Defining Conditions

Field	Description
Condition Selection
Condition Name	The name of the condition. This is a mandatory field. Note: The application does not allows you to create a duplicate condition. Supports only "-", space, and "_" special characters for Condition name.
Description	The brief description about the condition. This is a mandatory field.
Condition Rule Type	A condition rule is a predefined parameters against which the case details are validated for populating the contacts in the Distribution list screen for distributing a case. Based on the rule type you select from this drop-down list, the application displays only those conditions. For example: If you choose, Pivot Condition as the rule type, the application displays all the pivot conditions available in addition to the other condition selection criteria you have selected. There are five types of Rules as follows: Advanced Condition – This rule is a combination of complex conditions built using the conditional expression. Pivot Condition – This is a high level mandatory condition rule. Standard Condition – This is a rule created considering the built-in codelist values selected in the case for assigning contacts for distribution. Simple Condition – This is a simplest rule built using a single parameter. Stored Function - Specifies the PL/SQL stored function name. For more information on the condition rules types, refer to the Condition Details field descriptions.
Pivot Condition Type	The Pivot Condition are classified into default condition types based on certain important case data entry fields such as Country of Occurrence, PPD and etc. Each of this field type is a referred as the Pivot procedures. The following are the pivot condition type available in this drop-down list. Approval Information Case Seriousness Country of Occurrence Initial unit Preferred Product Description Product Active Ingredients Protocol/Project Source of AER The application displays all the conditions available under the pivot condition type selected from this drop-down list.
Pivot Condition Values	A specific value assigned to the selected Pivot condition type. For example: If the Pivot Condition Type is Preferred Product Description and the you enter Paracetamol as condition value in this box and initiate the search, the application displays all the Pivot Conditions with the condition type as PPD having assigned with the value Paracetamol.
Condition Details
Condition - The user defined condition.
Product type	Allows you to create a new condition for the product type. The options available are: Drug: To create a new condition for a drug. A drug may be a tablet, syrup, lotion, powder, aerosol etc. Vaccine: To add a new condition for a Vaccine. Device: To create a new condition for a Device. A device can be any medical instrument like a syringe, surgical instrument, medical aides etc. Other: In case the Product Type does not confirm to any of the above categories (Drug, Vaccine, or Device), the product type considered as 'Other’.
Source	Indicates the creating of a condition depending on the source of AER. The available options are: Spontaneous Study Literature Authority Other
Origin	Indicates the origin of the AER. The available options are: Domestic: Specifies the country of occurrence matches the country defined in the format or the default country for the report. Foreign: Specifies the country of occurrence is different from the country defined in the format or the default country for the report. Foreign EU: Specifies the country of occurrence is different from the country defined in the format. The country of occurrence is a part of the EU country list specified in the EU Country Maintenance in ARISg Administrator. Foreign Non EU: Specifies the country of occurrence is different from the country defined in the format. The country of occurrence is not a part of the EU country list specified in the EU Country Maintenance in ARISg Administrator.
Submission type	Indicates the submission type. Possible options are: National Centralized Mutual recognition
Approval from	It is an input parameter for 'submission type' condition to locate the approval submission type either from CPD or AER. The possible options are: CPD- On selecting this option the approval records are considered from CPD. AER- On selecting this option the approval records are considered from AER.
Query text	Indicates the query text of a case from QBE. Steps to generate the Query text 1. Click the QBE/AQE button to invoke the QBE page. 2. Enter the search criteria and click the search button. 3. The query is generated and displayed in this field. Important: Use Describe option to print application generated Query with the count of AERs that satisfies the condition from the AER Selection criteria page. Additionally, you are allowed to Print the query from SQL page. In the printed AER Selection criteria page, the count of AERs (satisfying the query and selected for the report) is displayed as "Not Applicable” from both Print and Describe option. Note: This field is editable and you can also manually enter the query.
Stored function	Specifies the PL/SQL stored function name. Note: The following parameters are passed to this function: AER_ID Query_ID Contact_ID Format_ID
Advanced Condition	Indicates the complex condition for a case from the Advanced Condition Builder.
Standard condition	The Standard condition are the condition which you create considering the built-in codelist values selected in the case for assigning contacts for distribution. In ARISg, the codelists are the standard set of options associated with a data entry field available for you to select for a case. For example: Country (Codelist), the list of all the countries available in this data entry field are the associated codelist values. The standard condition provides you an option to select the Codelist and Codelist values as the parameters or classifications for creating the standard conditions against which the case is evaluated for assigning contacts for distribution. You can also select multiple codelist values by providing the codelist IDs separated by a comma. When creating a contact for distribution, the application sends these codelist values to the database procedure, where the associated standard condition is evaluated before defining the contacts for distribution. Following is an example to create condition based on the labelling country against which the case is evaluated in the database procedure for assigning and displaying the contacts for distribution. To select the Standard condition: Click the Standard Condition radio button. The application enables the fields available in the Standard conditions. Click > to expand and view the fields of the Standard conditions. From the Standard condition drop-down list, select the ISP#10_Labelling Country. You have an option to associate a single or multiple Codelist values to a standard condition. From the Codelist drop-down list, select the Country. All the associated codelist values are displayed in the Codelist values field. From the Codelist values drop-down, select USA. Select the Multi Value? check box to display all the conditions of the Standard Condition associated to the contact in the Condition List drop-down list of the Distributing Rule Mapping screen > Update Condition dialog box. You can view and update only those conditions associated to the contact while you are updating the condition only when this check box is enabled. In the Codelist ID For Multivalues drop-down list, select codelist ID to add multivalue codelist in addition to the codelist value you have selected (i.e USA). From the Available Codes for Multivalues section, select the required decodes and click > to assign and move the selected codes to Assigned Codes for Multivalues section. In the Multiple values box, the codes of the selected multivalue decodes are displayed. Click Save. The application now evaluates the case for containing the codelist value (the country USA) defined in the Standard condition and on satisfying the condition the distribution contact is assigned to the case in the Distribution list page in ARISg.
Pivot condition	The pivot condition is a predefined mandatory procedure based on which you create a condition, and assigning of contacts for distribution is compulsorily dependent on the successful evaluation of this condition. All the other conditions that you create, that is, Simple condition, Stored Function, Advanced Condition, and Standard Condition are the sub conditions that are associated to the Pivot Condition. You can associate each pivot condition with multiple sub-conditions. For assigning the contact for distribution, the application must first mandatorily satisfy the Pivot condition criteria and then followed by the sub conditions associated with the Pivot condition. There are set of predefined procedures available for you to select as the parameter for pivot condition. The following are the Pivot procedures available in the Pivot drop-down: Approval Information Case Seriousness Country of Occurrence Initial unit Preferred Product Description Product Active Ingredients Protocol/Project Source of AER Following is an example to create pivot condition based on selecting the procedure available. For example: Create a pivot condition containing the Country where the AER has occurred as the condition for evaluating and assigning the contact for distributing the case. To create the Pivot condition: In the Condition name box, enter the name for the Pivot condition you are creating. For example: Example1. In the Pivot Condition field, click > to expand and view the fields of the Pivot conditions. In the Condition usage drop-down list, ensure to retain the default option "Reportability/Timelines". NOTE: You must always use the default “Reportability/Timelines” option of the Condition usage for creating a Pivot condition. Click the Pivot Condition radio button. The application enables the fields available in the Pivot conditions. From the drop-down list, select the Country of Occurrence. Click Go. The application displays all the countries associated with the Country of Occurrence in the box listed. The application retrieve all the values that are populated for a pivot procedure from the codelist values in the database. Select the country which you want to consider in the pivot condition for the evaluating the case. Press [Ctrl] and select multiple countries, if required. Click the > to add the values you select as conditions for the Pivot. In the Inclusion type drop-down list, select one of the following option: Include if all – To enable the application to consider all the options included for the pivot conditions as the parameters for evaluating the case and assign distribution contact. Include if any – To enable the application to consider and evaluate the case even if any one of the parameter of the pivot condition is available. Include if none – To enable the application to exclude the parameters of pivot condition added for evaluation. For example: If you add ADIDRYL, AGAFFIN, and ALTIMOL as the products for evaluating the case, and the application evaluates the conditions as follows: Include if all - Indicates all the products you add as parameters for pivot condition are evaluated to verify whether the case contain these countries, and on satisfying the condition the contacts for distribution are assigned. Include if any - Indicates if the case contains one of the products added as parameters for the pivot condition to evaluate for assigning the contacts for distribution. Include if none - Indicates that none of the parameters added in the pivot condition are not applicable for case evaluation. Click Save. The Pivot condition is created and the application now evaluates the case for containing the parameters defined in the Pivot condition. The evaluation process of case assigned to a Pivot conditions include the following: Evaluating the parameters added for the Pivot condition. Evaluate each condition (Standard condition, Stored Functions, Advanced conditions etc.) associated with Pivot condition. After satisfying all the conditions, the application assigns the contacts to case for distribution in the Distribution list page in ARISg.
Labeling from	Indicates from where the labeling records are considered. The possible options are: CPD- On selecting this option the labeling records are considered from CPD. AER- On selecting this option the labeling records are considered from AER. Labeling Country- Specifies the labeling country. The labeling country is considered for calculating due dates in RRM Line Listing report. Note: It is considered for calculating the reporting timeline for RRM report.
Reporting times
Report due (days)	Based on the AER seriousness and Labeling status the days specified in the following option is considered. This is calculated as 'latest received date' plus number of days specified in the condition. This field is used to calculate the 'Case Due Date' and 'Final Case Due date' in "Reporting timelines report and "Due date” in "RRM line listing” report. Serious/Listed: The number of days for reporting the Serious/Listed Case. Serious/Unlisted: The number of days for reporting the Serious/Unlisted Case. Non-Serious/Listed: The number of days for reporting the Non Serious/Listed Case. Non-Serious/Unlisted: The number of days for reporting the Non Serious/Unlisted Case. All: The number of days that is considered in case, if the numbers of days are not specified for any of the above options. For example: The system considers the time frame specified in 'All' if the AER is classified as "Serious /Listed” but the 'Serious/Listed' time frame is not specified for 'report due' in the condition.
Final Report due (days)	Final Report due is calculated as latest received date plus number of days specified in reporting matrix. Specifies the number of days for reporting each of the cases is applicable only for 'EU Vigilance Final report' in "Reporting timelines”. The functionally of these fields is similar to Report due (days). Note: Based on the AER seriousness and labeling status, the corresponding 'Final report due' timeline as specified in the condition, is selected. RRM Line Listing report considers this if the 'AER' is a follow-up AER.
Active	Specifies whether the condition is currently active or not by selecting 'Yes’ or 'No’.
Description	Brief description of the condition.

[Optional] To delete a condition, select the required condition checkbox and then click Delete.

Note: Delete the contact(s) or format(s) associated with condition before deleting a condition.