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.
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.
Select a field in the drop down list to sort the records.
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
In the Workflow Status Page, enter the search criteria in the options displayed.
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.
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.
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.
Use and arrows to change the sorting order.
Click Save to save the sorting criteria.
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.
Select the order of listing the cases in the Workflow Status Page.
Select the option My cases to display all the cases assigned to you in the workflow status page.
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:
Refresh workflow status window
Refresh frequency in minutes
If both the above parameters are set, the Workflow status screen is automatically refreshed based on the frequency set in the parameter, Refresh frequency in minutes.
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.
In the Workflow Status Page, select the option All Cases to display all the assigned and unassigned cases to you.
Select the Workflow from the drop-down list.
Click the Refresh
button or
press Enter.
The assigned and unassigned cases are displayed in alphabetical order
in the Workflow Status Page.
Enter the required options.
Click the Filter button to expand the search options on Activities.
From the Activity Filter drop-down list, select Work in Progress.
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.
From the Activity Filter drop-down list, select Monitoring.
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).
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.
Enter the required options.
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.)
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.
In Workflow status screen, the option ”Assigned to” allows you to perform the following
Filter and view the all the AERs that are assigned to the login User, Manager and other Users of the team.
Open, re-assign or self-assign the AERs (based on privileges).
Note: The user (s) with Manager Privileges is allowed to assign Cases to other users.
View the status of all the AERs.
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:
Enter the required options.
Click the Filter button to expand the search options on Activities.
In the Assigned to list, select:
All - All the AERs assigned to login User and the other users are displayed.
None - To view the list of unassigned AERs to which the login user is allowed to access.
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.
Enter the required options.
Enter
a specific AER no.
Or
Enter the range of AERs by using a wildcard character. For Example: ISS% list all the cases which begin with ISS.
Select a workflow from the drop down list.
Select an Activity name from the drop down list.
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.
Enter the required options.
Enter the Activity due date.
Enter the Submission due date. For example: enter 01/01/96 - 01/10/96 to retrieve cases within this date range.
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.
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.
Click Filter.
The section expands to display the filtering options.
Click Product group name lookup and select a product group name based on which you want search cases.
Click Refresh to view the cases associated to the product group name provided in the filtering criteria.
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.
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.
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.
The application displays all the cases associated with the 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.
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.
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.
The application enables the Clear Filter button.
The application display the message "Are you sure you want to clear the search?".
The application clears the search criteria entered in the filtering criteria fields.
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:
From the Workflow Status window, select a specific case from the list.
Click
the Activity History button.
The Activity History window
opens.
To view the progress of the activity, select one of the following options:
Detailed: to view the list of all the executable activities
Brief: to view the list of all the monitoring activities
Pending: to view the list of activities which are pending in the workflow process. Once the workflow processing is complete, the set of activity records for the case is moved to the Log of activities
Completed: to view completed activities. The application maintains a log of all the completed activities on all AERs.
By default, none of the options are selected which means all the activities are displayed. Accordingly, the cases display in the list.
From the Workflow Status window, select a specific case from the list.
Click
the Activity History button.
The Activity History window
opens.
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.
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.
To open a case in a view mode.
In the Activity History Page, select an activity from the list.
Click
the View button.
Opens the AER in read-only mode, if you have access to open in read-only
mode.
In the Workflow Status Page, select a case with multiple versions
Click
the Activity History button.
Activity History Page appear, listing activities in various version
of the case.
Select an activity from the list
Click Removing Prev. Version button.
Select
Completed option.
Different versions of the selected AER containing completed activities
are displayed.
Select a version of AER you wish to terminate
Select
the Abort button.
A message appears " Do you really want to abort the case
from workflow"
In
the Error Message window,
Click Yes.
Abort Workflow Reason page appears
Enter
the Reason description.
The entered reason
description appears in the Activity History
page.
A message appears " Case Removed from the workflow".
Click
OK in the message window.
A message appears "Do you want to re-enter the case from the workflow".
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:
Click
Yes in the"Do you want
to re-enter the case from the workflow" message window
Workflow Process Entry window appears.
To include the case in the workflow, Select a workflow from the drop down.
Click
OK.
A message appears that the case is submitted to the workflow server
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:
Select a case in the Workflow Status page.
Click Abort.
A message appears asking you to confirm on aborting the case from the
workflow.
Click Yes.
ARISg displays Abort workflow reason
dialog box.
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.
Click Yes and choose the workflow.
Click OK.
The case is submitted to the workflow.
From the Reports option, select Administration>>Brief audit trail
In the Brief Audit trail selection, type the re-entered
AER number and generate the report.
The reason column appears in the report.
Select an activity from the Workflow Status Page.
Click
Activity History button.
The Activity History page appears.
To view
the History of cases, click Assignment History
button.
The Case Assignment History page appears.
From the Workflow Status window, select a specific case from the list.
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:
Case due date is the date by which the case should complete the workflow. The application calculates the case due date using the following formula:
Corporate Received date + ((earliest Submission Due Dates or Date) - Corporate Received Date * Completion Duration at Root Activity %).
Activity due date is calculated based on the percentage value specified in Completion duration field of Workflow Definition page in ARISg Workflow Administrator module and the earliest submission due date at activity level for the activity.
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.
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:
Automatic Completion
Completed by sub-activities
Completed by Transmit
Completion of root activity
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.
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.
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.
To complete activities in several cases in a batch:
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.
Click
the Activity History button.
The Activity
History page appears.
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:
~,`,!,@,#,$,%,^,&,*,(,),+,_,=,{,},[,],;,:,”,’,<,>,?,/"
Select
the Complete All button.
A message 'Do you want to complete
all selected activities?’ appears.
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.
AER No
Activity
User
Date
Version No
Notes
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.
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:
Add columns
Delete columns
Rearrange the columns
Hide columns
Edit columns
To customize workflow case list:
On the Workflow Case
List, click Work flow preferences.
Work flow preferences page appears.
Click Add link, to add the AER field in the workflow case list.
The following actions with the customized results.
Click
Save.
To save the record in the Work flow
Preferences page.
Click
Close.
The Workflow case list page
is refreshed and the customized case list appears.
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:
New AERs
New versions of AERs
Tracking Case Communications
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:
Define the search criteria for cases using the ARISg Query facility.
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.
Select all cases or a sub-set of cases from the list box.
Select
the Create Workflow button.
The Workflow process Entry window is displayed.
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.
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.
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.
ARISg allows you to enter duplicate cases into workflow by displaying a warning message.
Select a case from the List of Selected AERs page.
Click Create Workflow
button
Workflow Process Entry page appears.
Select the Workflow.
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.
Click OK to Exit
A new version of a case is created in the following scenarios:
On receiving additional follow-up case information from the reporter but the case is locked for transmission or the case is being processed at another site (such as the Central Safety Unit, for medical review).
On Receiving New follow-up information for a case but the case no longer in the regular Workflow cycle.
On Receiving Additional follow-up case information but the case is locked for update because it was reported to an authority.
You create a new version of the case, only when you set the following parameters:
Selected case is the latest version.
Execute access to the selected activity.
Installation parameter Use Unapproved AER Concept is set to Yes.
Only for Approved AERs.
The Installation parameter Condition for adding version set to Only when the AER is locked.
To open a new version:
Select a case in the Workflow status page
On
the Workflow Status page, Click Activity History button
Activity History page appears
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:
You can access Activity History page from AER List, Standard AER Selection page and Workflow Status page.
You can also create a new version of the case from CASE à New Version option. This option is enabled only if the case activity item is opened and when the opened AER is the latest approved version.
The workflow that has to be created for new version is based on the workflow parameters New version of AER for Current Unit and New Version of AER for Other Unit. You should have Execute access to the initial activity of this New Version Workflow. In both the cases, you should have the privilege to create a new version
The New version is made available only for the latest approved version of the case.
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:
Case ABC-001 version 0 should have been transmitted from site A to central site B for Medical review. The case is in the Transmit queue due to a problem with the network at site B. The follow-up case details cannot be updated at the local site on the same case version when in this situation.
The local site must create a new version to add additional information to the case. At this point, there are two active versions of the case in the local (site A) workflow.
The network issue at site B is resolved and version 0 is sent. Medical Assessment is completed and this version is returned to site A. and this joins the local site A Workflow for further processing.
There are now two active versions of the case present in the Workflow.
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:
Informed Authorities information
Communications data
Document data
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:
If the case is opened from workflow case list or
If the case is opened outside workflow and if the workflow parameter 'Allow AER data changes outside workflow’ is selected.
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”.
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.
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.
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.
Case and activity due date calculation can be defined using an Oracle Procedure. This procedure needs to be defined for each activity as an 'activity creation procedure’.
Users that are responsible for an activity in which cases do not frequently appear can be notified by e-mail.
Use of Automatic activities:
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