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.
|
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 |
Protect Reporter and Patient Confidentiality |
Enables you to configure Protect Reporter and Patient Confidentiality
|
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.
|
Origin of Events to Include - Foreign |
Enables you to select the inclusion of domestic or foreign cases based on their country of incidence.
|
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.
|
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:
|
Seriousness - Fatal/Life Threatening |
Enables you to check if case level seriousness assessment is 'Death or Life Threatening'. The possible values are:
|
Seriousness - Serious (Case) |
Enables you to check if case level seriousness assessment is 'Serious'. The possible values are:
|
Seriousness - Serious (Event) |
Enables you to check if the event level seriousness assessment (for any event) is 'Serious'. The possible values are:
|
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 - 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
|
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:
|
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:
|
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:
|
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