Flexible Re-Categorization

To access Flexible Re-Categorization:

1. Go to Argus Console > Code Lists > Argus > Flexible Re-Categorization.

   The following table describes the fields associated with this section.

   Field Name	Description
   Code List Name	This is a drop-down list that displays all the available flexible code lists for selection.
   Attribute Name	This is the language Decode context for selected code list which can have language code and other properties of code lists. The following are possible values for this field for the factory data rows which will be populated based on the current code list factory data. Customer can add more language/type values for the new code list items that they create from flexible re-categorization screen, based on their usage: en: English display value for a code list item jp: Japanese display value for a code list item cn: This attribute provides Chinese text used in NMPA E2B(R3) reports. It is present in the Formulation, Route and Manufacturer flexible codelists. E2B: E2B code value for this code list item RPT: Display value for Reports ISOA2: A2 country code for the country code list items ISOA3: A3 country code for the country code list items EN_ABBRV: This is used for defining abbreviation values. SM: This decode context is used by Oracle Argus Mart while populating data into the SM tables. UCUM_CODE: UCUM code value for this code list item. This is used in E2B(R3) and eVAERS reports. E2B_R3: E2B(R3) value for this code list item. This is used in E2B(R3) and eVAERS reports. VAERS_CODE: VAERS Code value for this code list item. This is used in eVAERS and VAERS report mapping. NCI_CODE: NCI code value for this code list item. This is used in eVAERS reports. MDFS: MDFS code value for this code list item. This is used in MFDS E2B(R3) reports. NMPA: NMPA code value for this code list item. This is used in NMPA E2B(R3) reports.
   Code List Display Value	This is the re-categorized display value for the code. This display value shall be based on a code list, code, and language combination.
   Add Attribute	Enables you to add a language attribute.
   Remove Attribute	Enables you to remove a language attribute.
   Attribute Name	This is the language Decode context for selected code list which can have language code and other properties of code lists.
   Code	This is the first column in the gird for all flexible code lists. This column displays the internal id for the existing 'Code' list value. For custom code list, the application always populates the code columns with system generated unique sequence value for the selected code list. It is possible for customers to provide a custom 'Code' value for any of the new rows. This value is always unique for a code list.
   <All Language Attributes>	All the language attributes are displayed as a new column in the grid with Primary attribute being the first one after the Code column.
   Right-click > Make Primary	Allows you to make the selected language attribute as the primary attribute. The primary attribute column is moved as the first attribute in the grid after the 'Code' column. This configuration is available every time the user opens the same flexible code list.
   Right-click > Make Preferred	Allows you to mark the selected cell values corresponding to selected language attribute as Preferred in the database. Preferred values are displayed with an asterisk (*) in the grid for easy identification. At any given time, only one value can be marked as preferred within matching values for a language attribute.
   Export to Excel	Enables you to export all the values of selected code list into an excel file.
   Batch Attribute Update	A collapsible interface, this option displays the list of all attributes available for the selected code list in Flexible re-categorization screen. It also provides a text box called Code List Value, where users can enter the required display value of the code list for the selected attribute.

2. This page is used to add new values or view existing code list values in the code lists.
3. Click Edit. The grid cells of corresponding row become editable for all the attributes added in that code list by the user.

   On clicking Edit, a green tick mark is displayed, along with a red colored, cross icon.

   Click the green tick mark to temporarily save the grid values (until saved into database by clicking Save button). The selected row comes out of Edit mode.

   Click the red colored cross icon to discard any changes made to the selected row. The selected row comes out of Edit mode.

   On changing the value of a preferred cell, its preferred status is removed upon saving the grid values.

4. Click Delete to allow the users to delete an entry from the flexible code lists. The Delete icon is enabled for only custom code lists, for which protected flag is set to 0 in CODE_LIST_CODE_ATTRIBUTES table. Click this icon to delete all the attribute values corresponding to the selected row from the database.
5. The Display checkbox is checked by default (except for hidden entries), for a new row added into the flexible code list.
6. Click Save to save all the changes made on flexible code list screen.

The following Code Lists are used/provided for BIP Aggregate Reports:

• REPORT_TEMPLATE: This code list is used for managing various BIP report templates available in the system (OOB + Custom) and assign an Oracle Argus periodic configuration (ICH PSUR or CTPR) using which user want to execute this report template. Whenever a new report template is added in BIP, this code list should be modified for providing report template name, its path and corresponding Oracle Argus configuration.
• ADHOC_LINE_LISTING: All the LISTNAME added in adhoc_line_listing code list are available in the UD Summaries tab of periodic reports configuration for attaching the memorized reports to a particular line listing section of periodic report. User can renames these using flexible re-categorization user interface. System provides four adhoc line listings by default which can be increased using this code list if you have more adhoc line listing sections in your report. Once configured, use Oracle Argus UI for attaching the UD summaries with line listings of your custom report.
• SOC_DISPLAY_ORDER: Use this code list to reorder the printing of SOC in various tabulations.
• AGGREGATE_REPORT_FORMAT: Use this code list to define the report formats which you want to use with BIP reports execution. Make sure to use only those formats which are supported by BI Publisher.
• DOSAGE_STRING_FORMAT: This code list can used to restrict/add the dosage string formats which should be available while BIP report execution. More dosage string formats can be added with the help of custom code. The following dosage string formats are provided out of box which print values for dosage string as mentioned in the EN attribute.

  Code	EN
  Do	Dose
  DoFo	Dose, Formulation
  DoFoFr	Dose, Formulation, Frequency
  DoFoFrRt	Dose, Formulation, Frequency, Route
  DoFoRt	Dose, Formulation, Route
  DoFr	Dose, Frequency
  DoRt	Dose, Route

• UNIQUE_PATIENT_ID_FORMAT: This code list is used to restrict/add the dosage string formats which should be available while BIP report execution. More dosage string formats can be added with the help of custom code. The following dosage string formats are provided out of box which print values for dosage string as mentioned in the EN attribute.

  Code	EN
  CePt	Center, Patient
  InPt	Investigator, Patient
  Pt	Patient
  StCeInPt	Study, Center, Investigator, Patient
  StCePt	Study, Center, Patient
  StCnCeInPt	Study, Country Name, Center, Investigator, Patient
  StCnCePt	Study, Country Name, Center, Patient
  StCoCeInPt	Study, Country ISO Code, Center, Investigator, Patient
  StCoCePt	Study, Country ISO Code, Center, Patient
  StInPt	Study, Investigator, Patient

• LABELING_ALGORITHM: Use this code list to define new labeling algorithm with the help of custom code. Please see labeling algorithms for more information on out of the box algorithms.
• EVENTSERIOUSNESS: This code list is provided as part of factory data and is used for printing the actual value of seriousness defined against a serious event.
• ORGAN_IMPAIRED_HLT: This code list is added for defining the high level terms which needs to be scanned through to find out if event reported falls under organ impairment section or not. This can be used in custom reports.
• BIP_DFLT_VALUES: This code list used for configuring the default values for some of the important fields which are used in various grouping and tabulations. For example, how to handle/print an event without and SOC. Value configured in this code list corresponding to SOC will be used in PBRER/DSUR tabulation for events with undefined SOC.

The following Code Lists are used in reports, such as E2B(R3), eVAERS, VAERS, MIR, eMDR and NMPA reports:

Code List	Description
AGE_UNIT	This code list enables you to capture Age Unit information. An Age Unit displays time in periods such as Year, Month, Day, Hours, and so on with E2B and UCUM code information.
CAUSALITY_SOURCE	his code list lets you capture the source from which the causality information was derived, along with the EU_CODE attribute. For each custom value that you add, you must enter the value of the associated EU_CODE attribute in order to populate this info in the EMA E2B report. The values that can be entered for the EU_CODE attribute need to be in the range 1-6, as permissible values for EVCTM are 1-3, and permissible values for EVHUMAN are 3-6
CAUSALITY_CATEGORY	This code list lets you capture the category of the causality information with the EU_CODE attribute.
CAUSALITY_METHOD	This code list lets you capture the method by which the causality information was derived.
* CODE_SYSTEM	For the current release, this codelist is not used in the application (Case Form, Reports).
COUNTRY	This code list maintains the list of Countries with the ISO A2, ISO A3, GENC3, and EEA attributes.
DEVICE_AGE_UNIT	This code list enables you to capture Device Age Unit information. Device Age Unit displays time in periods such as Year, Month, Day, and Hours with eMDR code information.
DEVICE_SUBCOMPONENTS	This code list enables you to maintain information about subcomponents that are part of a medical device, featuring the CLINICAL SIGN IMDRF CODE and DEFINITION attributes.
DOSE_UNITS	This code list is used to maintain the units of measures used in Dose with E2B and UCUM code information.
ETHNIC_GROUP	This code list is used to maintain information about Ethnicity data of Patient or Parent with NCI Codes information and NMPA information.
ETHNICITY	This code list is used to maintain Race information along with NCI Codes information and NMPA information.
EVALUATION_REASON	This code list is used to maintain the List of reasons for not evaluating devices with NCI Codes information.
FORMULATION	This code list enables you to capture information about the formulations (cream, drop, capsule, and so on) available for a product with NCI Codes information.
GENDER	This code list is used to maintain the Gender with E2B and NCI Codes information.
INTERVAL_UNITS	This code list is used to maintain the interval units that are used as units for Age, Duration, and so on.
LAB_TEST_UNITS	This code list is used to maintain the units of measures used in Lab test.
LANGUAGES	This code list is used to maintain the ISO codes of the languages in which text data entry can be made.
LOCATION	This code list is used to maintain the Anatomical locations in which Vaccines are administered.
LOCATION_EVENT_OCCURRED	This code list is used to maintain the locations where the events occurred. This data is used in the eMDR and the MedWatch Device report.
MANUFACTURER	Enables you to capture information about the manufacturer name. This data appears in expedited and periodic regulatory reports.
MEDIA_TYPE	This code list maintains the file types that can be sent as attachments in E2B(R3) reports with the ICH, FDA, EMA, and PMDA attributes to indicate if attachment types are allowed for these agencies.
MEDICAL_DEVICE_INFO	This code list is used to maintain the risk class of the medical devices.
MILITARY_STATUS	This code list is used to maintain the details of the Military status of the Patient such as Active Duty, Reserve, National Guard, TRICARE Beneficiary, and Other with NCI Codes information.
NULL_FLAVOR	This code list stores the different null flavors such as UNK, NA NASK, and ASKU. Null flavor sets are attributes in the Null Flavor codelist which are used to create sets with various combinations of Null Flavors. The Null flavor set can be assigned to Case Form fields in Field Properties Configuration and users can select the Null flavors associated with a Null Flavor set as a part of Case Form data.
PRODUCT_IDENTIFIER_TYPE	This code list identifies the type of Product name being used such as Medicinal Product Identifier (MPID), Pharmaceutical Product Identifier (PhPID).
PRODUCT_NAME_PARTS	This code list specifies the name of a product as a separated component such as container name, form name, device name, invented name, scientific name, trademark name, intended use name, scientific name and so on.
PURCHASED_WITH	This code list is used to maintain the Funds from which Vaccine was purchased.
RELATION	This code list is used to maintain the Reporter relation to Patient.
REPORTER_INFORMATION	This code list is used to maintain the Reporter information such as First Name, Last Name, and so on.
RISK_CLASS_TYPE	This code list captures a list of values for the risk class type with attributes such as MDR and IVDR.
REPORTER_OCCUPATION	This code list is used to maintain the Occupation with NCI Codes and Device Operator information.
ROUTE	This code list enables you to capture information about how a drug is administered to a patient such as auricular, cutaneous, dental and so on with E2B and NCI Codes information.
SPANISH_STATES	This code list lets you capture the states of Spain with the STATE_CODE attribute.
ITALIAN_STATES	This code list lets you capture the states or proviances of Italy with the STATE_CODE attribute.
SPECIALIZED_PROD_CATEGORY	This code list is used to maintain details of the Product category details as per FDA specifications such as Convenience Kit of Co-Package, Prefilled Drug Delivery Device/System, Drug/Biologic Combination, and so on with NCI Codes information.
US_STATES	This code list lets you capture the states of USA with the STATE_CODE attribute.
VACCINATED_AT	This code list is used to maintain the Vaccination Facility Type information.