1. Administration Guide
  2. Business Configuration
  3. Configuring Expedited Report Rules
  4. Field Descriptions

Field Descriptions

The following table lists and describes the fields in this section.

Field or Control Name Description

Report Name

Enables you to view or enter the name of the Report.

Report Destination

Enables you to select the name of the agency to which the report will be scheduled.

Active

Enables you to specify whether the configured rule is active or inactive.

  • Only active rules are considered for report scheduling.
  • Inactive rules are not checked when the report scheduling algorithm runs.

Auto Distribute Reports

Enables you to distribute reports automatically. Except the E2B Reports, all the Expedited Reports that are selected for auto-distribution are tracked under the Worklist > Bulk Transmit screen. The E2B Reports which are transmitted automatically, are tracked from Worklist > Bulk Transmit E2B.

Protect Reporter and Patient Confidentiality

Enables you to configure Protect Reporter and Patient Confidentiality

  • If this option checked and a report is generated or draft is viewed, the Patient and Reporter information will be hidden.
  • This option will override the check-boxes on the case form (for Protect Reporter and Protect Patient) if it is checked.
  • If this option is unchecked, the Case Form check-boxes will take effect.
  • The Reports listed below will check for the Reporting Rule Confidentiality Flag:
    • EU Device Initial
    • EU Device Final
    • French CERFA Report
    • CIOMS Report
    • MedWatch Report
    • Vaers Report

HCP Case

When checked, the system check for any reporter in the case where HCP=Yes. This enables the report to be scheduled if other parameters for the reporting rules are satisfied.

The default is unchecked.

Report on Drug Not Administered

If this checkbox is checked, system schedules report for the suspect products (study or non-study products) that are marked as 'Drug not administered' along with the other suspect products in the case.

If this checkbox is unchecked, system ignores suspect products (study or non-study products) that are marked as 'Drug not administered' and Reports are scheduled for other suspect products in the case for which 'Drug not administered' is not marked.

Active Moiety

Enable this check-box to enable rule to act exclusively as an active moiety rule for that country.

When this option is enabled the system will disable and ignore the county when evaluating the domestic/foreign causality sections. Listedness will be evaluated at the case level.

No Follow-up or Downgrade

The system does not schedule a follow up or a downgrade report for the case when the the initial report was scheduled based on the current rule.

Origin of Events to Include - Domestic

Enables you to select the inclusion of domestic or foreign cases based on their country of incidence.

  • Domestic: The event is marked as Domestic, if the country of incidence appears in the list of selected countries.
  • This list is displayed in the Countries tab, in the List Maintenance Licenses (section) for the license(s) of the suspect product(s) under examination.

Origin of Events to Include - Foreign

Enables you to select the inclusion of domestic or foreign cases based on their country of incidence.

  • Foreign: The event is marked as Foreign, if the country of incidence does not appear in the list of selected countries.
  • This list is displayed in the Countries Tab on List Maintenance License (section) for the license(s) of the suspect product(s) under examination.

Timeframe

This field specifies the report's scheduled due-date based on the number of days, after the initial receipt or significant follow-up date.

Adjust due date for Group 2 countries by xxx days

This field allows you to specify the number of days by which the due date for a report may need to be adjusted for a Group 2 country.

Form

This is the drop-down list of expedited report forms.

Local Comment Type

This field is used to extract the local evaluator comment from case data (French CERFA 65-0044, CIOMS-I (Local)). This field is only enabled for CIOMS-I (Local) form.

Clinical Reference Type

This field is used to get information from the study configured for a case. This field is enabled for CIOMS-I and other forms.

Language

Enables you to select language type.

  • English is the default language of choice.
  • The system does not support other languages at this time.
  • Reports such as the German BfArM, German PEI, and French CERFA can utilize some field values in their corresponding language (For example: narrative).

Message Type

Enables you to select the message type.

Note:

This field is displayed when an E2B or eVAERS report is selected as the Report Form. If the Report Form is selected as eVAERS, then the Message type is set to ICHICSR and is disabled.

Listedness

Enables you to check if the license being evaluated for reporting is listed. The possible values are:

  • Listed
  • Unlisted
  • Ignore (default)

Seriousness - Fatal/Life Threatening

Enables you to check if case level seriousness assessment is 'Death or Life Threatening'. The possible values are:

  • Yes

  • No

  • Ignore (default)

Seriousness - Serious (Case)

Enables you to check if case level seriousness assessment is 'Serious'. The possible values are:

  • Yes
  • No
  • Ignore (default)

Seriousness - Serious (Event)

Enables you to check if the event level seriousness assessment (for any event) is 'Serious'. The possible values are:

  • Yes
  • No
  • Ignore (default)

Seriousness - Severity

Enables you to select a term descriptive of the severity of the event. E.g. Mild, Moderate, severe, unknown.

Product Specific - Family Name

Enables you to configure product specific reporting rules.

Product Specific - Product Group

Enables you to configure product specific reporting rules.

Product Group drop-down always lists the configured Product Groups.

Causality - Most Conservative

If this check box is marked, the system will look at the event level reported causalities, event level determined causalities and case level causalities, and if any of these three causalities is Yes then the case will be considered Reportable.

If checked, the following options are hidden and set to Ignore:

  • Causality as Reported (Event)
  • Causality as Determined (Event)
  • Causality as Reported (Case)
  • Causality as Determined (Case)
  • Causality is ignored when scheduling reports for non - study cases. This only Study cases.

Causality - Include Non-Clinical Trial Cases

Enables you to include the Spontaneous Cases (Non Clinical Trial Cases) for causality assessments.

Causality - Causality as Reported (Event)

Assesses As Reported causality in conjunction with the Listed value (if any) specified in the rule for the license/event combination being assessed. Ignored for non-study cases. Only applies to Study cases. The possible values are

  • Reportable
  • Non-reportable
  • Ignore (default)

Causality - Causality as Determined (Event)

Assesses As Determined causality in conjunction with the Listed value (if any) specified in the rule for the license/event combination being assessed. Ignored for spontaneous, literature and regulatory authority cases.

Ignored for non - study cases. Only applies to Study cases.

The possible values are:

  • Reportable
  • Non-reportable
  • Ignore (default)

Causality - Causality as Reported (Case)

Most conservative of the As Reported causalities in event assessment for ANY event.

Ignored for non - study cases. Only applies to Study cases.

The possible values are:

  • Reportable
  • Non-reportable
  • Ignore (default)

Causality - Causality as Determined (Case)

Case Level Causality, as observed on the Analysis tab for the Case Level Causality.

Ignored for non - study cases. Only applies to Study cases.

The possible values are:

  • Reportable
  • Non-reportable
  • Ignore (default)

Advanced Conditions

This field enables the selection of an advanced condition to further restrict cases that meet the criteria for the rule.

Advanced Conditions - Select

Enables you to open the Advanced Condition Browser.

You can click this button to open the Advanced Conditions browser to select / create an Advanced Condition.

Responsible Group

Enables you to select a group to whom reports scheduled by this rule will be assigned.

Super Rule - Cease evaluation of normal rules upon match

Enables you to provide a super rule.

Reporting Category

Enables you to configure the relevant reporting category.

Device Reporting Category

Enables you to configure the relevant device reporting category.

License Category

Enables you to configure the relevant license category.

Cover Letter

Enables you to use letters that have been configured for reporting template use.

Comments

Enables you to enter reporting rule comments, up to 2000 characters.

Parent topic: Configuring Expedited Report Rules