2 Enter case data

Receipt range—fields descriptions

View pending case

Use Pending tab to create a case, reject a case, and so on. Users other than Workflow Managers can reject a case from the Intake Worklist.

View rejected cases

Import Tab

In Argus J, you can import these literature data files and assess reportability from the loaded data. The system enables you to book-in all necessary data. Select Literature Intake from the Worklist menu to open the New Literature Case Intake Worklist screen.

The following table lists and describes the fields on the New Literature Case Intake Worklist screen.

When using the Import tab, be aware of the following:

• You can filter all column items.

• Tabulation and sorting functions are available for your use.

• All Worklist basic functions are available to you.

• You can use a background process to import.

• The system permits you to import both JAPIC and WMDIS data.

  • If the data format does not match the JAPIC or WMDIS formats, the system does not import the file and places it in the Failures fold with the error description files.

  • The system assumes the contents are valid.

• The system imports the data and stores it in a shared table.

• The system does not validate the data content.

• The system can import .xls and .xslx files for WMDIS.

• When the system imports literature data, it sorts the data by date in descending order (newest at the top).

• If there are multiple items with the same date, the system sorts them by internal sequence number.

• The following right-click options are available in any row:

  • Accept -- Enables you to accept a highlighted. When clicked, the system displays "Accepted" in the Screening column.

    • If a product Family is not specified for the selected item, the system opens the Modify Product family dialog box to enable you to select a valid product family.

    • When an item is marked as accepted and assigned to a use, the system moves the data item to the Proccessing tab and saves the user name and date time stamp (GMT) in the source file.

    • If the system does not assign a user for an item, the data remains on the Import tab until a user is assigned.

  • Reject -- enables you to reject the highlighted item. When clicked, the system displays "Rejected" in the Screening column.

    • When you reject an item, the system opens a Justification dialog box, to enables you to enter or select a justification for rejecting the item.

    • Rejected by the Standard Screening is the default value in the dialog box.

    • Once an item is rejected, the system moves the data item to the Processed tab and saves the user name and date time stamp (GMT) in the source file.

  • Assign User -- Enables you to assign another user to be the owner of the data item. The system opens the ''Reassign" dialog to enable you to assign an owner.

  • Assign Literature Type -- Enables you to specify the Literature Type from the Console J Codelist. When clicked, the system opens the popup so you can assign an owner.

  • Modify Product Family -- Enables you to define a product family for the literature when a Product Family is not available.

  • Print Monitoring Check Report -- Enables you to print the Monitoring Check Report form in PDF format.

  • Multiple Accept -- The Multiple Accept option enables you to accept all selected row items.

    • When the system encounters any accepted items with a Product Family, it displays the following error message: "At least one product family is missing from the selected items. Only items with a product family are marked "Accepted."

    • If the system encounters locked records, it displays the following message: "Data is being used by another user. The system cannot process this data.

  • Multiple Reject -- The Multiple Reject option enables you to reject all selected items.

    • When you reject an item, the system opens the Justification dialog box to enable you to enter a reason for rejecting the item.

    • The default value is "Rejected by the Standard Screening."

    • The justification you enter in this dialog box applies to all selected items.

    • If you are a trying to process locked records, the system displays the following message "Data is being used by another user. The system cannot process this data."

  • Assign Multiple Users -- The Assign multiple users option enables you to assign users for the assessment in the Processing tab for all selected rows.

  • Assign Literature Type to Multiple Items -- The Assign Literature Type to multiple items option enables you to specify the literature type for all selected rows.

  • Literature Duplicate Search -- Enables you to perform a duplicate search.

  The following table lists and describes the fields on the Duplicate

When performing a duplicate search, be aware of the following:

• A duplicate search searches for title, vol, issue, page and publish year and is executed in the Processed imported literature date and the Case Data.

• By default, the system searches processed data.The system enables you to search for case data by selecting a radio button. When you do so, the system displays the data in the table at the bottom of the screen.

• You can modify field content and click the sesarch button as in E2B Duplicate Search.

• You can use the % character to perform a partial search.

• When the system displays the search result, it enables the Reject Literature Information button if it finds at least one duplicate. When you click the button, the system marks the original item "rejected."

• If the result set contains more than 1000 items, the system only displays the first 1000 items.

• When you execute a duplicate search from the Case Data tab, the columns that do not appear in the Case data (Search Equation Number, Document Number, Issue, Screening Owner, and Assessment Owner, are left blank.

• The system displays the generic name for the ingredients in the Case Data.

• The system displays Author J, Title, J, and Journal J in Japanese. If Japanese values are not availble, the system displays the English values.

• When you click "Add Individual Information" button, the system enables you to enter data about an individual piece of literature. The system opens the Add Individual Information dialog box.

• When you click Select, the system opens the Literature Lookup dialog to enable you to select literature from the Code list.

• When you click Add, the system adds the entered nformation to the Import table.

• When you click Cancel, the system closes the section.

Processing tab

The Processing tab enables you to provide information for processing literature data.

The following table lists and describes the fields and controls on the Processing tab.

The following right-click options are available in any row:

• Assessment

• Assessment Result

• Multiple Assessment

• Create Case/Process Unnecessary Assessment

Assessment

When you select Assessment from the drop-down list, the system opens the Justification dialog box.

The following table lists and describes the fields on the Justification dialog box.

Assessment Result drop-down list

The Assessment Result drop-down list includes the following items. The selection you make determines what is mapped to the case form.

Multiple assessment

Selecting this option enables you to assess all selected row items.

Create case/process unnecessary assessment

When you select this option the system does the following:

• If "Assessment" for the Literature data is marked "not necessary," the system moves the data to the Processed tab.

• If Assessment for liter data is marked with any of the other options, the system opens the Book-in screen with all the literature data populated. The system copies the assessment result to Case Data.

• When you select "Create case/Process unnecessary assessment," the system verifies there is a valid Japanese license available to the product family. If the product family doesn't have a Japanese license, the book-in fails and the system displays the following message: "This product family does not have a valid Japanese license."

• If a matching product family does not exist at the time of the book-in, the system does not populate the product on the book-in screen.

• If an assessment is not completed for the literature data you select "Create Case/Process Unnecessary Assement," the system displays teh following message: "Assessment result does not exist."

• When booking is complete, the system presents the following message: "New Case <case name> successfully created. Do you want to open the case?"

• Once the booking is complete the system moves the processed item to the Processed tab.

Processed tab

The Processed tab enables you to provide information about processed literature data.

The following table lists and describes the fields and controls on the Processing tab.

When using the Processed tab, be aware of the following:

• The grid only displays accepted literature data.

• The Status Detail field opens when you highlight a single item.

Study information—field descriptions

Add reporter information

1. In the Reporter Information section, click Select.

2. In the Reporter Lookup dialog box, enter the search criteria, and click Search.

   • All filter criteria you have entered on the Reporter Look Up dialog box are saved as user preferences while it populates the reporter information on the General tab.

     • If you have reporter information in the case, the information appears in the Reporter Lookup dialog box and search is performed.

     • After performing the search the search criteria is retained as user preferences. The next time you perform a search, these preferences appear.

     • When you log out, the user preferences are retained and are available the next time you log in.

     • To clear all the values in the filter elements, click Clear.

   Tip:

   You can choose to search either by Search Cases or by Search List Maintenance.

3. From the search results, select the reporter information, and click Select.

   The selected, pre-defined information is added to the fields.

Reporter information—field descriptions

Enter pregnancy information

1. From the Pregnant drop-down list, select Yes.

   This field is shown as active only after the Gender field in this section is selected as Female.

   The Pregnancy Information section appears.

2. Enter the available pregnancy information in the form.

3. Click OK.

4. In the Neonate Information section:

   • To delete neonate information, right-click the neonate, and click Delete.

   • The changes are tracked to the neonate information in the audit log.

The following list describes the fields on the Pregnancy Information and Neonate form.

Event death details—field descriptions

Other relevant history—field descriptions

Lab data—field descriptions

Product Browser based search

1. In the Products tab, click Select.

   The Product Browser dialog box appears.

2. Click the displayed entities.

   The hierarchy above and below the entity being searched is also displayed. For example, if Product Name is searched, it displays the Product Name as well as the Family Name and Trade Name.

3. Search for Products based on the following criteria:

   • Ingredient

   • Family

   • Product Name

   • Trade Name—Searches the License Trade Name

4. To select all the search criteria, select the Full Search checkbox, and click Select.

5. Select a product from the search result.

6. To remove the entered search criteria, click Clear.

WHO Drug Browser based search

1. To open the WHO Drug Coding dialog box, click Encode.

2. From the Case Form Configuration dialog box where the Dictionaries are selected for encoding, select either the WHO Drug B format or the WHO Drug C format.

3. Enter the search criteria, and click Search.

   You can search for a product based on:

   • Trade Name

   • Formulation/Strength (sequence 3 and sequence 4) of the product

   • Country—The Sales Country Code of the Product as defined in the WHO Dictionary

   • Generic.

     The following criteria are not available for display or searching in the WHO Drug B Format:

     • Formulation

     • Country

     • Strength

     • Generic

     • Medicinal Product ID

     • Product Type

4. To copy the selected drug to the Product tab, click Select.

5. To close the selection dialog box without making any updates to the Product tab, click Cancel.

6. To perform a full search from the WHO Drug browser, select Full Search.

   • By default, a like search is performed (e.g., CUREALL%)

   • You can use the percent (%) sign to perform wildcard searches

   • If you click Full Search, the full search is performed (e.g., %CUREALL%)

7. You can also search for drug formulation and country. This option is available only if you select the WHO Drug C format.

8. To clear the search criteria you entered, click Clear.

9. You can sort the results on all the fields.

Product information—field descriptions

This section enables you to enter information about the drug being used for the case.

Enter product indications

Enter information about the indicator of the adverse event, like:

• Reported Indication—Reported reaction

• Coded Indication—Code for the reaction

Both the values could be different or same.

Enter Quality Control information

To enter quality control information, click Quality Control.

When you enter information in this section, an action item is automatically created in that case with text Case Product <<Product Name>> sent for QC requires follow up. This action item is assigned to the you.

If you do not intend to create any action item, then it add a date in the Product > Quality Control > QC Result Date field.

The Action item code when QC info is entered common profile switch is used to set the action item code as selected in this switch. If this switch is left blank, then no action item code is set.

Enter dosage regimens

Enter product details

Enter study drug information

You can enter a Study Drug for a Non-Configured Study entered in a case and mark a current product as a study drug.

To mark a product as a study drug:

1. Right-click any suspect product in the case.

2. To mark the current product as a study drug, select Make Study Drug.

Make sure:

• The drug type is disabled to make the product a Concomitant or Treatment option.

• Study Drug is a read-only field that contains the product name selected by you.

• For non-configured studies in the case, the following message appears for all study drugs in the case:

  Drug Not Administered.

Enter product information

Enter Quality Control information

See Enter Quality Control information.

Enter product indications

See Enter product indications.

Select product delivered by device

Enter device component information

Device information—field descriptions

• You can enter up to 10,000 characters in the Additional Manufacturer Narrative field.

• The device evaluation codes have been updated to reflect FDA standards. Go to the following link for more information: http://www.fda.gov

• The evaluation method is available is the following site: http://www.fda.gov

• The evaluation results are available at the following site: http://www.fda.gov

EU/CA device dialog box—field descriptions

When you select the EU/CA Device option, the fields on the Case form are printed. A track of the fields and any updates are maintained in the audit log.

Enter product details

This section is the same for the Product Details section under all the tabs - in the Drugs tab, Device tab, and the Vaccine tab.

See Enter product details.

Enter prior adverse events information

1. Enter the relevant vaccination information items in the form.

2. Click OK.

Enter product information

Complete vaccine administration form

Enter vaccine history

Event information—field descriptions

Review a diagnosis-event relationship

You can group events in a case, and/or associate them with particular diagnoses. Your company may determine these or they may be reported to it. This helps in interpreting and reviewing individual case reports. You can also enable the reporting of diagnoses only while retaining database records of individual event terms.

Click the Relationships button in the Event Information section to open the Diagnosis-Event relationship dialog box.

The case must contain at least two events and, at least, one diagnosis. The events related to a diagnosis are listed on top in this dialog box and the symptoms are indented to the diagnoses. You can group events together and associate them with individual diagnoses.

Associate a symptom with the diagnosis

Click the up or down arrows to associate a selected symptom with a diagnosis. In Argus Safety, select the symptom and click Move Up or Move Down.

For example:

Defining a diagnosis-event relationship can clarify an adverse event report. Suppose an initial case report describes a patient suffering from Somnolence, Sore Throat, and Fever.

AE # Diagnosis AE Term (Associated AEs)

1 Somnolence

2 Sore Throat

3 Fever

For reports on all events, they would appear on a CIOMS-I form as:

• Somnolence [SEDATION]

• Sore Throat [SORE THROAT NOS]

• Fever [PYREXIA]

Suppose a Follow-up report then supplies information that the patient also had neutropenia, and had been diagnosed as suffering from agranulocytosis (the cause of the sore throat and fever). The somnolence was considered to be coincidental, and unrelated to any other adverse events.

Neutropenia and agranulocytosis would be entered into the system, and a diagnosis-event relationship established as follows:

These events would appear on a CIOMS I form as:

• AGRANULOCYTOSIS

• [AGRANULOCYTOSIS] [SORE THROAT],

• [PYREXIA NOS], [NEUTROPENIA]

• Somnolence [SEDATION]

This immediately provides a clear clinical picture of the case.

Auto-populate event information

The MedDRA application searches the term dictionary for a match at the Lower level or at the Synonym level. If a match is found, the following fields are automatically populated: Term code, Preferred Term, Included Term, High Level Term, Group Term and Body System/SOC.

Configure regulatory reporting rules

The regulatory reporting rules are mainly configured to look at Seriousness, Listedness, Causality, and Outcome. Out of these, Listedness and Causality can be captured and controlled (using the event assessment section) down to an individual license basis.

This granularity allows individual license holders to override the normal listedness and causality assessment to control the need for submissions to their local regulatory authority. Each affiliate could either suppress the need for a report by demoting the criteria or add the requirement for a report by promoting the listedness or causality.

This serves to promote the global reporting automation while maintaining the level of individual local affiliate control that is often needed.

To obtain an assessment of the adverse event, the product must be in the company's suspect product and the event must be encoded.

Enter death details

1. Check the Death checkbox under Seriousness Criteria.

   The form for Event Death Details appears.

2. Enter information for the items in the form.

3. Click OK to save the entered Death Details.

Enter hospitalization details

1. Check the Hospitalized checkbox under Seriousness Criteria.

   The form for Hospitalization Details appears.

2. Enter information for the items in the form.

3. Click OK to save the entered Hospitalization Details.

Select nature of event

The Nature of Event section enables you to identify the nature of the event from the drop-down list. You can add a maximum of 50 such Nature of Event rows.

Enter event notes

The Details section enables you to enter notes related to the event. If Reported Causality is entered when the case is booked-in, the system transfers it to this field.

Event assessment tab—user actions

Event assessment—field descriptions

Filter event assessment details

Only the assessment rows that match the selected criteria appear in the filtering results.

Enter product-event details

The Product-Event Details tab enables you to capture causality information for a case.

About local fields

A field is identified as a Local field to one or more countries based on a new attribute in the CMN_FIELDS table. The local fields for only Japan are supported in this release.

Customers can configure any field in the Case Form > General, Patient, Products, Events tabs, and in the Analysis > PMDA tab as a Local field for Japan through back-end updates to the CMN_FIELDS table.

The Enterprise copy configuration action will copy these updates as per existing functionality.

If a customer configures a field that could update global value as a local field, it is expected that the customers maintain the integrity of the global data by business SOPs or custom software processes.

All the fields in a case that is not a Local PRPT case are simply treated as global fields.

All Argus J users are considered as having access to edit the Japan local fields.

All Japanese text fields, including J User-Defined fields are considered as Local fields for Japan.

i. All Japanese text fields are the fields that currently has separate _J columns.

ii. All fields from PMDA tab, PMDA Device Information section.

Argus Safety allows selection of secondary LLT (stored in LLT_J or LLT_CODE_J field) or Synonym (SYN_CODE_J) encoding using MedDRA J browser that does not change the base MedDRA hierarchy of English.

The Event Assessment > Listedness field in the tab for the licenses of the local country corresponding to the local user is considered as a local field. However, this field is available for editing for the user only when the local user has listedness privilege for that local country assigned to them via the User Group > Listedness Determination - Countries access and the datasheet associated with that local country license is configured with "Global / No Local Assessment Required" checkbox as unchecked.

The Events tab > Infection and Event Exclusion checkbox are also considered as a local field for Japan.

Any field where an update to a global field can occur is NOT considered as Local field.

All numeric fields, date fields, drop-down fields which share same data value for English and Japan sides are not considered as Local fields.

However, there are exceptions to this rule where some fields that contain global values are available for update to local users and in such a scenario, it is expected that the global value should be protected by customer's business SOPs.

Case classification is such a field that can cause an update to the global value and it is available as a Local field in the application out-of-the-box.

Study section under General tab requires special handling by the application during local editing. Study Name, Study Description, Protocol Number, Clinical Compound Number and Center Name are local fields.

When the study is a configured study, all these fields are disabled for local editing except Center Name (J). Center Name (J) is available as an editable local field.

Product Information section in Products tab requires special handling by the application during local editing. J Drug Code type and the corresponding J Drug Code/OTC Drug Code/Temporary Code (i.e., DRUG_CODE_TYPE_J, DRUG_CODE_J,), J Generic Name and J Product Name fields are local fields.

Any field that is already editable after case lock will remain editable even after local lock.

An auto-narrative generation performed during Japan Local data entry (after global lock) only updates the J field value and does not update the English or any other language field value.

Enter local reports configuration seed data

A new table is seeded to identify Local Reports for Japan:

• Country - The seed data is the country id for Japan (from codelist Countries) for this release.

• Reporting Destination - The script prompts the customer to provide the default value of reporting destination for PMDA.

  Prompt - "Please enter Agency Name for the PMDA reporting destination as configured in the "Reporting Destination" codelist. This name will be used to identify Local Reports for all enterprises".

• Report Form - The seed data is the following Japan reports:

  
  

Enter local users seed data

The upgrade installer script prompts the user to choose if all the Argus J users will be updated to have local locking privileges.

Enter local fields seed data

Note that the CMN_FIELDS are always seeded as part of install/upgrade factory data to identify the Local Fields for Japan and will be present irrespective of if the customer chooses local locking feature or not.

In case of Multi-tenancy, the customer input value is used to set the seed values across all enterprises.

This seeding of Local users data is audit logged with the system user.

After install/upgrade, if the customer has turned on the local locking, the icons in the applicable screens start reflecting the local/global lock status of the case.