3 Process case data

Search for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Search Criteria page, enter criteria for your search in any of the following fields:

   • Search For—Select a parameter from the drop-down list and provide a search value in the adjacent text field.

     Tip:

     You can select the Pri/Stdy/Othr/Cntr/Rptr/Pat option from the Search For drop-down to simultaneously search for a value that you specified in the field adjacent to Search For by all these parameters: Project ID, Study ID, Other ID, Center ID, Reporter ID, and Patient ID.

   • Date Range—Select a parameter from the drop-down list, or enter a custom date range in the From and To fields, and click OK.

     Tip:

     Select the Follow-up radio button to search by follow-up dates, including significant and non-significant event dates.

   • Product Family—Select a product category from the drop-down list.

3. To use a new advanced condition query set as criterion for your search, select New from the Advanced Condition drop-down list or click the AC button. See Create a single filter.

4. If necessary, check the Full Search checkbox and enter a value in the field adjacent to Search For to search for cases that contain the specified value in any word order or combination.

5. Click Search.

6. From the search results list, click a Case ID link.

Search for a case assigned to you

1. On the Home/Personal Argus Status page, check the Cases Assigned checkbox.

   Note:

   If the Personal Argus Status Page is not your default home page, go to the Dashboards menu and click Personal Argus Status.

2. From the list of cases assigned to you, click a Case ID link.

   Alternately, enter the exact case ID of the case in the Case Quick Launch field, and click Open.

View assigned and unassigned cases

1. Hover over the Worklist menu, and do one of the following:

   • To view unassigned cases and new worklist items that were assigned but not accepted by users, click New.

   • To view cases that were assigned and accepted by users, click Open.

2. On the New/Open page, enter the required information, and click Search.

3. To select a case by its number, enter a value in the Case Number field.

   Alternately, choose a filter from the available filters list.

View the case workload for one or more individuals or sites

1. Hover over the Dashboards menu, and click Case Workload.

   Note:

   The Case Workload option displays only if you are a Workflow Manager.

2. In the Load Balancing Dashboard section, click the + (plus sign) character next to a parameter top expand it.

   • Week Forecast — Displays the number of cases that Argus Safety estimates for the selected workflow state or group in the next five days.

   • Refresh — Refreshes the number of cases that appear in the Load Balancing Dashboard every number of minutes you specify.

View the workflow status for cases

1. Hover over the Dashboards menu, and select Worklist Group.

2. Select Workflow Status.

3. Enter search parameters in the search case fields, and click Search.

4. To view cases in a specific workflow state, click a bar graph and perform a select from the drill-down menu.

   Note:

   The number of cases displayed changes as cases are updated during case processing.

   Argus Safety saves your preferences when you return to the Workflow Status.

5. To apply additional filters, click More Filtering and use the Ctrl + Shift keyboard keys to make multiple selections.

   • Site—Displays active sites except LAM sites in the Argus Code List.

   • Workflow State—Displays active workflow states except Archived or Closed in Utilities - Configuration.

   Note:

   If you don't apply other filters, the Default Report Configuration filter shows cases for the current month. The cases are evaluated based on their Aware Date value.

6. To go to a specific worklist screen, double-click the Bar Graph.

Route a case to another workflow state

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. From the Case Form, select the Activities tab.

5. To route the case to the next workflow state, do the following:

   1. Select Route.

   2. From the Case Routing dialog box, select the state to which to route the case from the Route to Next State drop-down list.

      Note:

      You can view states that are assigned to sites in the Workflow Configuration only if you are an Enterprise Workflow Manager.

6. To route the case to the previous workflow state, do the following:

   1. Click Return.

   2. Enter your password in the Case Routing dialog box.

   3. Select the user or group the case will be returned to from the Route to User drop-down list.

7. Enter a routing comment in the Comments field.

   Alternately, click Select and choose a pre-defined routing justification from the Select a standard justification drop-down list.

8. Click OK.

9. In the Case Routing dialog box that opens, click OK.

   Note:

   If a case is routed to multiple workflow states or groups, it is counted multiple times in the Week Forecast.

Add a follow-up event to a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. If the case is locked, unlock the case by clicking the Lock icon ( ) in the Quickstart tool bar at the top right of the Case Form.

5. From the General Information section, in the Follow-ups sub-section, click the Add button.

6. In the Case Form Operations dialog box, choose if the follow-up event is a significant one by clicking the Yes or No button.

7. Modify the system date values in the Follow-up Received and Central Received fields as required for the event.

8. To add a justification for adding the follow-up event to the case, check the Amendment checkbox.

   In the Amendment/Follow-up Justification dialog box, enter a comment and click OK.

9. To add more than one follow-up event to the case, click the Add button again and redo steps 5 to 7.

Unblind cases to a study

1. Hover over the Utilities menu, and select End of Study.

2. In the End-of-Study-Unblinding dialog box, select a study from the End-of-Study Unblinding drop-down list.

   Note:

   The End-of-Study-Unblinding dialog box doesn't include cases that are globally or locally unlocked, or pending local or global report submission.

3. In the Dosage Regimens dialog box, click Select and enter the drug dosage information.

4. Click OK and then click OK again.

Copy a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Search Criteria page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. Hover over the Case Actions menu and click Copy.

5. On the Case Copy - Webpage page, enter the number of copies to create and click Yes.

6. On the Case Copy page, select the sections from the case to copy.

   To copy the entire case, click Select All.

7. Click Copy.

   Note:

   Argus Safety copies any blank values from the case to the case copy.

8. In the Case Routing dialog box:

   1. From the Route to Next State drop-down list, select a value to represent the workflow state for the copied case.

   2. From the Route to User drop-down, select a user or user group to return the case to.

   3. In the Comments field, add a justification for the copy action.

      To add a standard text as justification, click Select, choose the standard text from the Routing Justification dialog box and then click OK.

   4. Click OK.

9. If automatic case numbering is disabled, on the Case Form for the copied case, enter a case ID.

Lock or unlock a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Search Criteria page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. From the Case Form, select the Activities tab.

5. From the Case Lock/Close section, click Lock or Unlock.

6. In the Case Locking/Unlocking dialog box, enter your Argus Safety password in the Password field.

7. To add a justification for the case lock or unlock, enter data in the Notes field.

8. If you are unlocking a Case Form, click either button to choose the focus page for significant or non-significant follow-up events:

   • Significant F/U — The Follow-up Received Date on the General tab, with the Significant checkbox checked.

   • Non-significant F/U — The Follow-up Received Date on the General tab, with the Significant checkbox unchecked.

9. Click OK.

Note:

You can also lock and unlock a case by clicking the Lock icon ( ) in the Quickstart tool bar at the top right of the screen.

Delete a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. Hover over the Case Actions menu a second time, and click Delete.

5. In the Action Justification dialog box, enter a justification in the Please enter a justification for performing this action field.

   Alternately, click Select and choose a pre-defined justification from the Select a standard justification drop-down list.

6. Enter your password in the Password field.

7. Click OK.

Undelete a case

1. Hover over the Utilities menu, and select Case Undelete.

2. On the Case Undelete page, enter search values in the fields from the Case Search Criteria section and click Search.

3. Check the checkbox for the case number to restore and click Undelete.

4. In the Action Justification dialog, enter a justification in the Please enter a justification for performing this action field.

   Alternately, click Select and choose a pre-defined justification from the Select a standard justification drop-down list.

5. Click OK.

Formally close a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Search Criteria page, select the options to use as criteria for your search and click Search.

3. From the search results list, click a Case ID link.

4. From the Case Form, select the Activities tab.

5. From the Case Lock/Close section, click Close.

6. Enter your password in the Case Closure dialog box.

7. Click OK.

Print case details for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the search results list, click a Case ID link.

4. Hover over the Case Actions menu, and click Print.

   • To print the Case Form for the case:

     • Select Case Form.

     • From the Print Case dialog box, check the checkbox for each section to print or check the Select All checkbox.

     • If you don't want the print to include product information for the case, check the Blind Study Product checkbox.

     • Click Print.

   • To print the Medical Summary for the case:

     • Select Medical Summary.

     • From the medical summary report, select File and then Print.

Print letters and attachments for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the Case Form for the case, select the Additional Information tab.

4. Click the Print Case icon ( ) at the top of the page.

5. In the Print Case dialog box, select the tab corresponding to the item type to print (Letters or Attachments).

6. Click the Description link for a letter, or the Classification link for an attachment to view the item in Adobe Acrobat.

7. Click the Print File icon at the bottom.

View correspondence contacts for a case

1. Hover over the Worklist menu, and select Contacts.

2. On the Contacts page, enter case information in the fields as necessary.

3. From the results list, click a Case ID link for which to view correspondence contacts.

Generate a letter on a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Selection page, enter the search criteria for a case and click Search.

3. From the results list, select a case.

4. From the Case Form for the case, click the Activities tab.

5. In the Contact Log section, click New Letter.

6. From the Custom Letter Templates dialog box, select a letter template and click OK.

7. From the Save Letter dialog box, click Yes and modify the Argus generated letter as appropriate.

   Alternately, click No to save the Argus generated letter as is.

8. In the Attach Letter for Case dialog box, click Browse and navigate to the location of the saved letter.

   Tip:

   You can then modify the value in the Date Sent field in the Contact Log to schedule an action item for the letter.

Track correspondence for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the results list, select a case.

4. From the Case Form for the case, click the Activities tab and select Contact Log.

View case action items

1. On the Home/Personal Argus Status page:

   • To view your pending action items, check the Action Item Entries checkbox.

   • To view action items for a specific case, click a case number link and then select the Activities tab.

     You can view the details in the Action Items section.

2. From the Worklist menu, select Action Items, then select Worklist, and select Action Items.

   • To view details for a specific case action item, enter search criteria in the relevant fields:

     • S/U/R—Select the case-level assessment values for the case that contains the action items as Serious, Unlisted, Related.

     • Action Item Code—Select the case action item code.

       Note:

       You can modify the Description value that Argus uses for the selected action item code as required.

   • Check the checkbox corresponding to the type of case action item to view:

     • To view only case action items with due dates before the current date, check the Overdue Action Items checkbox.

     • To view only query-type case action items, check the View Query Action Items checkbox.

View revisions for a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the search results list, right-click a Case ID link and select Case Details.

   Alternately, open the case and select Case Revisions from the Case Actions menu.

4. From the Case Details dialog box, click the plus sign (+) next to Revisions.

5. Click the Revision History text to view all the revisions for the case in the Audit Log Details dialog box.

6. Click an entry under Revision History.

   Tip:

   For descriptions of the icons associated with the revisions, see What are the lock states for a case?

7. From the Audit Log Details dialog box, to view details for a specific revision in read-only mode, select the revision from the revisions list.

View the audit log for a case

1. Hover over the Utilities menu, and select Logs.

2. Select View Audit Log.

3. Enter or select search criteria for the log in the Search Conditions section and then click Search.

4. Click the Action item icon ( ) for a case.

5. In the Audit Log Details dialog box, to view details for revisions made on the case on specific date, select the date entry at the bottom of the dialog.

   Alternately, check the checkbox next to the Revisions Date column to view a listing of revisions made on the case through all the dates.

View the coding status of a case

1. Hover over the Worklist menu, and select Coding Status.

2. On the Coding Status page, enter case search criteria.

   Note:

   To filter cases by an advanced condition, click Advanced. Select the advanced condition and click OK.

3. Note the coding status icon for the case.

   For a description of the icons associated with the coding status, see What does the coding status icon indicate for a case?

Perform a medical review of a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Selection page, enter the search criteria for a case and click Search.

3. From the results list, select a case.

4. Hover over the Case Actions menu and click Medical Review.

5. In the Medical Review - Case Form dialog box, to add a narrative to the case:

   • Manually fill in the Narrative text box.

     Tip:

     To enter the narrative in a specific language, click the icon representing the language above the text area.

   • Alternatively, to fill in the Narrative text box with text from an auto narrative template, click Generate.

   1. In the Custom Auto Narrative Templates dialog box, select a template from the list of available templates and click Append. To replace the selected template with a new auto generated narrative template, click Replace instead.

   2. To add information in addition to the narrative, click the Case Comment icon ( ).

   3. If the case has events that are encoded using the MedDRA dictionary, select either 'D' for Diagnosis or 'S' for Syndrome from the D/S field.

   4. To switch to data sheet view and display the License column, click the + (plus) icon for Datasheet.

6. To view a read-only version of the case, click the Temporal View tab.

   1. Filter the data categories to appear in the Event Assessment section by checking the corresponding checkboxes in the Display Options section.

   2. To view details for an event listed in the Event Assessment section, click the Info icon for the event.

   3. Enter information about any relevant tests performed in the Relevant Tests field in the associated section.

7. To attach notes and other items to the case, or to create cross-references to other cases, click the Action Items/Addl Info tab.

Perform a coding review of a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Selection page, enter the search criteria for a case and click Search.

3. From the results list, select a case.

4. Hover over the Case Actions menu and click Coding Review.

5. Click Product Information and review the existing information about the case.

6. To change information about the case:

   1. If the product is not a predefined company product, select a value from the Formulation list.

   2. Enter a value for the indication as reported in Reported Indication.

   3. Enter the indication to be coded in Coded Indication LLT.

   4. To display the associated coding dictionary, click Encode.

7. Click Action Items and review the existing action items for the case.

   • To add an additional action item for the case:

     • Enter the date an action item was created for the case in Date Open.

     • Select an action item code from the Code list.

     • Select a group to be responsible for the action item from the Group/Responsibility.

     • Enter the date on which the action item must be completed in Due.

   • To mark an existing action item for the case as Completed, enter the completion date in Completed.

Perform a regulatory submission review of a case

1. Hover over the Case Actions menu, and click Open.

2. On the Case Open page, enter the search criteria for a case and click Search.

3. From the search results list, click a Case ID link.

4. From the Case Form, select the Analysis tab.

5. To view differences in narratives for the case, in the Case Analysis section, click Show Difference.

   Note:

   The Show Difference button is enabled only if at least one previously locked version exists for the case.

6. To create a MedWatch 3500A Drug Report, select the MedWatch Info subtab.

   1. Enter the following details in block B:

      - If the product caused an adverse event in a patient, in Block B, select Adverse Event.

      - If a product defect or malfunction lead to the death or serious injury of a patient, select Product Problem.

      - If a malfunction or problem of the product caused the death or serious injury of a patient, select both Adverse Event and Product Problem.

   2. In block C, enter medication data in Suspect Medications.

   3. Enter the following information in block F:

      - If you selected Product Problem in block B, enter the National Drug Code in Suspect Medications (NDC#).

      - Select the option corresponding to the origin of the report – User Facility or Distributor.

      - If you don't want the MedWatch 3500A Drug Report to include information from block F, select Suppress Block F Printing.

      - Enter the report number in full as shown in the upper-right corner of the screen in UF/Dist report number.

      - Enter the details of the user facility or distributor reporting site in User facility or distributor name/address.

      - Enter the details of the contact person for medical device reporting (MDR) in Contact person.

      - Enter the date when the user facility's medical personnel or the distributor became aware that the device may have caused or contributed to the reported adverse event in Date aware of event.

      - Click the first row and column of the FDA Patient and Device Codes section and then click Select.

      Note:

      You can enter up to six FDA Patient Codes in the FDA Codes dialog box. If the entered code isn't present in the FDA Codes list, Argus Safety deletes it.

      - If a report was sent to the FDA, check the Report sent to FDA checkbox and enter the date.

      - If a report was sent to the manufacturer, select the Report sent to mfr? checkbox and enter the date.

   4. Enter the following information in block G:

      - Match all report sources in Reporter Type by checking the corresponding Report Source checkboxes.

      Note:

      If the country of incidence isn't the US, the value 'Foreign' appears by default.

      If the primary reported on the General tab is a health care professional, the value 'Health Professional' appears by default.

      Alternately, select Other and enter the necessary text.

      - Enter the PLA number in STN# Pre-1938 / OTC Product.

      - If the product pre-dates 1938, select Pre-1938.

      - If the product is an over-the-counter product, select OTC product.

7. To review information about the history and the current condition of the patient and generate the BfArM 643 form, select the BfArM Info subtab.

   Note:

   If available, Argus Safety uses the relevant information from the Current Medical Status Form on the Patient tab to fill in the fields on the BfArM Info tab.

   1. Enter a causality or modify the existing value from the Causality drop-down list.

   2. Select or modify the existing values that apply to the patient from the drop-down lists in the Check One in Each Category section.

8. To assess imputability for the suspect product, select the AFSSAPS Info subtab.

   1. Check one or more checkboxes in AFSSaPS Information.

      Tip:

      Check the Autres checkbox to enable the corresponding field.

   2. Enter a description in Future Actions.

What is a case owner?

A case owner is the first user to accept a case after book-in. This user has the right to assign the case to another user.

Can I reassign a case to another owner?

Yes, you can reassign a case to another user if you are a Workflow Manager and the initial owner of the case.

When does a case become open?

Argus Safety assigns the Open state to a case when the user accepts their assignment to the case.

How do I create a query-type action item for a case?

Based on the advanced conditions rules for the query-type action item, Argus Safety generates an open query-type action item when you save a case or when you click the Generate Query icon on the Quick Launch toolbar for a case.

The Due Date for the query-type action item is the System Date plus the Due Date (in days) as defined in the codelist. Similarly, the Open Date is the system date on the day the Query was created for the case.

What happens to a query-type action item after its due date has passed?

Once the due date for a query-type action item has passed, Argus Safety:

• Closes the query-type action item, if it doesn't meet the criteria of the Advanced Conditions for the case.

• Attempts to resolve the open query-type action item in the Case Form without creating a new action item with the same name.

How can I view a summary of all the open cases?

To view a summary of all the open cases in PDF format, hover over the Dashboards menu and select Open Case Summary.Cases in the summary are sorted in ascending order as per the number of days each case has been open.

How can I view a summary of cases with open action items?

To view a summary of cases with open action items in PDF format, on your Personal Argus Status page, hover over the Dashboards menu and select Open Action Items.

When can I formally close a case?

You can formally close a case only if the following conditions are met:

• You have access rights to the case.

• Action items for the case are complete.

• Expedited regulatory reports for the case are submitted.

• Expected follow-up information for the case was received.

• The case isn't locked.

Closing a case is the final stage of the case workflow. After a case is closed, Argus Safety archives it.

What happens to a study if I unblind the cases that are associated with it?

If you unblind cases that are associated with a study that is complete and single or double blinded, Argus Safety sets the Blinding Status value of each case to Broken After Study.

How can I track which case revision contains significant follow-up information for the case?

Argus Safety uses the following designations for items in the Audit Log Details dialog box:

• (S) F/U — Significant follow-up information was attached to the case.

• (NS) F/U — Non-significant follow-up information was attached to the case.

Users can mark follow-up information as significant or non-significant on the General Information tab of the Case Form for the case.

Each company can use its own definition of what significant follow-up information represents.

How can I interpret the differences between two narratives for a case?

Argus Safety uses the following conventions to signal the differences between two narratives on the Show Difference page:

• Strikethrough red text with yellow highlight — Narrative text that was removed.

• Regular text with green highlight — Narrative text that was added.

What other case details can I retrieve from the Routing Comments log?

In addition to user justifications for case routing, the Routing Comments log also includes details of any lock/unlock action that a user did on the case, even if that user was a system user such as the AG Service.

Note that the log displays only one entry if a global/local lock or a global/local unlock is applied at the same time to the case.

Can I view the original case from a copied case?

Yes, to view the original case, open the case form, and select the Additional Information tab for the copied case. The original case appears highlighted in the References section.

What are the lock states for a case?

Argus Safety uses the following states for a locked case:

• Local Locked ( )— The case requires follow-up. Any user who tries to access the case will be required to either view it as read-only, or unlock of the case at the local level.

• Local Unlocked ( )— The case is available to other local users.

• Global Locked ( )— The case requires local reporting.

• Global Unlocked ( )— The case doesn't require local or global reporting.

• Global Locked and Local Locked ( )— The case is a Local PRPT case and is locked at both local and global levels for all local countries for the case.

• Global Locked and Pending Local Lock ( )— The case is a Local PRPT case and is locked at global level but pending a local lock for any local country for the case.

Can I apply a local lock on a case that already has a local lock for another country?

Yes. You can apply a local lock on case that already has a local lock only if:

• Enable Local Unlocking is set to 'Yes' for your tenant.

• There are no local reports pending for the case in the country for which the initial local lock was applied.

If I am an Argus Safety Japan user, can I enter local data, copy or modify a case that has a global lock?

Yes, you can enter local data, copy, or modify a case that has a local lock. However, you can't change the Classification value or generate local reports for the case.

If I am an Argus Safety Japan user, can I apply both a local and a global lock on a Local PRPT case that I entered?

Yes, you can apply both a local and a global lock on a Local PRPT case in one step if you select the Perform Local lock additionally for a Local PRPT case option in the Case Locking dialog box.

If this option isn't available, contact your Administrator to set the value for Enable Local Unlocking to 'Yes' for your tenant.

Can I change the outcome of a case as part of my medical review for the case?

Yes, you can change the value of the Case Outcome field based on your medical review for the case.

Argus Safety sets an initial value of the Case Outcome field based on the outcome values of events from the Events tab of the case.

Note that changing the outcome for the case doesn't change the outcome value for any of the events for the case.

Can I change the causality for a case during my medical review?

Yes, if values already exist in the Causality as Reported and Causality as Determined fields on the Medical Review page, you can change them during your medical review.

• Argus Safety automatically adds the text that was added to Reported Causality when the case was booked in. You can select a different value for Causality as Reported, respectively override the text in Causality as Determined if you have the necessary access rights.

• Your Administrator is responsible for maintaining the list of available causalities for a case and for defining which causalities can be reported.

What do the case assessment values stand for?

Argus Safety uses the following assessments values for a case:

• S — Serious

• U — Unlisted

• R — Causality

• A — Unknown

• F — Fatal

• LT — Life Threatening

• H — Hospitalized

Who is the MDR contact person?

The Medical Device Reporting (MDR) contact person is the designated contact for the device user facility or distributor and the person the FDA conducts MDR correspondence with. This individual may not be an employee of the facility.

How does Argus set the Receipt Date for a case?

Argus Safety sets the value of the Receipt Date field based on the state of the Display Initial Receipt Date always option.

• When the Display Initial Receipt Date always option is enabled, and there is follow-up information for the case, Argus Safety uses the value from the Initial Received Date field.

• When the Display Initial Receipt Date always option is disabled and follow-up information exists for the case, Argus Safety uses the value of the latest Follow-up Received Date regardless of the significance of the information.

How does Argus set the Aware Date for a case?

If follow-up information exists for a case, Argus Safety uses the value of the latest significant follow-up information as the Aware Date for the case.

If follow-up information doesn't exist for a case, Argus Safety uses the value of the Initial Receipt Date field as the Aware Date for the case.

How does Argus set the Date Received value for a case?

The Date Received value is the latest Follow-up Date value for the case.

• If there are multiple Follow-up Date values, then the Date Received value is the oldest Follow-up Date value that exists for the case.

• If there is no Follow-up Date value for the case, then the Date Received value is the initial Receipt Date value for the case.

Which actions can I perform on a saved letter?

You can view saved letters in the Uploaded letters folder.

You can edit a saved letter by clicking the corresponding email button in the Contact Log and then editing it in the message editor.

Can I edit or remove a letter after it was sent for a case?

After a letter is sent, you can no longer edit it. You can only remove it manually.

If I change the Date Sent value for a letter, must I also change the Due Date for the action item associated with the letter?

No. Unless the action item that is associated with the letter has already been completed, when you change the Date Sent value for the letter, Argus Safety also updates:

• The Due Date for the associated action item, to match the new Date Sent value.

• The number of days for the action item that is specified in the letter configuration.

Where can I view action items for letters?

You can view action items for letters for a case in the Action Items section on the Case Form for the case. You can view action items for letters across cases on the Action Items page from your personal worklist.

Why do only some action items for a case appear as Sent in Letter?

Action items that appear as Sent in Letter are query-type action items for the case.

Can I auto-generate a letter for a case?

No. For Argus Safety to auto-generate a letter after you save a case, contact your system administrator.

Based on settings, Argus Safety can:

• Auto-generate a letter after a specific number of days since an adverse event is reported for a case.

• Auto-generate a follow-up action item for you to follow up with a correspondent after the letter is sent.

Auto-generated letters are sent to the first correspondence contact by default.

Which actions can I do on an auto-generated letter?

You can view auto-generated letters in the Contact Log section of the Case Form for a case.

You can view or print an auto-generated letter by double clicking the letter icon in the Contact Log section and selecting the associated action from the Letter Preview dialog.

What does the coding status icon indicate for a case?

The coding status icon indicates the state of the term to be coded for a case.

• Red cross mark ( )—The term was coded.

• Green check mark ( )—The term was successfully coded.

• Grey hourglass ( )—Argus Safety submitted the term to Central Coding, but didn't yet receive a result.

• Red stop sign ( )—Argus Safety submitted the term to Central Coding but received an error either from Central Coding or from Argus.

Why does a border appear for a coding action item for a case?

A red border indicates that the respective action item was completed for the case. Oppositely, a green border indicates that the respective action item wasn't completed for the case.

Why is there a green dot in the Notes area of a case summary?

The green dot that appears in the Notes area is an option for the related field. You can click the dot to revert to the initial automatic value for the field, or view previous overriding notes.

Why do only some user names appear in bold in the Case Workload?

User names that appear in bold in the Case Workload are online users who can view the Online Help icon.

Why does the ( ) icon appear as the lock state icon for a case?

The ( ) icon denotes that the case is a Suspected Unexpected Serious Adverse Reaction (SUSAR) case.

Why do some letter icons from the Contact Log have an exclamation mark?

Letter icons that have a green exclamation mark indicate letters that were successfully sent.

Letter icons that have a red exclamation mark indicate letters that are overdue.

Why does an asterisk (*) symbol appear next to the username for some users in the Case Routing dialog?

The asterisk (*) symbol next to a username denotes that the user who entered the routing justification for a case has since received the Disabled status in Argus Safety.

The Medical Review page appears empty for a Case Form

The fields on the Medical Review page are user-defined. To view them, you must first enable the desired fields from Analysis page in the Case Form. The system saves the selection as a default and uses it when you open the Medical Review page for other case.

The narrative text for a case contains blank spaces or placeholders

Blank spaces or placeholders can appear when the narrative text for a case is auto-generated. Argus Safety displays blank spaces for placeholders that are missing data, and actual placeholders if the placeholders are incorrect.

Contact your Administrator to amend the template for the auto-generated narrative text, or to enable auto-generated narrative text to be modified.

I can't change the assessed seriousness of a case

If any Seriousness Criteria was selected for any Event on the Event page for the case, Argus Safety automatically sets the value of Case Serious to 'Yes'. To override this value, contact your Administrator to receive access rights.

I can't change the determined listedness of a case

Argus Safety automatically sets the value of the Listedness Determination field based on the value of entries from the Event Assessment section on the Events tab of the case.

• If any of the entries appear as 'unlisted', the value of the Listedness Determination field is 'unlisted'.

• If all the entries appear as 'listed', the value of Listedness Determination is 'listed'.

• If all the entries have an unknown value, the value of Listedness Determination is 'unknown'.

• In all other cases, the value of Listedness Determination is blank.

To override this value, contact your Administrator to receive access rights.

I can't select the language I need for my text narrative?

If the icon representing the language you need to enter narrative in does not appear for your case, contact your Administrator to set up the respective language in the Argus application.