Managing Cases through Workflow

ARISg workflow helps you to manage a life cycle of a case, through a series of connected steps.  An adverse event case goes through the steps  of receiving initial report (from the reporter), gathering all information, data entry into a computer system, coding reported reaction terms using medical dictionaries, medical evaluation/assessment, informing other affiliates, and finally, reporting to appropriate regulatory authorities.

The workflow designer helps you define the rules which determine the cases you  view and the functions you perform in the ARISg system.  The rules are established by each Company to appropriately reflect their business practices.  

Displaying Cases in Workflow

  1. Login to the application.
    Workflow Status
    Page appears displaying the activities for cases entered in the workflow. Based on the role(s) you are allotted, you see the cases in the workflow.   
     

Note: The workflow status window is displayed automatically on logging in based on the User preference parameter Display workflow status window on login.

  1. Select a  field in the drop down list to sort the records.

  2. Click the Refresh Button or press Enter.
    The records are sorted  based on an Activity, Activity due date, or Case due date. By default, AERs are sorted by AER number, Version number.

Icon Description of Workflow Status page

Searching AERs in Workflow

Listing your Cases in Workflow

  1. In the Workflow Status Page, enter the search criteria in the options displayed. 

  2. If you are a privileged user for data privacy, you can query the cases based on reporter and patient information.
    The application displays all the cases in alphabetical order that match the search criteria. If you are an unprivileged user, the results are restricted from displaying the case listings.

  3. Click the Sort by button.
    The Workflow Caselist Sort dialog box appears.
    Multiple case level fields label check boxes (both standard and custom fields) are available, based on which you can sort the cases. Using the Up and Down arrows you can select and arrange the sequence of these fields’ label check boxes to sort the cases accordingly.

  4. Select the fields based on which you want to sort the cases.

    For example: When you select the Seriousness, Product and Country as the sorting criteria to search for cases, the application searches and displays the cases matching with these three criteria’s. The cases are arranged in the sequence in which these fields are selected in the Workflow Caselist Sort dialog box, that is, if Seriousness is the first option in the order of selection followed by Product and Country, the cases that are retrieved and displayed in the Workflow Status page are also in the same order.

  5. Use and arrows to change the sorting order.

  6. Click Save to save the sorting criteria.

  7. Click Close to close the Workflow Caselist Sort dialog box.

    The Workflow Status page is refreshed and displays the cases according to sort criteria you have selected.

  1. Select the order of listing the cases in the Workflow Status Page.

  2. Select the option My cases to display all the cases assigned to you in the workflow status page.  

  3. Click the Refresh button or press Enter.
    The Workflow Status Page displays all the cases assigned to you.

Workflow status refreshes automatically on completion of a case depending on the following user preference parameters:

Note : When the translation is not available for changed language, D_MIE_AE_TERM database field and reported term fields will display the previously entered terms in Multiple Reaction page for Workflow Case List and QBE screens.

Listing all the Cases in Workflow

  1. In the Workflow Status Page, select the option All Cases to display all the assigned and unassigned cases  to you.

  2. Select the Workflow from the drop-down list.

  3. Click the Refresh button or press Enter.
    The assigned and unassigned cases are displayed in alphabetical order in the Workflow Status Page.

Listing Cases containing Executable Activities

  1. Enter the required options.

  2. Click the Filter button to expand the search options on Activities.

  3. From the Activity Filter drop-down list, select  Work in Progress.

  4. Click  Refresh button or press Enter.
    Lists the cases containing executable activities associated to your role. Your administrator defines the activities for a  specific role in   
    Activity Definition->Role tab. You can open a specific case and complete the activity.    

Listing Cases containing Monitoring Activities

  1. From the Activity Filter drop-down list, select Monitoring.

  2. Click  Refresh button or press Enter.
    Lists the cases containing monitoring activities associated to your role. You cannot update the case. For Example: An activity which does not require user intervention (Reviewing).

  3. From the Activity Filter drop-down list, when you select Both  the application lists the cases containing Executable and  Monitoring Activities assigned to your role.

Listing Cases using  SQL Query

  1. Enter the required options.

  2. Select a Query from the drop down list.(The query saved in the QBE as Workflow List Query in Save SQL Query page appears in the drop down.)

  3. Click Refresh button or press Enter.
    Lists the cases satisfying your query in the Workflow Status Page in alphabetical order.

Note: You can view the results of query for unblinded information, only when you have appropriate (unblinded) privileges.

Listing Cases based on Assigned User/Roles

In Workflow status screen, the option ”Assigned to” allows you to perform the following

Note: The user (s) with Manager Privileges is allowed to assign Cases to other users.

Depending on the privileges you Open, re-assign or self-assign the AERs. You view and assign cases to others only when you have Manager or required Privileges.

To view the AERs that are assigned to the login User, Manager and other Users of the team:

  1. Enter the required options.

  2. Click the Filter button to expand the search options on Activities.

  3. In the Assigned to list, select:

You can view the list of AERs assigned to a specific user by selecting the respective User ID from the list. For example: If User A is Manager, then User B, C and D are the members of the team, then the user can view all these User IDs in the Assigned to list.

Listing specific AERs

  1. Enter the required options.

  2. Enter a specific AER no.
    Or

  1. Enter the range of AERs by using a wildcard character. For Example: ISS% list all the cases which begin with ISS.

  2. Select a workflow from the drop down list.

  3. Select an Activity name from the drop down list.

  4. Click Refresh button or press Enter.
    Lists the AERs related to the selected workflow, which are available to you (based on roles you are assigned). If the Activity field is blank, then a list of all AERs in the workflow process is displayed.  
    If an executable activity is selected from the Activity drop-down list and if you only have monitor access to that activity, you will not be able to complete this activity.  All options in this page that enable you to complete the activity are disabled.

Listing Cases based on Duration

  1. Enter the required options.

  2. Enter the Activity due date.

  3. Enter the Submission due date. For example: enter 01/01/96 - 01/10/96 to retrieve cases within this date range.

  4. Click Refresh button or press Enter.
    Lists all the cases which have submission due date in the specified range.

Note: Regulatory Clock Start Date (RCSD) and Latest Received Dates (LRD) are considered for calculating Submission due date. RCSD is considered for calculation, when LRD is different from RCSD. When RCSD is not available, then LRD is considered for calculating the Submission due date.

Listing Cases based on Product Group Name

Products reported in a case may belong to different groups. The Product Groups/ID are created and the relevant products are added to the groups. You can search cases based on the product group name to which the product recorded in the cases belongs.

  1. Click Filter.
    The section expands to display the filtering options.

  2. Click Product group name lookup and select a product group name based on which you want search cases.

  3. Click Refresh to view the cases associated to the product group name provided in the filtering criteria.

Listing cases based on Latest Received Date (LRD)

The LRD is the day on which the most recent information on the adverse event of a case is received by the company. In the Workflow Status page, you can enter the range of dates (From and To). If any of the dates between this date range match the LRD of the cases the application retrieves and displays all those cases.

  1. Open the Workflow Status page.
  2. Click the Filter button to expand and view the search options on Activities.
  3. In the Latest Received Date boxes, enter the date range.
  4. Click the Refresh button or press Enter.

The application displays all the cases LRDs of which are within the date range mentioned in the criteria. You can open a specific case and complete the activity.

Listing cases based on Initial Unit

The Initial Unit is the company unit that received the information of the Adverse Event for the first time. In the Workflow Status page, using the Initial Unit lookup, you can retrieve all the cases associated with a company unit that first received the information of those cases.

  1. Open the Workflow Status page.
  2. Click the Filter button to expand and view the search options on Activities.
  3. Enter the Initial Unit name.

    Or

    Using the lookup, search and select the Company Unit.
  4. Click the Refresh button or press Enter.

The application displays all the cases associated with the company unit.

Listing Cases based on Company Unit

The Company Unit is a division of a parent Company that has its presence across the globe. The company unit from where a case has originated is referred to as the source company unit. In the Workflow Status page, you can retrieve all the cases received by a source company unit.

  1. Open the Workflow Status page.
  2. Click the Filter button to expand and view the search options on Activities.
  3. Enter the Company Unit name.

    Or

    Using the lookup, search and select the Company Unit.
  4. Click the Refresh button or press Enter to list the cases that originated from this company unit.

The application displays all the cases associated with the source company unit.

In the search result grid, the Source Company Unit column display the name of the company unit from where the case has originated. Adjacent to the Source Company Unit column is the  Multiple Source Company Unit, where an icon "" indicates that the information of the case has been received from multiple company units. You can click on this icon to view the associated company units.

Clearing filtering criteria

When you enter multiple criteria and want to reset all the filtering criteria to their default status, use the Clear Filter button. The application enables this button only when you click the Filter button to expand and view the filtering options.

NOTE: The application does not reset the Workflow Preferences and Workflow Case list search. When you click this button, the "Activity Filter" criteria is automatically set to "Work in progress".

To clear the filtering criteria.

  1. Open the Workflow Status page.
  2. Click the Filter button to expand and view the filtering options.

The application enables the Clear Filter button.

  1. Click the Clear Filter button to reset all the search criteria filters to the default status.

The application display the message "Are you sure you want to clear the search?".

  1. Click Yes to clear the search.
    Or
    Click No to discard the process.

The application clears the search criteria entered in the filtering criteria fields.

Reviewing the Progress of AER Activities

Activity History Page displays all the pending and completed activities related to the selected AER, in all workflows. When the activity is completed, the user responsible for completing the activity is updated in the User Completed column in the Activity History window.

 

To review the progress of the case:

  1.  From the Workflow Status window, select a specific case from the  list.

  2. Click the Activity History button.
    The Activity History window opens.

  3. To view the progress of the activity, select one of the following options:

By default, none of the options are selected which means all the activities are displayed. Accordingly, the cases display in the list.

Opening a New Version of AER

  1.  From the Workflow Status window, select a specific case from the  list.

  2. Click the Activity History button.
    The Activity History window opens.

  3. To start a new workflow with a new version of the AER, click Open New Version button.  
    Creates a new local version of the case and inserts the case in the new workflow. 

  4. For a case already in workflow, select option CASE > Create New Version
    Creates a local version.  This option is disabled if the case is not approved.

When you create a new version of the AER, the AER enters the workflow that is defined by the parameter New Version of AER. 

Note: When an AER is copied, the copied AER enters the workflow based on the parameter set for the new AER.  Access to the initial activity created by the workflow is not required in this case.  If you copy an AER but do not have the privilege to the initial activity, you will not be able to work on the AER.

Opening AER in View mode

  1. To open a case in a view mode.

  2. In the Activity History Page, select an activity from the list.

  3. Click the View button.
    Opens the AER in read-only mode, if you have access to open in read-only mode.

Removing Previous Version of AER from Workflow

  1. In the Workflow Status Page, select a case with multiple versions

  2. Click the Activity History button.
    Activity History Page appear, listing activities in various version of the case.

  3. Select an activity from the list

  4. Click Removing Prev. Version button.

Terminating Cases from Workflow

  1. Select Completed option.
    Different versions of the selected AER containing completed activities are displayed.

  2. Select a version of AER you wish to terminate

  3. Select the Abort button.
    A message appears " Do you really want to abort the case from workflow"

  4. In the Error Message window, Click Yes.
    Abort Workflow Reason
    page appears

  5. Enter the Reason description. 
    The enter
    ed reason description appears in the Activity History page.
    A message appears " Case Removed from the workflow".

  6. Click OK in the message window.
    A message appears "Do you want to re-enter the case from the workflow".

  7. To terminate the case, Click No in the message window.

An option to re-start the workflow for terminated case is also provided, this is applicable in situations where the case cannot be re-routed to a particular activity or must follow a complete workflow cycle again.

To include the terminated case in the workflow again:

  1. Click Yes in the"Do you want to re-enter the case from the workflow" message window
    Workflow Process Entry
    window appears.

  2. To include the case in the workflow, Select a workflow from the drop down.

  3. Click OK.
    A message appears that the case is submitted to the workflow server

Capturing Audit Trail Information of workflow cases

Arisg captures audit trail information of cases which have entered workflow from QBE and re-entered the workflow after aborting from the workflow. Brief Audit Report displays the text ”r;Case is pushed into workflow from QBE/Case re-entered into workflow after abort” for the re-entered case in the reason column of the report.

To capture the information, follow the steps:

  1. Select a case in the Workflow Status page.

  2. Click Abort.
    A message appears asking you to confirm on aborting the case from the workflow.

  3. Click Yes.
    ARISg displays Abort workflow reason dialog box.

  4. Enter the reason in the Reason description field and click OK.
    Message appears on confirming the abort. The application displays another message to re-enter the aborted case into the workflow.

  5. Click Yes and choose the workflow.

  6. Click OK.
    The case is submitted to the workflow.

  7. From the Reports option, select Administration>>Brief audit trail   

  8. In the Brief Audit trail selection, type the re-entered AER number and generate the report.
    The reason column appears  in the report.

Viewing the History of Cases

  1. Select an activity from the Workflow Status Page.

  2. Click Activity History button.
    The Activity History page appears.

  3. To view the History of cases, click Assignment History button.
    The
    Case Assignment History page appears.

Completing Case Activities

  1. From the Workflow Status window, select a specific case from the  list.

  2. Click the Complete Activity button.
    Complete Activity
    window opens.

Note: When an initial activity for a case is automatic then the Complete Activity button is disabled.

The Complete Activity Window consists of the following ready only fields:

Corporate Received date + ((earliest Submission Due Dates or Date) - Corporate Received Date * Completion Duration at Root Activity %).

  1. Enter AER priority.
    The case priority is manually defined.  For example: serious unlabeled cases are defined as priority 1, due to the expedited reporting process for these cases. 

Note:During form customization (in ARISg Administrator), some forms are marked as activity independent.  Such forms are displayed to you if you have access even if the workflow activity does not have the assigned forms.
When the cases are sorted by activity, they are sorted based on "activity display name”and not on Activity ID.

  1. Enter your comments in the Notes field.
    This information you enter in the notes field is carried from one activity to other. Notes is attached only when the activity completion is Manual. Notes is not attached for the below listed activity completion types:

  1. Click Complete button. User Authentication page appears, if the Installation parameter Authentication required for is set to Activity completion only or Both and Authenticate User check box is selected in the Activity Definition page.

  2. To complete the activity, in the User authentication page, enter your login password and click OK button. A Validation Failed window appears, if the case does not meet the pre-defined validation criteria for completing the case in the selected activity.

    When a large number of cases are put into any Workflow, the application displays an appropriate warning message to the user.
    The WF_PROCESS_RECORDS_LIMIT property configures a default threshold of 500 cases in the ARIS.PROPERTIES file.
    The application allows you to change this default value.


    If you select cases from QBE or Workflow Caselist that exceeds the threshold limit and try to associate all cases with the workflow on Complete Activity, then the application displays an appropriate message with Yes and No options.

    On clicking  Yes,  allows you to proceed with the completion of an activity.
    On clicking  No, the application redirects to the result screen to select less number of cases.

    If the WF_SERVER_QUEUE table record count and the selected number of cases are already exist in the Workflow and that exceeds the threshold limit on Complete Activity, then the application displays an appropriate message with Yes and No options.

    On clicking Yes, allows you to proceed with the completion of an activity.
    On clicking No, the application redirects to the result screen to select less number of cases.

  1. In the Validation failed window, click Show Errors button. The Validations window appears. The validations defined at the Workflow level appear in this window. If an activity has failed validations of 'Error' type, the failed validations must be addressed before the activity is completed. If the activity also has failed validations of 'Warning' type, such validations must also be addressed before the activity is completed.

Completing Activities in Batch

To complete activities in several cases in a batch:

  1. Select multiple cases that are in the same activity stage in the Workflow Status window.
    For example: If you are selecting one of the case in the Data Entry activity stage, then select other cases that are in the same activity stage.

NOTE: If you select multiple cases from different activities stages, this may cause undesirable result in the application.

  1. Click the Activity History button.
    The Activity History page appears.

  1. Enter information once for all the highlighted cases.
    A note entered on the first selected case is added to all others as they are processed.
    You are allowed to include the following special characters in the Notes field:
    ~,`,!,@,#,$,%,^,&,*,(,),+,_,=,{,},[,],;,:,”,’,<,>,?,/"

  1. Select the Complete All button.
    A message 'Do you want to complete all selected activities?’ appears.

  2. Click Yes on the message window.
    All the selected activities are submitted to the Workflow Server for completion.
    Completion of an activity for multiple cases has some restrictions.  If manual forwarding is required then all cases can be forwarded only to the same next activity. If one or more cases are locked because another user is working on them, the system will indicate the ones, which are locked.

Working with Notes

Notes are quick and easy way of communicating information to the user of the next activity with a time stamp.

It is useful for reviewers for entering the notes on the case based on the previous data entry related to the case. These routing comments are available across the life cycle with the time stamp and User ID.  

The application provides the facility, to enter notes for all the workflow activities of the case. When the user returns to the same activity multiple times, the previous notes information entered in the same activity appears for editing.

Accessing Notes

You can access Notes window from the following locations.

N o t e:If you hover the mouse over the text, a window pop-ups with the text. The pop-up text displays all the 1000 characters in the chrome browser, whereas IE has a limitation to display only 512 chars.

Each activity displays the following details in the notes window.

The previous notes information entered in the same activity appears for your editing in the Complete Activity screen and when the case is opened.

On completing the activity, you can no more edit the notes and are not available for editing.

The note is maintained for each of your activities.

Note: Notes entered in an activity cannot be edited in the next activity by any user.

For example, USER1 completes Data Entry and the next activity Medical Review is in progress. The application restricts the user from modifying notes entered in Data Entry by USER1, although USER1 has created the notes.

 When you have multiple versions of a case with notes, select Show Current Version Notes to display the notes of the current version.

Select version drop-down to display notes of the specific version.

Use the IRT Notes drop-down to view the notes entered in IRT and OST applications too.

 

Show activities with notes: Select this to display the activities with notes. Activities without notes are not displayed in the window.

If this option is not selected, all the activities are displayed irrespective of the Notes. Notes are displayed in the order of current activity to previous activities (Notes entered last are displayed first).

You cannot modify the contents in the Notes window, you can only view them.

You can print the activity notes by clicking the Print button.

Customizing the Workflow Case List

When you want to add a new field or modify an existing field, then ARISg application allows you to customize the AER fields with data in the workflow case list.

You can perform the following actions on the selected fields:

To customize workflow case list:

  1. On the Workflow Case List, click Work flow preferences.
    Work flow preferences
    page appears.

  1. Click Add link, to add the AER field in the workflow case list.

The following actions with the customized results.

  1. Click Save.
    To save the record in the Work flow Preferences page.

  2. Click Close.
    The Workflow case list page is refreshed and the customized case list appears.

Adding an Existing Case to Workflow

The application is designed to support multiple workflows at a site, to reflect a company’s procedures for handling AE cases.  A default workflow for new cases is specified through the Workflow Definition module in ARISg Workflow Administrator module.  However, you can also initiate new workflows for a case or a set of cases if the processing of these cases needs to be done as per a different pre-defined workflow path.  For example: there might be different workflows for:

You can search for serious and unexpected cases using the ARISg query facility.  Cases can be selected and loaded into appropriate workflow to handle an expedited reporting process.  Such functionality provides an alternative way to load cases into a particular workflow other than the one defined for new cases.

Two routes are available to accomplish this function, depending upon the situation.

From the List of Selected AERs page:

  1. Define the search criteria for cases using the ARISg Query facility.

  2. The List of Selected AERs page appears with the query results.

Note: Notes icon appears on the main toolbar in workflow login of ARISg application, allowing you to launch new Notes window when you open the case from the List of selected AERs and from AER List in the workflow login of ARISg application.

  1. Select all cases or a sub-set of cases from the list box.

  2. Select the Create Workflow button.
    The Workflow process Entry window is displayed.

  1. Select the workflow from the drop-down list and click the OK button.
    The following message box is displayed: Case Submitted to Workflow Server

This will initiate a new workflow for all these selected cases.

  1. In the Workflow Status page, select the appropriate workflow from the drop-down list to change the context to the new workflow for these cases.

  2. You can search for a case providing the search criteria with unblinded information only when you have the appropriate privileges for blinding/unblinding. However, If you do not have the privileges, then you can provide the search criteria only for normal and blinded information.

Note: A particular version of an AER can be entered only once into a particular Workflow at a given time.

Creating workflow for Duplicate cases

ARISg allows you to enter duplicate cases into workflow by displaying a warning message.  

  1. Select a case from the List of Selected AERs page.

  2. Click Create Workflow button
    Workflow Process Entry
    page appears.

  3. Select the Workflow.

  4. Click OK.
    A message appears notifying that the AER already exists in the workflow

    Click Yes to include the selected case in the workflow.
    A message appears confirming the submission of case to workflow.

  5. Click OK to Exit
     

Creating New Versions of Case in Workflow

A new version of a case is created in the following scenarios:

You create a new version of the case, only when you set the following parameters:

To open a new version:

  1. Select a case in the Workflow status page

  2. On the Workflow Status page, Click Activity History button
    Activity History
    page appears

  3. In the Activity History page, click the Open New Version button.
    A new version of the case is created and enters  into a new workflow.

Note:

Multiple Versions of a Case in Workflow

The system supports multiple active versions of cases in Workflow to support conditions that typically occur in a distributed global environment.  For example: consider the following scenario:

If there are multiple active versions of the case in the workflow, one must be careful of updating information on lower versions of the case.  It is advised that case information is always updated on the highest version of the case available so that case information is synchronized among case versions. 

The three functions that are exceptions to this rule are:

This information is 'case centric’ and 'version centric’.  That is, it is maintained for the whole case and is not specific to a single version.

However, you can add or update Authority/Communication/Document records for older versions of the case only if any of the following conditions is satisfied:

Note: When a workflow case is opened from QBE, the application does not modify workflow case data automatically irrespective of being locked/unlocked.

Also, the application does not update the case data when the locked case is opened from the workflow case list.

The application allows adding or updating authority and communication data only when the workflow parameter "Allow data entry outside workflow is enabled”.

Updating Data Outside a Workflow Activity

You can update the latest version of the case outside workflow activity, i.e., when the case is opened from standard AER list. The other accessible forms that are not activity-independent are opened in read-only mode, i.e., you cannot work with those forms.  An AER can be updated even if it is in workflow.

When a locked case is opened outside workflow, ARISg will not allow modification of local, corporate and regional fields.  Similarly, the reassignment of Co-manifestation and reordering are also not allowed.

The system automatically creates a workflow process for all the cases that undergo a change with respect to informed authority data, to facilitate automatic transmission of cases (Authority data updates) to all required affiliates when Authority data is changed.

Note: When a case is opened from the List of Selected AERs page or the Most Recently Used List of AERs page in ARISg Workflow, the Review Distribution List option is enabled, irrespective of whether the Workflow parameter "Allow AER data changes outside the workflow” is set to "Yes” or "No”.

Upon saving the case, the version of the case (for which the Informed Authority record is created/updated) is submitted to the selected workflow process, when an authority record is created/updated outside workflow and when that particular version of the case is not already present in the workflow.

Note: This depends on the workflow parameter "When IA updated outside workflow”, which allows you to select a workflow process to be used for submitting the cases to the workflow that undergo a change with respect to the informed authority data.

The same functionality is applicable if the case is opened from List of Selected AERs or the AER List.

Displaying Communications

In the workflow status window, click  icon to display communications associated with the selected cases.

The following message appears, when you click  icon without selecting a case in the List.

 Please select atleast one AER for which related communications you want to review.

The communication List appears.

The application allows you to perform Forward, Reply, and Follow-up operations on the selected communication.

Note: You must close the case to perform the operations on the selected communication.

Log of Workflows

The system maintains a log of workflows, which records the completed workflows as well as those, which are yet to be completed.  This information is used to display the Activity History of a case.  It lists all the completed and pending activities.  This information applies to all the cases whether in workflow or not.

Tips on Workflow

 

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