field based on the report for which you are creating the Aggregate Report Destination.
Aggregate Report Destination Type Vault populates this field based on the option you selected in the Create Aggregate Report Destination dialog.
Applicable Market The market that applies to the Aggregate Report Destination.
Select the market from the dropdown or select the Advanced Search icon to use filters and refine your search.
This field appears only on Health Authority Submission type Destinations.
Destination Organization The organization to which the report is being sent.
Select the organization from the dropdown or select the Advanced Search icon to use filters and refine your search.
Planned Submission Date Enter the date the report should be submitted.
Use the calendar to select the date or enter the date manually.
Actual Submission Date When available, enter the date the report is submitted.
Use the calendar to select the date or enter the date manually.
Health Authority Decision Date When available, enter the date the relevant health authority makes a decision about the report.
Use the calendar to select the date or enter the date manually.
This field appears only on Health Authority Submission type Destinations.
Health Authority Received Date When available, enter the date the relevant health authority receives the report.
Use the calendar to select the date or enter the date manually.
This field appears only on Health Authority Submission type Destinations.
Masked If you want to include masked versions of generated line listings and tabulations in the final ZIP file of this report, select Mask Unblinded Content from the dropdown.
This field appears only on Partner Distribution type Destinations.
PV Agreement Select the PV Agreement that outlines the clause for sending this report to a partner.
This field appears only on Partner Distribution type Destinations.
PVA Activity Select the PVA Activity fulfilled by sending this report to a partner.
This field appears only on Partner Distribution type Destinations.

Save the page to finish creating the record.

Generate Aggregate Report Sections

To track the authoring process, you can divide each Aggregate Report into Aggregate Report Sections as follows:

  • Global Sections track requirements that apply to all Aggregate Report Destinations added to an Aggregate Report record.
  • Local Sections track requirements that are specific to certain Aggregate Report Destinations. For example, if a health authority requires a new appendix for every line listing, add this appendix as a local Section of the report.

For every Section, you can record such details as the description, important dates, and the person responsible for completing it. With the scope and ownership of each Section clearly defined, you can track the drafting status individually to support a smooth authoring process.

There are two (2) ways to create Aggregate Report Sections:

  • Automatic generation
  • Manual creation

Automatically Generate Sections

You can automatically generate Aggregate Report Sections by using an Aggregate Report Template. Every system-provided template contains multiple Aggregate Report Template Items, each mapped to a separate area of the report that requires authoring.

When Aggregate Report Sections are generated from this template, a Section record is created for each Template Item.

Complete the following steps to automatically generate Sections:

  1. Go to the Aggregate Report record for which you want to generate Sections.
  2. From the All Actions menu, select Generate Aggregate Report Sections. The Aggregate Report Section Generation dialog appears.
  3. If you want to generate local Sections, select the Local Sections checkbox in the dialog. Otherwise, proceed to step 4.
  4. Select Confirm.

The generated Aggregate Report Sections appear on the Aggregate Report record.

If you select the Local Sections checkbox, local Sections are also generated. You can identify them by the populated Aggregate Report Destination field.

Manually Create Sections

If your Aggregate Report record is not associated with a template, or if you want to add Sections, you can manually create Aggregate Report Section records to track relevant information by completing the following steps:

  1. On your Aggregate Report record, go to Aggregate Report Sections and select Create.
  2. In the Create Aggregate Report Section dialog, select from the following options:

For both automatic and manual creation, the following fields appear:

Field Description
Name Enter a name for the Section.
Aggregate Report Vault populates this field based on the report for which the Section has been created.
Aggregate Report Type Vault populates this field based on the information entered when creating the report.
Aggregate Report Section Type Vault populates this field with the option you selected in the Create Aggregate Report Section dialog.
Aggregate Report Destination This field determines whether a Section is global or local.
If you are manually creating a local Section, select the related Destination from the dropdown or select the Advanced Search icon to use filters and refine your search.
Description Enter a description detailing the requirements of the Section.
This field supports up to 500 characters.
Assigned To The user responsible for completing the Section. This user will be granted access to edit this Section record as well as the documents linked in the following fields: If the user is removed from this field, their access will be revoked.
Select a user from the dropdown or select the Advanced Search icon to use filters and refine your search.
Due Date Enter the date the Section should be completed.
Use the calendar to select the date or enter the date manually.
Complete Select Yes or No to indicate whether the Section has been completed.
Completion Date Enter the date the Section is completed.
Use the calendar to select the date or enter the date manually.
Report Document The document that is or will be authored to complete this Section.

If this Section was auto-created from a template and the corresponding Template Item has a document template, Vault creates a document from the template and links it to this field. You can use the document to draft this Section of the report.

If this Section was created manually, select a document from the dropdown or select the Advanced Search icon to use filters and refine your search.

For Safety Tabulation type Sections, Vault links generated tabulation reports to this field.

For Vault Report type Sections, Vault links report-generated documents to this field.
Aggregate Report Template If this Section was auto-created from a template, Vault populates this field with the associated template.
Aggregate Report Template Item If this Section was auto-created from a template, Vault populates this field with the corresponding Template Item.
Section Order If this Section was auto-created from a template, Vault assigns it a number to order Sections in the final Aggregate Report ZIP.

If this Section was created manually, assign a number to set its order. We recommend numbering the Sections by 10s, for example, assigning 10 to the first Section, 20 to the second, and so on.

Save the page to finish creating the record.

Generate Final Aggregate Report ZIP

You can generate a ZIP file of your authored Aggregate Report directly from each Aggregate Report Destination record, allowing easy distribution to partners and submission to health authorities.

To generate the ZIP file, go to the Aggregate Report Destination record from which you want to generate the file. From the All Actions menu, select Generate Final Aggregate Report ZIP.

Result

Vault generates a ZIP file organized in the order of the created Aggregate Report Sections as set in the Section Order field. The file appears in the Attachments section of the selected Aggregate Report Destination record, available for download as needed.

Considerations for Generating ZIP Files

When generating an Aggregate Report ZIP file, keep the following things in mind:

  • The ZIP file includes all global Sections and local Sections specific to the selected Aggregate Report Destination.
  • If you set the Masked field on the Aggregate Report Destination record to Mask Unblinded Content, the generated ZIP file includes masked line listings and tabulations linked in the Report Document (Masked) field on related Safety Tabulation type Sections. For more information, see Generate Tabulations Using Aggregate Report Sections.
  • Vault generates a new ZIP file each time you initiate the action unless all included documents are unchanged since the last generation.
  • If an Aggregate Report Destination record includes 50 or more attachments, you must manually delete some attachments and re-run the action to generate a new ZIP file.

Aggregate Report Section Assignment Workflow

You can use an Aggregate Report Section Assignment workflow to keep track of all the steps involved in authoring a Section of an Aggregate Report. This is a default workflow available for configuration in your Vault. Your Admin may configure your Vault with alternate steps based on your organization’s processes.