September 10, 2025
25R2.0.44
Scheduled for release on September 10, 2025.
| Category | Description | Issue No. |
|---|---|---|
| RIM Basics | Users can now import eCTD Submissions with invalid XML. | DEV-923570 |
September 3, 2025
25R2.0.VB5
Scheduled for release on September 3, 2025.
| Category | Description | Issue No. |
|---|---|---|
| Quality Basics | The Automatically Enroll Learners field on Learner Roles is now locked while the Learner Role is in the Ready for Use state. | DEV-920197 |
| Quality Basics | Users no longer receive an erroneous error email regarding automatic check-in during the Authoring/Review workflow. | DEV-920197 |
August 27, 2025
25R2.0.VB4
Scheduled for release on August 27, 2025.
| Category | Description | Issue No. |
|---|---|---|
| Quality Basics | Extension Requests now display the Workflow Timeline during the Update Request state. | DEV-909739 |
| Quality Basics | The Documents with Inactive Owner report now returns results correctly. | DEV-909739 |
| Quality Basics | The Learner Curriculum Completion report now returns results correctly. | DEV-909739 |
| RIM Basics | The Primary Health Authority for Serbia is now the Agency for Medicines and Medical Devices of Serbia. | DEV-919022 |
25R2.0.36
Scheduled for release on August 27, 2025.
| Category | Description | Issue No. |
|---|---|---|
| Clinical Basics | A new Include on Site Letters? field is now available on Issues. | DEV-891350 |
| Clinical Basics | A new Protocol Version field is now available on Issues. | DEV-891350 |
| Clinical Basics | The Monitoring Follow Up Item page layout’s Completion Date and Completion Details fields have been moved to a new Completion Details section. | DEV-891350 |
| Clinical Basics | The Completion Details field referenced above is now required in order to resolve a Follow Up Item. | DEV-891350 |
| Clinical Basics | Monitoring Follow Up Letters now capture Issues and additional Follow Up Item fields. | DEV-891350 |
| Clinical Basics | A new All Issues tab is now available when navigating to Study Management > Issues. | DEV-891350 |
| Clinical Basics | A new Subject Visits tab is now available when navigating to Study Management > Subjects. | DEV-891350 |
| Clinical Basics | Subject Visits are now automatically updated if SDV is completed on related Monitored Subject Visits. | DEV-891350 |
| Quality Basics | In Tips for User Setup, “Read-only Non-GxP User” Security Profile is now named “Non-GxP Read-only User.” | DEV-913531 |
August 20, 2025
25R2.0.VB3
Scheduled for release on August 20, 2025.
| Category | Description | Issue No. |
|---|---|---|
| RIM Basics | A Country Decision Details section now appears on the Regulatory Objective page layout when more than one country is associated with the application. | DEV-917036 |
| RIM Basics | The Country Decision Details section referenced above now includes a Country Decision Date field. | DEV-917036 |
| RIM Basics | The Country Decision Detail lifecycle now allows users to revert from the Procedure End/Opinion state to the In Progress state. | DEV-917036 |
| RIM Basics | The Regulatory Objective page layout now includes a Related Documents section. | DEV-917036 |
August 18, 2025
25R2.0.VB2
Scheduled for release on August 18, 2025.
| Category | Description | Issue No. |
|---|---|---|
| PromoMats Basics | Material Coordinators are now able to upload new versions of documents in the Ready for Review state. | DEV-909763 |
August 13, 2025
25R2.0.VB1
Scheduled for release on August 13, 2025.
| Category | Description | Issue No. |
|---|---|---|
| RIM Basics | The Expected Acknowlegdements field on Applications now auto-populates. | DEV-909233 |
| RIM Basics | The Application Folder Name field is now a required field. | DEV-909233 |
| RIM Basics | Updated Content Plan Item Templates (CPITs) with the Create as Active field not set are now set to a value of “No”. | DEV-909233 |