Calyx RIM 6.2 Release Notes

List of Enhancements: Calyx RIM 6.2 CHF 5

Requested new features and enhancements are included in each release. The items are listed in descending order by their tracking numbers. Customer case numbers that were recorded when the enhancements were requested are included in brackets [#####] following the tracking number.
Issue Build Hotfix Build Description
26549, 25730;

[00058042, 00063209]

6.2.0.5.0055 6.2.0.4.0104 Added functionality required to embed PDF content into submission XML according to the EAEU HA requirements.
26542 6.2.0.5.0055 6.2.0.4.0104 Added functionality to auto-populate the Output Folder with metadata values from Solvent and Drug Substance extensions for EAEU submissions.
26541 6.2.0.5.0055 6.2.0.4.0104 Added the ability to provide Solvent metadata for EAEU submission XML. Details of the new guidance can be found at: https://www.regmed.ru/download/eaeu/ToEaeuApplicants_DossierUpd_20200323_1.pdf
26519;

[PRB0040530]

6.2.0.5.0055 N/A When diagnosing issues that required a restart, the data_exchanger.log and server.log files were cleared out after the restart. The configuration has been modified to prevent the log files from being cleared out after restart, and messages are continually added to the existing log files.
26512 6.2.0.5.0055 6.2.0.4.0104 Mass Update Properties was available for Calyx RIM with the SPT license, but not with the ELP license. This issue is resolved. Mass Update Properties functionality is now available for clients with Electronic Lifecycle Publishing (ELP) licenses.
26508 6.2.0.5.0055 6.2.0.4.0104 The eCTD Import wizard now supports the import of EAEU submissions with embedded PDF content and submissions with PDF file references from the submission XML.
26496;

[INC0025048]

6.2.0.5.0055 N/A When creating a new working assembly using the Create eCTD wizard in an EU MRP application, the country metadata for the subsequent countries is copied as the default country metadata from the first country page except for the Agency name, Applicant, and Invented Name values even if a new country was added to the application.
26480;

[INC0023770]

6.2.0.5.0055 N/A The new Mass Update feature enables you to update a MedDRA Version for multiple indications/intended use data administration values entities simultaneously.
26450;

[CS0092205]

6.2.0.5.0055 N/A Memory usage is optimized when publishing very large submissions in Calyx RIM 6.2 CHF 5.
26416 6.2.0.5.0055 N/A The new List of Events with Change Details query enables you to view events that are associated with change, change details, and event change details.
26387 6.2.0.5.0055 N/A The uniqueness constraint for the EudraCT Number on a protocol has been removed in this release. A study or the clinical trial shared data can now include a redundant EudraCT Number.
26359 6.2.0.5.0055 N/A You can automate the inactivation of registration attachments once the corresponding acknowledgment is received via the XEVMPD Acknowledgement wizard. This option can be configured through application setup. By default, the option is disabled. These updates will not appear in the XEVMPD Audit Report.
26358 6.2.0.5.0055 N/A To make the XEVMPD Audit Report more concise and efficient, the following inconsequential results have been removed from the report:
  • Automated updates when an EV Code or the Validity Declaration is assigned
  • MedDRA Code and MedDRA Version when changes are made to them
  • Rows added for each country when an indication is added or modified for EU CP
  • Updates performed by SYSMAINT user.
26357 6.2.0.5.0055 N/A You can categorize the Full Product Presentations that are ready to be submitted to XEVMPD with the help of the new XEVMPD Submission Required? option.
26356 6.2.0.5.0055 N/A Extra fields can be updated in bulk on the Event Change Detail when the Details are associated to the Event via the Project > Associate Change Detail(s) to Events wizard. For details, please contact your Business Development Representative to consult with our Client Enablement team.
26354 6.2.0.5.0055 N/A The new System Process Default Flag provides the ability to assign several display statuses to the same Internal System Status in Data Administration for Application, Event-Change Detail, Product, Product Detail Set, and Sequence. You can see the assigned status after running the wizard or when the Event is closed manually. Before, the system randomly selected the first status that was mapped to the Internal System Status and you could not define which statuses would show after the updates.
26321;

[INC0013546]

6.2.0.5.0055 N/A It is now possible to create a folder or a leaf with an extension other than Default and extended attributes populated using a single API call.
26265 6.2.0.5.0055 N/A You can identify when any SPOR Maintenance value was created and by whom. These fields are added:
  • Created By
  • Created Date
26264 6.2.0.5.0055 N/A You can identify when any Data Administration value was created/last modified and by whom. These fields are added:
  • Last User Updated
  • Last Changed Date
26204;

[00064468]

6.2.0.5.0055 N/A The full field value can be viewed in Data Administration when you create or modify the pick list.
26095; [00063365] 6.2.0.5.0055 N/A Calyx RIM 6.2 CHF 5 requires one of these Oracle versions:
  • Oracle 19c (12.2.0.3) - 12.2.0.3.0 Standard Edition 2
  • Oracle 19c (12.2.0.3) - 12.2.0.3.0 Enterprise Edition
24325 6.2.0.5.0055 N/A Calyx RIM now retains the site folders in M5 after importing the study reports as node extensions.
24532, 20873;

[00044627, 00037898]

6.2.0.5.0055 N/A New job statuses are introduced for Job Requests:
  • Completed with Errors
  • Completed with Warnings
23803

[00039687]

6.2.0.5.0055 N/A In an assembly, you can update the Folder or Leaf extension value from the Change Type > Extension without switching to the Default value.