OpenRIMS-PVM - User Manual Chapter 7

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1        Information Portal

The information portal is the centralized hub for publication and presentation. PVIMS information publishers have the ability to share trends, analysis, graphs, and important information about pharmacovigilance activities.

Note: the following roles have access to the information portal:

·         All users. All users have view access to pages defined within the portal.

·         Administrator. The administrator has FULL permissions to the information portal.

·         Publisher. The publisher has the ability to add new pages and update content of existing pages

1.1        Viewing the home page

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The Information Portal Home Page can be used to show information about upcoming pharmacovigilance activities as well as outcomes from existing and previous activities and reports.  To access the Home Page, click on the Home menu in the Information Portal.


The system will navigate you to the Home Page where you are able to view information such as national guidelines or other information you post that would be relevant to most PViMS users.



To view information for an existing date, click anywhere on the row expand or compress that guideline as required.



1.2        Viewing the Reference page

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The Information Portal Reference Page contains a set of reference data particular to the implementation of PViMS for Pharmacovigilance activities.  To access the Reference Page, click on the Reference menu in the Information Portal.

The system will navigate you to the Reference page where you are able to view this information.



The following reference data is available for viewing: -

MedDRA Medical Dictionary for Regulatory Activities
ICD10 International Classification of Diseases
HL7 Health-Level 7
E2B Electronic Transmission of Individual Case Safety Reports
Naranjo Naranjo Adverse Drug Reaction Probability Scale
WHO WHO Adverse Drug Reaction Probability Scale
CCTAE Common Terminology Criteria for Adverse Events
DAIDS Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events
ANRS ANRS scale to grade the severity of adverse events in adults



To view information about the reference, click on the header for that specific reference.



The system will navigate you to a reference pop up which contains additional information to that reference item.



1.3        Viewing the Frequently Asked Questions page

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The Information Portal FAQ Page contains a list of frequently asked questions particular to the implementation of PViMS for Pharmacovigilance activities in relation to the use of Bedaquiline.  To access the FAQ Page, click on the FAQ menu in the Information Portal.


The system will navigate you to the FAQ page where you are able to view these questions.




To view the answer for a specific question, click anywhere on the row to expand or compress the answer for that question.


1.4        Modifying Content in the Information Portal

The information Portal is based on a content management platform whereby PViMS publishers have the ability to add new and modify existing content within this portal in a collaborative manner. This provides PViMS analysts with an integrated platform to share details of their ongoing analysis to the health community at large.

1.4.1       Adding a New Page

BUZZWORDS

Page: Consists of 1 to 6 widgets, with each widget containing content that is rendered as part of the overall page. Each page is accessible either from the main information portal menu or from within an existing widget.

When adding a new page, you are creating a platform to add content that is specific to the overall theme of that page. To add a new page to the Information Portal, you need to have the Publisher Administrator role assigned to your user profile.


To add a new page, click on the List Pages menu.


Then click on the Add Page button to configure the core characteristics of the new page.


The following information must be entered when saving a new page:

Page name The unique name of the page. This is also the name of page header when viewing the page.
Definition Provide additional information that describes the page
Breadcrumb The name of the menu option that you can access to view the page
Visible to Menu Should this page appear on the main list of menu items in the Information Portal?


Enter the relevant information for the page and either click the Save button to save your new page or the Cancel button to cancel your action and return to the previous page of the portal.

The new page will appear in the main Information Portal menu if the visible to menu field is set to yes. See the next section for information about how to add content to a page using widgets.

1.4.2       Adding a Widget to a Page

BUZZWORDS

Widget: A widget is an individual panel within a page that provides a container for rendering dynamic content defined by the PViMS publisher. A page within the Information Portal can store up to 6 widgets per page.


When adding a new widget, you are adding a container for new content that is specific to the overall theme of that page. To add a new widget to a page, you need to have the Publisher Administrator role assigned to your user profile.


To add a new widget, navigate to the page that you would like to add the widget to by selecting the visibility icon for the appropriate report in the list reports menu.


Once the system has navigated you to the newly created page, click on the Add Widget icon that appears in the page header.



The following information must be entered when adding a new widget:

Widget name The unique name for the widget. This name will be displayed as the title for the content.
Widget type The type of widget to be added (General, ItemList, SubItems)
Widget Status The status of the widget (Published, Unpublished)

Please note: new widgets have to be added in an unpublished status

Icon The icon that should accompany the title of the widget



Enter the relevant information for the widget and either click the Save button to add your new widget or the Cancel button to cancel your action and return to the page.


The system will add the new widget to the page in the unpublished widgets section and will now allow the user the ability to add content to the widget. Please note that a unique ID has now been allocated to the widget.


Please see the section on adding content to a widget for further information on modifying content for the new widget.

Please note: the new widget is allocated to the page as an unpublished widget. This widget therefore cannot be viewed by users who do not have the Published Administrator role assigned to their user profile.

1.4.3       Adding or Changing a Widget’s Content

To add content to a new widget or edit content within an existing widget, you need to have the Publisher Administrator role assigned to your user profile.


To add or edit content within a widget, navigate to the page that you would like to modify the content, locate the widget you would like to modify and click the Update widget icon for this widget.



The system will navigate you to the Edit Widget pop up form where you will have the ability to edit your content.


1.4.3.1       General Widget Content

To change content for the general widget, locate the editor field in the General Content section for the widget and edit your content as necessary. Click the Save button to save your changes or the Cancel button to cancel this action and return to the page view.



1.4.3.2       ItemList Widget Content

To change content for the ItemList widget, locate the Item Content section for the widget. To add a new item to the item list, click the add icon.

Select the tab you would like to edit content for and then enter the title for the new item as well as the content associated to this item.

Click the Save icon to save the new content or the Delete icon to delete the tabbed item.

Once you are finished, click the Save button to save your changes or the Cancel button to cancel this action and return to the page view.

1.4.3.3       Wiki Widget Content

To change content for the Wiki widget, locate the Wiki Content section for the widget. To add a new item to the item list, click the Add icon.

Select the tab you would like to edit content for and then enter the title for the new item, as well as the sub-title and the page that the Wiki item should be routed to when clicked.


Click the Save icon to save the new content or the Delete icon to delete the tabbed item.

Once you are finished, click the Save button to save your changes or the Cancel button to cancel this action and return to the page view.

1.4.4       Publishing a Widget

BUZZWORDS

Publish: Widgets in an unpublished status are not viewable by standard users of the Information Portal (those who do not have the Publisher Administrator role assigned to their user profile). Conversely, widgets in a published status are viewable by all users who have access to this portal.


Widgets are only to be published once the publisher is happy with the content submitted.


To publish a widget, navigate to the page that you would like to modify, locate the widget you would like to publish and click the Update widget icon for this widget.


The system will navigate you to the Update Widget pop up form where you will have the ability to configure the widget.


Change the status of the widget to Published and confirm the location of the widget. Click the Save button to save your changes or the Cancel button to cancel this action and return to the page view.

The location determines where on the page the widget will appear. Only one widget can occur in each of the 6 allocated spaces on a page.


The system will navigate you to the page that you have published the widget on. Please note that the widgets will be removed from the Unpublished Widgets section and the widget will now be viewable on the page itself.


Saving a widget as unpublished will remove the widget from the page and move it to the Unpublished Widgets section. Widgets in this section are not viewable by standard users of the Information Portal.


1.4.5       Deleting a Widget

To delete a widget, navigate to the page that you would like to modify, locate the widget you would like to delete and click the Delete icon for this widget.


The system will navigate you to a Delete Widget pop up form where you will have the ability to delete the widget.


Click the Delete button to confirm the deletion or the Cancel button to cancel this action and return to the page view.

The widget and all related content will be deleted when clicking the Delete button.

1.4.6       Moving a Widget to a New Page

To move a widget, navigate to the page that you would like to modify, locate the widget you would like to move and click the Move icon for this widget.

You are only able to move a widget if it is currently in an Unpublished status on the page it resides on.


The system will navigate you to a Move Widget pop up form where you will have the ability to select the destination page for the widget.


Select the destination page and click the Save button to confirm the move or the Cancel button to cancel this action and return to the page view.


The widget and all related content will be moved to the new page and will exist in an Unpublished status on the new page.