Oracle® Argus Affiliate User's Guide Release 8.1 E71875-01 |
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PDF · Mobi · ePub |
The Argus Affiliate Module enables users from a company's local affiliates to manage and track cases that are specific to their workflow. It is the complete and seamless solution that allows for case data from affiliates to be entered at the source, a complete case review, acceptance of the case into the central database, and determination if a case is reportable at the local level.
The following table lists some of the main tasks that users perform when using Argus Affiliate.
Task | Description |
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Log on to Affiliate | Log on to the Local Affiliate Module using a Local Affiliate account. |
Enter Local Event Information | Enter information about local events. |
Route Events to Central | Send the events to Central Safety for review. |
Log on to Argus Safety Web | Log on to Argus Safety Web as a regular Argus Safety user. |
Review and Accept Local Events | View events sent by local affiliates around the world and accept these events. |
Encode Events | Encode the events sent in by Local Affiliates. |
Perform Local Labeling | Label events for cases that are pending labeling. |
Submit Reports | Submit reports according to the requirements of local regulatory authorities. |
The following two broad categories of Argus Affiliate users can exist:
Central Users - These are users that belong to the Central Safety site of a pharmaceutical company.
Affiliate Users - These are users that belong to other global sites of the company or its local affiliates. Affiliate sites may fall under different regulatory reporting requirements compared to the Central Safety site and other affiliate sites.
Refer to the following sections for information about required fields and standard buttons used in Argus Affiliate.
Fields that are marked with a red flag image and have an orange boundary are required fields. These fields must be filled in to proceed with the configuration requirements.
The standard buttons used in Argus are described in the table below:
Button | Purpose |
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Save | Use this button to save changes associated with an event. |
Cancel | Use this button to cancel changes associated with a section. |
Use this button to print information associated with an event, in PDF format. | |
Add | Use this button to add an item associated with a section. |
Delete | Use this button to delete an item associated with a section. |
Copy | Use this button to create a new editable copy of an item within a section. |
OK | Use this button to confirm an action associated with a section. |
Yes | Use this button to confirm an action associated with a section. |
No | Use this button to cancel an action associated with a section. |
Help | Use this button to launch the online manual. |