1 Introduction

Dossier is a tool that works within the Argus Safety application and enables you to generate periodic reports.

Dossier Report Process

The complete Dossier report process has several steps:

• Configuring Dossier

• Creating and Reviewing Report Content

• Approving Content and Publishing Reports

Configuring Dossier

The task of configuring Dossier is performed by the administrator. It is the first step in the Dossier report process and is initiated as soon as the administrator determines there is a need for a specific report. Normally, this will be as soon as a product is approved for market. Dossier configuration includes the following:

• Configuring Periodic Data

• Configuring Periodic Report Templates

Configuring Periodic Data

The administrator configures the reports by entering the following:

• Report Name

• Product Name

• Inclusion Criteria

• Line Listings,

• Summary Tabulations

• User-defined Summaries

• Datasheet Information

• Report Scheduling Information

Configuring Periodic Report Templates

The administrator configures the report templates as follows:

• Writes the template scripts defining the report content

• Determines whether the report template contains one or more sections

• Uses authoring tools to verify the content of the template

• Assigns each section of the template to one or more groups for the authoring cycle

• Assigns the groups that are notified when Dossier authoring or reviewing is required.

• Assigns groups as the template owner (who can perform any action and can publish the report)

After the report templates are configured, the system does the following:

• Sends an e-mail message to the assigned authors and reviewers on the date the report is to be generated (scheduled date and time)

• Generates the periodic report and creates an entry on the Reports -> Period Reports section of the Argus application

• Places an entry on the Worklist -> Reports section of the Argus application for the assigned users (in any role)

• Notifies the administrator and users that the periodic report has been generated and is ready for review.

Creating and Reviewing Report Content

Once a report has been generated and the users notified of its existence, the assigned authors and reviewers perform their associated tasks. You can check out documents and edit them manually using the Microsoft Word application on your local desktop. Once the document has been edited, you can check the document in and mark it Ready for Build.

The task of the reviewers is to verify that the report content is correct and complete. Once a report is complete, the reviewer submits it for approval and final build.

Approving Content and Publishing Reports

Once all the sections of a report are marked as Ready for Review, you can generate a merged PDF for the final report. Once the PDF is created, users can view it.