Calyx RIM Release Notes

Entity Fields and Columns Added: Calyx RIM 7.0

These tables describe fields and columns that were added in this release.

Home Page

Table 1. Tabs
Tab name Column Name Column Type Description Business Rules
Product Families Family Code Read-only text (populated automatically) When you open the Select Entity List > Product Families from the left hand navigation pane, the Family Code field now displays as a column in the table view. N/A
Table 2. Search Menu
Menu Column Name Column Type Description Business Rules
Search > Applications Procedure Type Read-only text (populated automatically) The Search Results page now includes the Procedure Type column. N/A
Search > Events Application Code Read-only text (populated automatically) The Search Results page now includes the Application Code column. N/A
Application Name Read-only text (populated automatically) The Search Results page now includes the Application Name column. N/A
Search > Registrations Application Code Read-only text (populated automatically) The Search Results page now includes the Application Code column. N/A
Application Name Read-only text (populated automatically) The Search Results page now includes the Application Name column. N/A

Entities

Entity Name Field/Option Name Field Type Description Business Rules
Product Family
Show in Tree Drop-down list The option Show in Tree is added to hide product families from being displayed when using the Tree Filter functionality in the Product Family Attributes and Modify Product Family pages. You can use the Show in Tree option to show or hide the product families on the Modify Product Family page. By default, this option is set to Yes.
Package Sets Text (populated automatically, non-modifiable) The Registrations tab of the Product Family Attributes page now includes the Package Sets column. This column displays the value only when the Registration Type is Package Set. The column will be blank on Product Registration Type.
Event Family Type Text (populated automatically, non-modifiable) The Products tab of the Event Attributes page now includes the Family Type column. The Family Type field value display the Product family Type associated with an product.
Family Name Text (populated automatically, non-modifiable) The Products tab of the Event Attributes page now includes the Family Name column. The Family Name field value display the standard product family name recognized internally and across countries.

The Family Name field value is hyperlinked. When selected navigates you to the appropriate Product Family Attributes page.

Family Code Text (populated automatically, non-modifiable) The Products tab of the Event Attributes page now includes the Family Code column. The Family Code field value display the company-specific code for the product family.
Registrations Family Type Text (populated automatically, non-modifiable) The Products tab of the Registration Attributes page now includes the Family Type column. N/A
Family Name Text (populated automatically, non-modifiable) The Products tab of the Registration Attributes page now includes the Family Name column. The Family Name field value is hyperlinked. When selected navigates you to the appropriate Product Family Attributes page.
Family Code Text (populated automatically, non-modifiable) The Products tab of the Registration Attributes page now includes the Family Code column. N/A
Applications Family Type Text (populated automatically, non-modifiable) The Products tab of the Application Attributes page now includes the Family Type column. N/A
Family Name Text (populated automatically, non-modifiable) The Products tab of the Application Attributes page now includes the Family Name column. The Family Name field value is hyperlinked. When selected navigates you to the appropriate Product Family Attributes page.
Family Code Text (populated automatically, non-modifiable) The Products tab of the Application Attributes page now includes the Family Code column. N/A
Associate/Disassociate Products Button The Products tab of the Application Attributes page now includes the Associate/Disassociate Products icon. You can associate/dissociate more than one product regardless of the Product Families to an Application.
Application Code Read-only text (populated automatically) The Applications grid now includes the Application Code column. N/A
Indications/Intended Use Mass Update Action button Mass Update enables you to update a MedDRA version for multiple indications/intended entities simultaneously. You can use Mass Update to enter a MedDRA version. You can then use the option Update and Overwrite to update the new version for all selected Indications or use Update and Preserve to update the new version for only those selected Indications which have no values.
Publishing Settings Library Optimize Font in Paper Output Drop-down list Optimize Font in Paper Output has been added to Publishing Settings Library. Minimize font compatibility issues and provide stability to the process of printing the paper output. By default, the value is No. All assemblies migrated from a previous Calyx RIM version will have Optimize Fonts in Paper Output set to No.
Full Product Presentations XEVMPD Submission Required? Drop-down list XEVMPD Submission Required? enables you to categorize the Full Product Presentations that are ready to submit for XEVMPD. When you try to create or copy Full Product Presentations, the value of this field is automatically set to Yes. This indicates that the XEVMPD data is ready for submission.

Wizards

Entity Name Field Name Field Type Description Business Rules
Create Application Associated Products Multi-select Modifiable The Family Name, Family Code and Family Type columns are added in the Product selection page of the Create Application Wizard. N/A
Procedure Type Drop-down list The Procedure Start Date, Procedure End Date and Procedure Identifier are added to the Create Application Wizard and display if the Procedure Type is indicated as MRP, CP, DCP, or National for all the Application Types except CTA or an IND. The fields are included into Create Application > > Enter values for new application > Create Application.
Copy Task Application Name Read-only text (populated automatically) The Copy Task > Select Event > Select a destination event page now includes the Application Name and Application Code columns. This provides the Application uniqueness confirmation.
Application Code Read-only text (populated automatically)
Move Task Application Code Read-only text (populated automatically) The Move Task > Select Event > Select a destination event page now includes the Application Code column.
Global Project Plan (all types) Application Code Read-only text (populated automatically) The Select Applications > Select an Application grid now includes the Application Code column. N/A
XEVMPD Submission Application Code Read-only text (populated automatically) The XEVMPD Submission > Authorised Product Search Results page now includes the Application Code column. N/A
Update Project Event Country Status Application Code Read-only text (populated automatically) The Select Event Countries > Select the event countries you would like to update page now includes the Application Code column. N/A
Application Name Read-only text (populated automatically) The Confirmation > Clicking Next will peform the following actions: page now includes Application Name. N/A
Application Name Read-only text (populated automatically) The Summary > Summary page now includes Application Name. N/A
Calculate Project Dates Application Code Read-only text (populated automatically) The Select Event Countries > Select the event countries you would like to update page now includes the Application Code column. N/A
Bulk Update Events Application Code Read-only text (populated automatically) The Select Events > Select Events to update page now includes the Application Code column. N/A
Bulk Update Sequences Application Code Read-only text (populated automatically) The Enter Sequences Search Criteria > Select values to refine search page now includes the Application Code column. N/A
Associate Workflow to Events or Sequences Application Code Read-only text (populated automatically) The Associate Workflow > Select Events grid now includes the Application Code column. N/A
The Associate Workflow > Select Sequences grid now includes the Application Code column.
Create Sequence Application Code Read-only text (populated automatically) The following grids now include the Application Code column:
  • Project Attributes > Create Sequence > Select Events grid
  • Project Attributes > Create References for Events > Select Events grid
  • Project Attributes > Create References for Sequences > Select Events grid
  • Project Attributes > Associate Change Detail(s) to Events > Select Events grid
  • Project Attributes > Leaf Updates for Assemblies > Select Sequences grid
N/A
Create References for the Project Events or Sequences
Associate Change Detail(s) to Events
Leaf Updates for Assemblies
Create Study Report Update the sub-folder structure for 5.3.5 Reports of Efficacy and Safety Studies Multi-select check box The Update the sub-folder structure for 5.3.5 Reports of Efficacy and Safety Studies option is added to the Create Study Reports > Enter Properties page. Study reports can be added to specific Indication folders to improve the data setup.
Copy Full Product Presentation Application Code Read-only text (populated automatically) The Copy Full Product Presentation > Select wizard flow > Select the flow for the Full Product Presentation copy you would like to perform > Full Product Presentation under different Registration(s) page now includes the Application Code column. N/A
Copy Registration Attachment Application Code Read-only text (populated automatically) The Copy Registration Attachment Attributes > Select Full Product Presentation(s) where newly copied Registration attachment should be created page now includes the Application Code column. N/A
Import eCTD to Application EAEU XML with embedded PDFs Read-only text (populated automatically) The Enter the eCTD Folder > Choose the eCTD Folder to import page now includes the EAEU XML with embedded PDFs option in the Import Type drop-down list. EAEU XML with embedded PDFs has been added to provide the functionality related to EAEU regulatory updates. You can use EAEU XML with embedded PDFs while importing EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
EAEU XML Location Browse button The Enter the eCTD Folder > Choose the eCTD Folder to import page now includes the EAEU XML Location field. You can use EAEU XML Location while importing EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
DMS Versioning Scheme Radio button The Enter the eCTD Folder > Choose the eCTD Folder to import page now includes the DMS Versioning Scheme field. You can use DMS Versioning Scheme while importing EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
Export Published Output Embed PDFs into EAEU XML? Check box The Export Published Output page now includes the Embed PDFs into EAEU XML? option. Embed PDFs into EAEU XML? has been added to provide functionality related to EAEU regulatory updates. You can use Embed PDFs into EAEU XML? to export EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
Publishing Settings Library Optimize Fonts in Paper Output Drop-down list Publishing Settings Library now includes the Optimize Fonts in Paper Output option. Minimize font compatibility issues and provide stability to the process of printing the paper output. By default, the value is No. All assemblies migrated from a previous Calyx RIM version will have Optimize Fonts in Paper Output set to No.