Calyx RIM 7.2.4 Release Notes

Known Issues

The following general issues and module-specific issues were known at the time this document was published, but (due to time limitations) could not be included in the module-specific user documentation packaged with the software product.

Calyx RIM: Common

Issue Affected Area Description
DE29048 (Added on the 23rd of December, 2022) Notifications wizard The Send to Concerned Parties option includes the Application and Product Family values on the Application Attributes > Notifications > Mail Settings page. This option should display Application only as there is no dependency on Product Family.
DE28641

(Added on the 20th of October, 2022)

Application, Products When all the products are disassociated on the Application Attributes page, the system allows disassociation. No warning messages informing that at least one product should be associated to the application is displayed.
DE27749

(Added on the 19th of April, 2022)

Application, Country For individual users, when the Application Country Rights for Product Families is set to All and Countries is set to any rights, navigating to a county from the Application Attributes > Countries tab results in an error.

Workaround: Set the Application Country Rights for Product Families and Countries to All .

DE29739 Application, Product Family, Create Submission wizard The Create Submission wizard does not work for applications without products when selecting Major Update or Amendment options. When it is opened from:
  • the Application Attributes page, the error message is displayed.
  • any other pages, for example: Home > Wizards > Create Submission, the applications with products can be only selected.
DE27309

(Added on the 12th of January, 2022)

Update Product Details Sets, PDS, Substance When you select Global Project Plan > Modify Substance or Add Substance from Project Attributes page for the Update Product Details Sets project type, not all the fields are displayed in comparison to the Substance page in PDS.
26814 Publishing Using Prepare for Publishing with the Prepare Cross Reference Leafs option selected results in the Unable to extract checksum error if there is a reference leaf to leaf published to Documentum.
26807

(Added on 20th Aug 2021)

Assembly When updating a leaf in an assembly, selecting OnLoad for the Actuate option results in an error message. This is because of the default security settings. Workaround: Update the leaf using API.
26799 eCTD Import After you use the Bulk eCTD Import for TW submission, the Job Status is set to Scheduled instead of Completed. This is because the tw-regional.xml file does not contain the application code.

Workaround: Use Import eCTD to Application instead of Bulk eCTD Import. See: Import eCTD to Application.

26728 Global Project Plan wizard, PDS In the Global Project Plan wizard, when modifying an active ingredient for a PDS the Withdraw Material that is already selected is not shown in the drop-down list.
26699 Assembly Calyx RIM can incorrectly send a Native .PDF file to for extraction. Also, while a large file can fail extraction, it might not prevent successful publishing.
26642 Assembly Assembly files created by exporting an assembly to the Assembly File (XML) on versions of Calyx RIM starting with 6.2 CHF 4 cannot be imported to Calyx RIM versions 6.2 CHF 3 and earlier.
26637;

[INC0045216]

Administration In Data Administration, the Check for Date-based Notifications menu is not available on the Notification Specifications grid.

Calyx RIM Publisher

Issue Affected Area Description
DE28730 (Added on 4th of November, 2022) Assembly The published output location path for reference leafs is empty.
DE27966

(Added on the 1st of June, 2022)

Assembly The published output files are not exported to Documentum repository if they have Chinese characters in the file name.

Workaround: rename files as per eCTD normalization rules before exporting output.

DE27958

(Added on 1st of June, 2022)

Assembly After publishing the China assembly, China symbols are present in the name of the STF file. For example: stf- 4.2.1.1 药效学.xml

Workaround: rename files as per eCTD normalization rules before exporting output.

25259; [00052856] Create eCTD wizard When modifying Applicant Contact Values for M1 in a US 3-3 assembly, if you Deselect a value it does not re-appear in the selection box. As a workaround, you must save an entry with other contact values and then edit M1 again and select the Applicant Contact Value.
25084; [00051037, 00052759, 00056925, 00058862] Assembly Deleting large applications or removing multiple sequences from a lifecycle can take can take much longer than expected to produce results.
20270; [136797FW] Assembly Links for External Bookmarks are incorrect for split documents in paper published output.

Calyx RIM Registrations

Issue Affected Area Description
26821 Update Application wizard Trying to update the UUID field in the Update Application wizard resulted in the MetaField [submittorId] does not exist in MetaClass error message. This issue exists for the for the Applications of MAA type with the EU CTR Procedure type and will be resolved in Calyx RIM 7.2.

Workaround: Update the UUID field using Edit on Application Attributes page.

26818 Global Project Plan wizard When you run the Global Project Plan wizard for the Clinical Trial Project Type with the Create New Event for Existing CTA and/or IND Application(s) option and get to Select CT Shared Data, select a value and click Next, it takes a long time to proceed further. This performance issue will be resolved in Calyx RIM 7.2.

Workaround: Wait for the wizard to proceed.

Calyx RIM Outlook add-in

Issue Affected Area Description
DE26820 Outlook add-in form You cannot attach the following items from an e-mail in the add-in forms:
  • Contact - .vcf
  • Calendar (Event) - .ics
  • Outlook e-mails - e-mails without an extension (e-mail chain, single e-mail, and composed e-mail)
DE26804 Outlook add-in form When using the API GET request for retrieving the recipients from Microsoft Graph, if the search criteria contains a space, the following error is shown: 500 Internal Server Error
DE26803 Outlook add-in form In the Add Notification Recipients field, it is not possible to delete any spaces.
DE26782 Outlook add-in form If more than 50 users try to submit a form, the system fails and an error is displayed.
DE26781 Outlook add-in form When an API request with invalid product id is sent for CreateSubmissionAndReference, an incorrect error message is displayed.
DE26738 Outlook add-in form If Calyx RIM Outlook add-in fails to submit the forms, an incorrect error message is displayed.
DE26731 Outlook add-in form An auto-populate functionality does not work for the Product field in the Calyx RIM Outlook add-in forms if the product name starts with an article. Example: "The Product 01", "A Product 123"

In the Calyx RIM Outlook add-in forms, the auto populate does not work for product unless more than 3 characters are typed.

DE26715 Tool Box and Activity History When using the Calyx RIM Outlook add-in desktop version on Windows 10, version 2004 and Outlook version 1908, it is not possible to click the Export button on the Activity History Analysis page.
DE26711 Add-in meta overrides Trying to change the Calyx RIM Outlook add-in icon takes longer time than expected.
DE26704 Outlook add-in form Empty text files cannot be attached using the Browse File button.
DE26703 Add-in meta overrides In the Calyx RIM Outlook add-in desktop version, even after restarting the Microsoft 365 Outlook, the system fails to override the "Liquent InSight" launch icon.
DE26702 Outlook add-in form When trying to attach the files for the Calyx RIM Outlook add-in forms, ToolTips are not displayed for the following:
  • Attach from email button
  • Browse files button
  • "No available items to attach" ToolTip when all the attachments are already attached

Calyx RIM Rendering

Issue Affected Area Description
DE26968

(Added on the 23rd of December, 2021)

Assembly The assembly files cannot be published to Documentum if their size is 800 mb and more. The distribute job request fails.

Workaround: Ensure that the size of the assembly files is less than 800 mb.

DE28324; [TASK0043134, INC0109855]

(Added on the 12th of August, 2022)

Assembly Publishing to some printers may result in tab text misplacement.
DE26794 Assembly When eCTD assembly is published, the validation messages from the backbone generator are not displayed in Job Requests Details.