Release Notes

Features and bug fixes released since last update

Feature to re-direct study links from the former EU PAS Register to the migrated specific study in the RWD Catalogues

The individual studies indexed in the EU PAS Register had specific individual links. This feature re-directs the user to the specific study record migrated in the RWD Catalogues when the user clicks on the links.

Increase character limit for study objectives and study description fields

The character limit was increased to 10,000 characters for the study objective and study description fields. Previously cut off words due to the migration was re-instated automatically.

Uploading files

The user is able to upload more than one file in the following fields: 

  • 'Composition of steering group and observers' ('Add a Study' form).
  • 'Conflicts of interest of investigators’ ('Add a Study' form).
  • 'Procedure of results generation' ('Add a Study' form).
  • 'Protocol document' ('Add a Study' form).
  • 'Results tables' ('Add a Study' form).
  • 'Signed checklist for study protocols' ('Add a Study' form).
  • 'Signed code of conduct' ('Add a Study' form).
  • 'Signed code of conduct checklist' ('Add a Study' form).
  • 'Study report' ('Add a Study' form).
  • 'Study, other information' ('Add a Study' form).
  • 'Data characterisation details' ('Add a Data Source' form).
  • 'Governance details' ('Add a Data Source' form).
     
'Add a Study' form: 'Medical Conditions to be studied' field

The drop-down menu for this field displays more than a limited number of options. The missing values are displayed in the 'Study' record.

'Add a Study' form: 'Study drug International non-proprietary name (INN) or common name' field

The user can choose more than one value in this field. The missing values are displayed in the 'Study' record.

'Add a Study' form: 'Study timelines' field

The user can fill in the Actual dates in 'Study timelines'. To edit an Actual date previously validated, the user needs to raise a ticket in ServiceNow.

Linked studies displaying under an Institution

All studies linked to a specific Institution are displayed in the institution record. 

'Add a Study' form: Correct text labels in ‘Study timelines’

There was a discrepancy between the texts shown in the ‘View’ mode and ‘Edit’ mode (e.g., ‘Data collection’ field in ‘View’ mode and ‘Study start date’ field in ‘Edit’ mode).

Export the record as PDF for Draft records

The user can export the record page for records in ‘Draft’ state.

'Add a Study' form: Display issue with fields in section ‘Methodological aspects’

The fields ‘Scope of the study’, ‘If ‘other’, further details on the scope of the study’ and ‘Data collection methods’ only appeared when the user selected ‘Study type’ as ‘Non-interventional’, when in fact they should appear in every case.

'Add a Data Source' form: 'Data Holder'

Possibility to find the 'Data Holder' of the Data Source registered in the Catalogues by searching for the Institution name instead of having to scroll-down through the list.

Notification system, Subscription functionality

Visitors and users can subscribe to a study record and receive email notifications whenever the study is updated.

Save progress through steps in the record form     

The filled information while navigating through steps in the 'Add a Study' and 'Add a Data Source' forms are saved in case the user is disconnected.

Features in release pipeline

User notification system
Estimated timeline: Q3 2024

A notification system will allow users to receive email notifications on record submission and validation, annual update of records, study milestone reminders, change of authorship and collaboration request/co-author added.

'Add a Data Source' form: 'Data Holder'
Estimated timeline: Q3 2024

Allow both institution and network to act as a Data Holder of a data source.

New fields in the ‘Add a Data Source’ form 
Estimated timeline: Q3 2024

The news fields in the 'Add a Data Source' form will collect information on omics data collected by the data source.

Enhanced search functionality
Estimated timeline: Q4 2024

The user will be able to search data sources by data source acronym. There will be more filters to search for studies (e.g., ATC code).

Integration with EMA corporate website
Estimated timeline: Q4 2024

Catalogue records will be visible in the relevant medicines overview page, on the EMA website, linking to summary of Risk Minimisation Plans, EPARs, Product Information, etc.

Change authorship of a record by user/editor 
Estimated timeline: TBC

The user will be able to transfer the record ownership to another user in the authorship information at the end of the form using the username of the new owner.

Enable search function in “My Dashboard”
Estimated timeline: TBC

The user will be able to search within their records in the “My Dashboard” page.

Search data source in the ‘Add a Study’ form via the ‘Data source acronym’ field
Estimated timeline: TBC

In Step 3 (Data management) of the study form, the field ‘Data source(s)’ only searches for data sources via their full name. This will enable the search via the data source acronym.