C Flexible Data Re-Categorization

This appendix describes flexible data re-categorization.

C.1 Flexible Data Re-Categorization

The flexible data re-categorization feature is used in OOB BIP Aggregate reports to provide the user with greater control and flexibility on the values they want to print in the report. These code lists are configurable through the Argus Safety console.

This code list data storage design can be leveraged to add new and custom code lists or values by applications and customers without adding new database tables and columns.

The following code lists are provided for BIP aggregate reports:

• REPORT_TEMPLATE: Use this code list to manage the BIP report templates available in the system (OOB and Custom) and assign an Argus Safety periodic configuration (ICH PSUR or CTPR) with which you can execute this report template. Whenever a new report template is added in BIP, the system modifies this code list to provide the report template name, path and corresponding Argus Safety configuration.

• ADHOC_LINE_LISTING: All list names added to the adhoc_line_listing code list are available in the UD Summaries tab and can be used to attach memorized reports to a particular line listing section of periodic reports. You can rename these using the Flexible Re-categorization UI. The system provides four ad hoc line listings by default. You can increase them using this code list if you have more ad hoc line listing sections in your report. After configuring them, use the Argus Safety UI to attach UD summaries with line listings of your custom report.

• SOC_DISPLAY_ORDER: Use this code list to reorder the printing of SOCs in various tabulations.

• STATE_2, STATE_3 and STATE_4: These code lists have been modified to print follow-up text, relatedness text, and so on. You can further modify these code list and add new attributes for use in custom reports. For example, you can use the CAUSAL attribute for printing the RELATEDNESS of an event. These are printed as Yes/No or Related/Unrelated using this attribute.

• AGGREGATE_REPORT_FORMAT: Use this code list to define the report formats to use with BIP reports. Ensure that you use formats that are supported by the BI Publisher.

• DOSAGE_STRING_FORMAT: Use this code list to restrict or add the dosage string formats that are available while BIP report is being executed. You can add more dosage string formats using custom code.

  Table C-1 contains the dosage string formats provided out-of-the-box and the print values for each dosage string.

  Table C-1 Out-of-the-box Dosage String Formats and Print Values

  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: Use this code list to restrict or add unique patient ID formats available while the BIP report is executing. You can add new unique patient ID formats using custom code.

  Table C-2 contains the unique patient ID formats that are provided out- of-the- box and the values they print for patient ID.

  Table C-2 Unique Patient IDs and Print Values

  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 algorithms using custom code. For more information on out-of-the -box algorithms, refer to Labeling Algorithms.

• EventSeriousness: A new code list for EVENTSERIOUSNESS is provided as part of the factory data. This code list prints the actual value of seriousness defined against a serious event.

• ORGAN_IMPAIRED_HLT: Use this code list to define high-level terms that are scanned through to find out whether the event reported falls under the organ impairment section. This can be used in custom reports.

• BIP_DFLT_VALUES: Use this code list to configure the default values for important fields used in various grouping and tabulations, for example, to handle or print an event without SOC. The value configured in this code list corresponding to SOC is used in the PBRER/DSUR tabulation for events with undefined SOC.

• Report Type Code list: This code list has been modified to add new attributes and group existing report types into various categories. For example, existing Argus Safety report types have been grouped into the categories of solicited and non-solicited using the CASETYPETEXT attribute.

Updates to Listedness, Seriousness and LM_CAUSALITY code list have been made for printing flags or text values in different line listings.