Getting Started

After installing ARISg, you log onto the application, change your password and set specific options to begin with data entry.

Logging into ARISg

NOTE: The ARISg application supports the French, the Japanese and the Chinese languages.

REMEMBER: If you face problems during login, click the Troubleshooting link on the Login page and follow the instructions.

The ARISg and Admin applications allows you to re-log on to the application using the same login credentials while the first login is still active, by selecting the "continue with the new login session" option. You may also exit the re-login session by selecting "cancel".

Note: The User Name, Password, and Database fields are case sensitive in Oracle 11g.

In this section you identify the elements on the main page of ARISg application.

You also understand the various toolbar buttons that appear differently depending on your permissions.

Toolbar Icons	Description
	Opens the AER Registration page for entering information on the adverse event.
	Helps you to retrieve a case using the basic and advance search mechanisms in QBE. The application allows you to access the QBE and Advanced QBE depending on the privileges.
	Stores the information you enter in a case.
	Closes the case that you have currently opened.
	Runtime Reports creates scheduled reports such as Online, Final, Draft or Other, for the active adverse events report (AER).
First Previous Next Last	Buttons that you use for seeing the different pages or records of the case.
	Global Homepage displays when you have not configured the Personal Homepage. The application provides a common Global Homepage to all the users. Any modifications to the Global Homepage or Group Homepage results in the creation of a Personal or User Homepage.
	The Group Homepage gets created when ARISg Administrator creates or modifies a Homepage and assigns this Homepage to various roles. The Group Homepage displays the various homepages associated to the role of the user logging in.
	The Notes icon appears on the toolbar, only when you open the case from the (a) List of selected AERs (b)Recent AERs and (c) Workflow case list. After opening the case, click the Notes icon and view the notes associated to an activity from the initial to the current stage; however the application does not allow you to modify the notes.

Interpreting the Tool bar Icons

Toolbar Icons	Description
Standard Toolbar Icons
	Checks and corrects the spelling within your text. Place your cursor in a field containing the text and click the Spell Check icon.
	For translating the text to the language of your choice, click Text Translation.
	Displays an entire list of AER’s (recent and selected) and their statuses.
	Closes the currently opened form.
	Updates the case you opened with the latest information.
	Automatically synchronizes and recalculates the Labeling records of a case in ARISg with the details entered in the CPD. The color of the icon changes from Green to Red indicating that the labeling records will be synchronized on saving the case.
	Automatically codes the MedDRA terms in the application.
	Displays the Activity history for an active AER, including all the pending and completed activities related to the current AER. In the Activity History page, you have an option to view all the communications associated to the case in the read-only format. Click the Communication History button to open the Communication History dialog box displaying the communications associated to the case.
	Attaches a document to the currently opened case.
Literature Toolbar Icons
	Opens the page for entering the literature registration information.
	Helps you to retrieve the literature by searching based on Author, Reporter, Patient, Evaluation and Study Report.
Reporting Toolbar Icons
	Prints the FDA (3500a) safety information and adverse event reporting program report. This report notifies the FDA of adverse events related to the use of drugs and/or devices marketed in the United States. The report opens in Adobe Acrobat® allowing you to view and print.

Toolbar Icons	Description
	Prints a Vaccine Adverse Event report. The report opens in Adobe Acrobat® allowing you to view and print.
	Prints a German Federal Institute for Drugs and Medical Products report.
	Prints MedWatch Report.
	This general-purpose regulatory report informs the authorities on the drugs and details corresponding to reactions. The application allows you to generate the CIOMS LL report in other languages depending on the settings in User Preferences.

Refer the Keyboard shortcuts of ARISg_Applications.xls for shortcut keys used across ARISg, Workflow, and QBE modules.

Restrictions For Multiple Login to ARISg and Admin application

When the first login session of ARISg and Admin application is still active, the user may login again using the same credentials in the following scenarios:

In both the scenarios, the case activity (For example: ARISg – AER opened; Admin – Library pages opened) being performed in the first active session is automatically locked and you are not allowed to perform any critical operations such as Case Saving, Complete activity and User Preference as the session is void.

When an ARISg or Admin application login instance is active and the user attempts to open another instance of ARISg or Admin application using the same login credentials of the first active session, a window is displayed prompting the user to either continue with the new login session or Cancel.

Choosing Continue with Login option opens a new instance of the application where all the cases or pages locked in the previous session are unlocked. Where as Cancel will redirect you to the respective application login screen.

Field	Description
Title bar	Displays the current case you opened.
Search approved AERs	Helps you to perform a quick search on the approved AERs. Enter the search criteria and click the arrow button. The List of Selected AERs window appears, displaying the approved AERs.
Workflow	Opens the Workflow Status window displaying the list of cases assigned to you.
QBE	Opens the QBE window, where you search (using simple techniques, advance techniques and using operators) and execute queries.
Alerts	Depending on the configuration in Alerts application, you see the Alerts icon blinking whenever you insert, update or delete the case information. You also receive an alert message in your mailbox indicating the change performed.
agEncoder	From ARISg, you send the terms for coding to agEncoder manually or through a scheduled activity completion in workflow. To manually send the terms for coding, click the option Submit to agEncoder in Tools menu.
Home	Displays the personal homepage with interactive views (iViews).
User reports	For quick generation of custom reports, click the User reports icon. The User Reports Selection window opens for you to choose the report and specify the output format.
Admin	Opens ARISg administrator for customizing the application.
Data Entry Fields	You enter the adverse event information in the Data Entry fields.
Status Bar	Displays your username and database details.

Accessing Machine	Logging Applications	Login User IDs	Scenario	Login Status
Machine A	ARISg or Admin	USER A1	New login instance to ARISg.	Successful
Machine A	ARISg or Admin	USER A1	Login to ARISg or Admin application without logging off the previous ARISg or Admin application in the same machine (Machine A).	Intermediate window appears. Click continue to proceed with the new login session. NOTE: Any critical operation performed in the first active will redirect to the login page of the respective application.
Machine A	ARISg or Admin	USER A1	Login to ARISg or Admin application in different Machines (Machine A and B) using different User IDs.	Successful
Machine B	ARISg or Admin	USER A1	Login to ARISg or Admin application (Machine B) without logging off the previous ARISg or Admin application in the same machine (Machine A).	Intermediate window appears (Machine B). Click Continue to proceed with the new login session on Machine B. NOTE: Any critical operation performed in the first active session (Machine A) will redirect to the login page of the respective application on Machine A.

Getting Started

Logging into ARISg

Toolbar Icons

Standard Toolbar Icons

Toolbar Icons

Restrictions For Multiple Login to ARISg and Admin application