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

Before starting to author an aggregate report, your Admin must enable Aggregate Report Management.

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 The system populates this field with the earliest Planned Submission Date entered on the Aggregate Report Destinations added under this report.

Create an Aggregate Report Destination

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

To create a Destination, go to the Aggregate Report Destination section of your Aggregate Report record and select Create. The following fields appear:

Field Description
Name The system populates this field based on the information entered when creating the report.
Aggregate Report The system populates this field based on the report for which you are creating the Aggregate Report Destination.
Aggregate Report Type The system populates this field based on the information entered when creating the report.
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.
Health Authority The health authority under whose jurisdiction the Aggregate Report Destination comes. Select the health authority 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 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.
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.

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 The system populates this field based on the report for which the Section has been created.
Aggregate Report Type The system populates this field based on the information entered when creating the report.
Aggregate Report Section Type The system 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 who is 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, the system 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, the system links generated tabulation reports to this field.

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

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.

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.