Configuring Case Processing

This section enables you to configure the case processing fields and items. Select System Configuration -> System Management to view the Common Profile Configuration screen

Note:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders.

Each folder contains all the field labels associated with that section.

To view the list of field names associated with the Case Processing section, click the Case Processing folder in the left panel.

The field names associated with Case Processing Configuration appear in the right panel.

The Case Processing folder has been further categorized into the following sub-folders:

  • Configuring Assessments
  • Configuring Always Show Literature Data
  • Configuring Auto Archiving
  • Configuring Case Numbering
  • Configuring Dictionary Browser
  • Configuring Duplicate Search
  • Configuring Group Data Access
  • Configuring Lot Number Processing
  • Configuring Performance

Field Descriptions

The following table lists the fields available under Case Processing Configuration:

Field or Control Name Description

Create follow-up on unblinding

The available options are Yes and No.

Manually Schedule reports

The available options are:

  • Report scheduling will schedule follow up reports
  • Report scheduling will not schedule follow up reports

Events to Display on Assessment Tab

The available options are:

  • Event Assessment will display all Events
  • Event Assessment will display Diagnosis Events only

Enable Local Unlocking

Provides a system level control permitting local users to locally unlock a case and make any corrections to the previously entered local data. Enables you to select whether to locally unlock a case or not.

The available options are:

  • Yes
  • No

Search product on Case Form

The available options are:

  • Product Name product lookup. Based on products configured in the system.
  • Trade Name product lookup. Based on the licenses configured in the system.

Select Type of WHO drug search for auto drug encoding

The available options are:

  • Default WHO schema
  • Use alternate who tables

Action Item Code when QC info is entered

The available action item codes are listed in the drop-down list box.

Valid Attachment File Types

Allows users to attach files in Case Form with the file types mentioned in this parameter.

SQL to prevent case unlock when reports are pending generation

Allows customization to prevent users from unlocking the case from Case Form, E2B, and LAM if there were reports pending generation.

You can configure this behavior by adding a SQL or database function in the given text field.

  1. If the value returned is greater than 0, then the system shall behave as described below:

    If the Value of Allow forced unlock (Global and Local) is Yes, Report Status (Global or Local) is Pending (i.e. the value from SQL check returned > 0), a warning message is displayed.

    The case is unlocked using the existing "Locked Case" dialog if user selects "Yes" on the warning message. This means that the pending global reports will not be generated on unlock and may be overwritten or removed depending on case data on the subsequent global lock.

    If the Value of Allow forced unlock (Global and Local) is No, Report Status (Global or Local) is Pending (i.e. the value from SQL check returned > 0), the case is not unlocked and an error message is displayed.

    If the Value of Allow forced unlock (Global and Local) is N/A, Report Status (Global or Local) is Generated /Submitted (i.e. the value from SQL check returned 0 or no SQL has been configured), the case is not unlocked.

  2. If the value returned is 0 or no SQL has been configured, the system shall allow users to global unlock the case without any of the other checks.

The default for this configuration will stop the users from unlocking the case if there are scheduled reports pending generation.

DLP_EXPEDITED_E2B_REPORTS is set to 0 (i.e., DLP is not enabled for Expedited Reporting feedback.

The checks for reports pending generation are applicable only when the parameter Run Expedited and E2B Reports on DLP is unchecked (i.e., DLP is not enabled for Expedited Reporting).

Make sure that the name that is being used for the bind parameter is P_CASE_ID.

Generate auto-narrative for the other language without user confirmation

This common profile switch helps to suppress user confirmation during generation of auto-narrative for the other language while the user performs the operation in the English side or Japanese side.

Click Yes to generate or No (default) to not generate the auto-narrative.

If auto-narrative is being performed prior to global lock:

If a user is performing the auto-narrative from the Japanese side of the case form and if the auto-narrative template has any other language other than Japanese configured, and if the new common profile switch "Generate auto-narrative for the other language without user confirmation" is set to "No", the system shall first prompt the user if they wanted to generate the English and other language narratives as well. The system shall proceed with all the non-Japanese language narrative generation steps only if the user chose Yes to this dialog (note that existing generation steps and prompts still hold good) or if the new common profile switch "Generate auto-narrative for the other language without user confirmation" is set to "Yes. If they chose No to the user prompt, the system shall proceed with only Japanese narrative generation (note that existing generation steps and prompts still holds true). If they chose Cancel, the system shall not proceed with auto-narrative generation for any language.

If a user is performing the auto-narrative from the English side of the case form and if the chosen Narrative template has Japanese language configured, and if the new common profile switch "Generate auto-narrative for the other language without user confirmation" is set to "No", the system shall first prompt the user if they wanted to generate the Japanese narrative as well. The system shall proceed with the Japanese language narrative generation steps only if the user chose Yes to this dialog (note that existing generation steps and prompts still hold good) ) or if the new common profile switch "Generate auto-narrative for the other language without user confirmation" is set to "Yes". If they chose No to the user prompt, the system shall proceed with only the non-Japanese (English and all other languages except Japanese) narrative generation (note that existing generation steps and prompts still holds true). Note that the prompt shall not display if Japanese language was not configured in the template. If they chose Cancel, the system shall not proceed with auto-narrative generation for any language.

Truly Local Case (Note: Bind variable :P_CASE_ID must be used in SQL)

Provides a system level control allowing customers to define SQL or PL/SQL block or specify database function to test if a case with suspect Local (Japanese) License product is a Local PRPT case. This field is a multi-line text fields with a limit of up to 1000 characters. It is partitioned by enterprises for multi-tenant customers.

The SQL or PL/SQL block or the database function shall accept a bind variable :P_CASE_ID representing the case from which this switch is being invoked. If the value returned from the configured SQL or PL/SQL block or the database function is > 0, the system shall consider the case with suspect products having local (Japanese) license as a Local PRPT case.

If the value returned is 0, the system shall not consider the case a Local PRPT case (unless there is already a local report pending generation i.e., Scheduled or New data available report states).

If there is no SQL or PL/SQL block or database function configured in this switch, the system shall consider that the switch returns a default value of 1.

The system does not allow illegal data manipulations (e.g., UPDATE/INSERT/DELETE statements) to the underlying Argus schema via this switch.

This switch is also used to determine if a report is a Local report.

Always show Literature Data section on Case Form

When configured to Yes, the application always displays the literature section in the Case Form and Book-in.

Default: 0

Enable Smart Duplicate Search

This common profile switch enables smart duplicate search. By default, it is set to Yes.

Any changes made to this switch have the same impact on all the enterprises.

Threshold to display matching records having score of

This configuration option is an Enterprise-level score threshold displayed under the Smart Duplicate Search - Configuration section.

By default, the record level score threshold is set to 50.

When set, the system displays only records that have the matching score more than or equal to the value set.

You can only input values between 0 and 99 in this field. If you enter a value greater than 99, the following error message is displayed:Enter a value between 0 and 99 for Score Threshold.

If the Enable Smart Duplicate Search option is disabled, then this option is also disabled.

The record leved threshold option applies to the following windows:
  • Intial Case Entry
  • ICSR Pending
  • Local Affiliate Incoming Review
Maximum number of duplicate search records to be displayed

This configuration option is an Enterprise-level score threshold displayed under the Smart Duplicate Search - Configuration section.

By default, the maximum number of records score threshold is set to 100.

When set, the system displays only records that have the matching score more than or equal to the value set.

You can only input values between 0 and 1000 in this field. If you enter a value greater than 1000, the following error message is displayed:Enter a value between 0 and 1000 for Score Threshold.

If the Enable Smart Duplicate Search option is disabled, then this option is also disabled.

The maximum number of records threshold option applies to the following windows:
  • Intial Case Entry
  • ICSR Pending
  • Local Affiliate Incoming Review
Backend configuration for Smart Duplicate Search
Control name Description
Elimination Criteria You can set the DET_COLUMN column value as Null for the DUP_SEARCH_DATA_ZONES table, where the ZONE_NAME element can be set to CM_COUNTRY_ID, CM_RPT_TYPE_ID or CPI_PAT_GENDER_ID to turn off elimination criteria for the following fields:
  • Country of Incidence
  • Report Type
  • Patient Gender
Weights You can update the Weight column value to a valid integer value between one and ten for the corresponding ZONE_NAME element in the DUP_SEARCH_DATA_ZONES table. For example, if DEFAULT_WEIGHT is set to 1, you can increase this value depending on how much weight you want to give to your selected field.
Thresholds

You can update the Thresholds column for the ZONE_NAME element in the DUP_SEARCH_DATA_ZONES table. For example, if the Thresholds for CM_INIT_REPT_DATE is {"name": "cm_init_rept_date", "value":"90", "default_value":"90", "unit":"days"} you can update it to {"name": "cm_init_rept_date", "value”:”60", "default_value":"90", "unit":"days"} to decrease the threshold from 90 days to 60 days for the Initial Receipt Date field.

You can update Thresholds only for the following date or numeric fields:
  • INIT_REPT_DATE (Initial Receipt Date)
  • SAFETY_DATE (Central Receipt Date)
  • ONSET (Event Onset Date)
  • PAT_DOB (Patient Date of Birth)
  • PAT_AGE (Patient Age)
Transposed Date You can update the VALUE column to 0 when the KEY element is set to TRANSPOSE_DATE_ENABLED in the CMN_PROFILE table.

Use the following procedure to configure the case processing options.

  1. Select the required option in Create follow-up on unblinding.
  2. Select the required option in Allow User to regenerate reports.
  3. Select the required option in Manually Schedule reports.
  4. Select the required option in Events to Display on Assessment Tab.
  5. Select the required option in Access on Patient Information.
  6. Select the required option in Search product on Case Form.
  7. Select the required option in Select Type of WHO drug search for auto drug encoding.
  8. Select an action item code from the drop-down list in Action Item Code when QC info is entered. This code will be used to populate the Action Item Code field of the action item created by the system whenever a user adds QC information to a case through the Case form > Products tab. If you do not select any value from the list, then no Action Item Code will be set.
  9. The Auto Upload Letters feature is no longer available. You are requested to select only the Manually Upload Letters option.
  10. Click Save to save the changes made to this section.