Report

This section lists the fields descriptions and configuration steps for the Report tab.

Field Descriptions

The following tables lists and describes the fields on the Report tab.

Field or Control Name	Description
Print Case References in the “26. REMARKS” section	Enables you to select the case references to be displayed in the CIOMS I report. The selectable values are populated with the English attributes as configured in the Code Lists > Flexible Data Re-Categorization > Flexible Re-Categorization, REFERENCE_TYPES code list.
Print Event Assessment in the “7 +13 DESCRIBE REACTION(S)” section	Enables you to print the event assessment information in a tabular format in the CIOMS I report.
Print Case Comment in the “7 +13 DESCRIBE REACTION(S)” section	Enables you to print the case related comments in the CIOMS I report. The comment appeared as entered in Case Form > Analysis > Case Comment.
Print Company Comment in the “7 +13 DESCRIBE REACTION(S)” section	Enables you to print the company comments in the CIOMS I report. The comment appeared as entered in Case Form > Analysis > Company Comment.
Print Evaluation in light of similar events in the past in the “7 +13 DESCRIBE REACTION(S)” section	Enables you to print the analysis of the similar events in the CIOMS I report prefixed with text Analysis of Similar Events:. The comment appears as entered in Case Form > Analysis > Evaluation in light of similar events in the past.
Automatically schedule nullification reports on case deletion	Enables you to automatically schedule a nullification report upon case deletion, when a CIOMS I form was previously submitted to the reporting destinations (regulatory authorities and partners). This automatically scheduled CIOMS I report has a due date as two days after the date of scheduling. For example, if the case is deleted on 11-JUL-2024, the CIOMS nullification report is scheduled with a due date as 13-JUL-2024. Text entered in Action Justification during case deletion is populated in the 7 +13 DESCRIBE REACTION(S) section of the CIOMS I form with the prefix, Nullification Reason. This data is not added in the Case Form > Analysis > Case Narrative field. This checkbox is unchecked by default.
MIR Report Format	Enables you to select the MIR Report format from a drop-down list (PDF and XML).
Transmit Non-Company product Causality for study cases	When this checkbox is checked, the causality for non-study, non-company products in the study cases is transmitted in the E2B(R2) and E2B(R3) reports. When this checkbox is unchecked (default), the causality for non-study, non-company products in the study cases is not transmitted in the E2B(R2, R3) reports.
Transmit Non-Company product causality for non-study cases	When this checkbox is checked, the causality for suspect non-company products, non-study cases are transmitted. When this checkbox is unchecked (default), the causality for non-study, non-company products in the non-study cases is not transmitted in the E2B(R2, R3) reports.
Apply EMA Special Rules	When this checkbox is checked, special rules are applied to modify certain data for EU cases if the reports are sent for Agency/Partners from non-EU countries or if the country is not part of the countries list approved by EMA. This checkbox impacts E2B(R2), R2B(R3) and CIOMS-I reports. When you click on the Apply EMA Special Rules hyperlink, a pop-up appears having details of the impacted profile and elements with rule description.
Transmit WHO Medicinal Product ID	Enables you to select whether to transmit WHO medicinal product ID and WHODrug version, or not in the E2B(R3) report. When this checkbox is checked the Code System Object Identifier (OID) is also transmitted for the ICH and EMA profiles. This checkbox is enabled when the Message Profile is set to any of the HL7 E2B(R3) profiles. Otherwise, the checkbox is unchecked and disabled.