Prepare Aggregate Report Documents

Create and author aggregate reports using Vault Safety templates and document collaboration tools.

Sections in This Article

Create the Report Document

Create the report document from an aggregate report template.

  1. Go to the Library.
  2. Select Create > Document from Template.
    The Create Document from Template (Step 1) page appears.
  3. Under Choose document type, select one of the following types:
    • 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.
  4. Under Choose template, select the template to build the report from.
  5. Select Next.
    The Create Document from Template (Step 2) page appears.
  6. In the Name field, enter a name for the document.
  7. In the Organization field, select the appropriate organization.
  8. In the Aggregate Report field, select the aggregate report.
  9. Select Save.

Result

The system starts generating the report document. Vault sends a notification when the document generation is complete.

Author the Report

Once the system generates the aggregate report document, you can author the report using vault’s collaborative authoring capabilities. Edit a Document provides more information.

To learn more about versioning documents, management, or collaborative authoring, visit Vault Help.

Tip Your administrator can set up custom aggregate report document templates for your organization. Configure Aggregate Report Templates provides more information.

Upload a Document to an Aggregate Report

You can upload additional documents as you prepare an aggregate report.

  1. From the Aggregate Reports tab, go to the Aggregate Report record to which you want to add documents.
  2. Expand Documents, and then select Add.
  3. If the document exists in your vault already, select it and close the window.
  4. To upload a document from your computer, perform the following steps:
    1. On the Upload Files (Step 1) page, drag and drop the file into the blue area or select Choose to browse for the file on your computer.
    2. From the Choose document type list, start typing Aggregate Reports, and then select one of the following 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.
    3. Select Next.
    4. Complete the Upload Files (Step 2) page, and ensure to set the Organization field to the same organization specified on the aggregate report.

      The system automatically populates the Aggregate Report field with the name of the Aggregate Report record.

    5. Select Save.

Download Aggregate Report Documents

To download a document, open the document, and then select an option from the Download Options menu. The icon for this menu depends on the document type.

The following image highlights the Download Options menu:

Download Options Menu
Download Options Menu

Combine Documents to Binder and Merge

You can combine all documents for an aggregate report into a single binder and then merge that binder to a PDF.

Create Aggregate Report Binder

  1. From the Aggregate Reports tab, go to the Aggregate Report record to which you want to add documents.
  2. Expand Documents, and then select Show in Tab.
    The Library tab appears, filtered to show only the documents within the aggregate report.
  3. From the All Actions (All Actions) menu, under Perform Bulk Action, select All x Documents.
  4. On the Refine Selection (Step 1) page, ensure that the documents you want to add to a binder are selected, and then select Next.
  5. On the Choose Action (Step 2) page, under Manage Documents, select Add to Binder, and then select Next.
  6. On the Add to Binder (Step 3), from the Choose document type list, start typing Aggregate Reports, and then select one of the following 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.
  7. Select Next.
  8. Complete the Create Binder (Step 4) page, and ensure to select the Organization and Aggregate Report that match the source Aggregate Report record.
  9. Select Next.
  10. On the Confirmation (Step 5) page, check that the binder details are correct, and then select Finish.

Merge Aggregate Report Documents

Merge a Binder to PDF provides instructions to merge the PDF once you have created the binder.

Assign User Tasks to Prepare the Report

  1. Go to the Aggregate Report record.
  2. Expand Documents.
  3. Beside the search bar, select Show in Tab.
    The Library tab appears, filtered to the documents in the aggregate report.
  4. Expand the Workflow State Change Menu (Workflow-State-Button) on the Action Bar, and then select Start Multi-document Workflow.
  5. Complete the following fields in the Start Multi-document Workflow window:
    • Multi-document Workflow: Select Aggregate Report Workflow, and then select Continue.
    • Description: (Optional) Edit the workflow description.
    • Primary Author: Select the user responsible for writing the report.
    • Collaborators: Select one or more users who will collaborate on the report.
    • Approvers: Select one or more users who must review and approve the report.
  6. Select Start.

Result

The system starts the workflow and assigns a task to the Primary Author to prepare the report.

Complete Aggregate Workflow Tasks

Note The following sections describe tasks in the default aggregate report workflow configuration. If your organization has a custom workflow, follow the recommendations in your business standard operating procedure for approving cases.

Mark the Author Report Task as Complete

  1. From Home > My Tasks, accept the Author Aggregate Report task.
  2. Beside the Author Aggregate Report task, select Continue.
    The aggregate report document envelope appears.
  3. In the Review & Author Report task banner, select complete-button.
    The Review & Author Report window appears.
  4. Select complete-button.

Result

The system assigns a Review and Approve Documents task to appropriate workflow participant.

Review and Approve Report Documents

  1. From Home > My Tasks, accept the Author Aggregate Report task.
  2. Beside the Author Aggregate Report task, select Continue.
    The aggregate report document envelope appears.
  3. After reviewing the documents, select a verdict for each:
    Document Verdict
    Select a Verdict for Each Document
  4. In the Review and Approve Documents task banner, select complete-button.
    The Review and Approve Documents window appears.
  5. Select complete-button.

Result

Each approved document moves into the Approved lifecycle state, and the task is complete.

Mark the Aggregate Report as Complete

Once the report is complete and approved, mark the aggregate report as complete.

  1. Accept the Review & Author Report task.
  2. Beside the Review & Author Report task, select complete-button.
    The Review & Author Report window appears.
  3. Under Verdict, select Report Authorship Complete.
  4. Select complete-button.

Result

The Aggregate Report record enters the Submission stage.


Generated Masked Aggregate Tabulations (PBRER and DSUR)
Coordinate Aggregate Report Submission
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