Specifying the Format for CIOMS Report

Specifying the Format for CIOMS I Report

Click New Format button and select CIOMS in the format type. The format details screen appears as shown below.

The table below describes the specific fields available for CIOMS format type in the above Format detail screen.

Note: Refer description for other fields from the section New Format Details.

Field	Description
Print AER Number on top of the report	The place where the AER number has to be printed in the report. The available options are: Yes: To print the AER number on top of the report. No: To restrict the printing of AER number on top of the report. When distributing an E2B or Extended E2B formats through Distribution server, the application generates the CIOMS report and stores in the CIOMS_BINARY_FILE field of AGX_CONTACT_MESSAGE table. If Route through format authority is not available, then the application considers the E2B authority for generating the CIOMS report. By default, the application considers the Print AER Number on top of the report as No for generating CIOMS report.
Ignore not relevant in CIOMS Report	The Study department prints all the records in the regulatory reports whereas the Post Marketing department prints only those records that have the "Not relevant flag" option selected in CIOMS report. The available options are: Yes: To consider all the records marked as not relevant for CIOMS report generation. No: To reject the records marked as not relevant for CIOMS report generation. When distributing an E2B or Extended E2B formats through Distribution server, the application generates the CIOMS report and stores in the CIOMS_BINARY_FILE field of AGX_CONTACT_MESSAGE table. By default, the application considers the Ignore not relevant in CIOMS Report as No for generating CIOMS report.
Print Labeling Information on Continuation Sheet	Labeling information is the information associated with product that are printed on the product wrappings or box. This labeling information is regulated by the authorities from various countries for the accuracy and authenticity of the information related to product printed by the pharmaceutical companies. Yes: Select to automatically print the labeling information of the product on the continuation sheet of the CIOMS report on distributing the cases added through Propose List and automatic build list. No: Select for not printing the labeling information in the continuation sheet of the report. By default, No option is selected. For manually added contacts, the labeling information is printed when you select the "Print Labeling information on continuation sheet" check box in the ARISg > Distribution page > Add link > Format Details screen.

When a CIOMS distribution contact is manually added in the Distribution list and if the authority for CIOMS is not provided then the application considers the Authority as General.

When a contact is manually added, and if the Format type is E2B or Extended E2B then the option Fax for the Preferred Route is disabled.

Did you find this page helpful?