What's new

Integration with EMA corporate website

Users can access RWD studies published in the Catalogues via the EMA corporate website for centrally authorised medicines. This linkage, visible on the EMA medicines page, enables to quickly access relevant RWD studies for the medicine(s) in question.

Enhanced text search with AND/OR functionality

The text search function includes an option for users to choose between "Contains all of these words" and "Contains any of these words" when conducting a free-text search with multiple terms. This feature enables more precise and flexible searches within the Catalogues.

New tab ("Resources") added to study records

A new tab called “Resources” is now available where all study related documents (e.g., protocol, results) are grouped together for improved findability. Study authors will be able to find the already uploaded documents under this tab.

Additional filters for study search

Users can filter for study population age groups, special populations (e.g., pregnant women), and non-interventional study design.

Additional filters for data source search

Users can filter for population age groups and data source collection time span.

Share a page via BlueSky

Users are able to share pages, including published records, directly via BlueSky from the Catalogues.

Users cannot remove uploaded protocols

Once study authors upload a protocol document in the Edit view, this document cannot be removed by the author for transparency reasons. Authors can upload multiple revisions of the original protocol to reflect any protocol changes.

Record version status and differences in the "Revisions" tab of a record

The "Revisions" tab shows version status: Draft, Submitted, Published. This tab helps record authors keep track of different stages of their record and compare versions to see changes made.

Country flags not being displayed

All country flags are visible in both the record pages and the search page.

Summary of Record Counts in the Catalogues' Homepage

The Catalogues’ homepage includes a banner that provides an at-a-glance overview of the content available in the Catalogues. This banner displays the counts of published records for each type (i.e., data sources, studies, institutions, networks).

New Fields for Study Records: "Cancelled" and "Discontinued" Studies

Study questionnaires have two new fields: "Cancelled" and "Discontinued". These fields have been introduced to provide more transparency and clarity regarding the status of studies that were planned but cancelled before commencement (“Cancelled”) or initiated but terminated before completion (“Discontinued”).

Search Functionality in “My Dashboard”

Authors can search within their records in the “My Dashboard” page.

Search for a Data Source in the ‘Add a Study’ Form via the ‘Data source acronym’ Field

Authors can search for data sources using their acronyms in the ‘Data source(s)’ field of Step 3 (Data management) in the study form, in addition to searching by their full names.

New Filter for DARWIN EU Data Partners

Visitors of the platform see a new filter for data sources on the site-wide search page allowing them to display only data sources that are DARWIN EU data partner. This enhancement makes it easier for users to find and focus on data sources associated with DARWIN EU. Additionally, the field “DARWIN EU partner” has been added to the csv export file.

Notification System - User Registration Notification

When a user logs into the Catalogues for the first time, they receive a welcome email.

Notification System – Change of Authorship and Co-authors Added

Authors receive confirmation emails whenever there is a change in the list of record authors (i.e., when authors are added or removed from a record).

Notification system – Collaboration Requests

Authors receive collaboration request emails whenever they are invited to become a co-author of a record.

Notification System - Record Update Notifications

Authors receive a confirmation email whenever they submit updated information for validation (i.e., the status of their record changes to “Submitted”).

Notification System – Record Validation Outcome

Authors receive a confirmation email whenever their record is validated, indicating the outcome of their submission (i.e., “Published” or “Returned”).

'Add a Study' form: Study Start Date –Definition Modification

The definition of study start date has been updated to: "Start of data collection date. For primary data collection, this is the date from which information on the first study subject is recorded. For secondary use of data, this is the data extraction start date”. 

A help text has been added to the form to assist authors in filling out the field with the correct information.

'Add a Data Source' form: "Data holder” Drop-down List Modification

The data holder field in the 'Add a Data Source' form has been updated to allow both institutions and networks to act as data holders. Users can now select a network as a data holder when registering a data source.

Search Functionalities – Additional Filters for Study Search

The following filters have been added to the Study search:

• ATC code: Filter based on Anatomical Therapeutic Chemical (ATC) codes.
• Substance (INN): Filter based on active substances using Substance Management Service (SMS) terms.
• Name of medicine: Filter based on the medicinal product name.
• Medical condition: Filter based on the Medical Dictionary for Regulatory Activities (MedDRA) term describing the medical condition.

Search Functionalities - Data Elements Collected in the Data Source Search

The following filter has been added in the Data source search:

• Data elements collected: This filter allows users to retrieve results based on the specific data elements that are recorded in the data source records (e.g., diagnosis, clinical measurements, cause of death, etc).

'Add a Data Source' form: Data Domain Field

A new field has been added to the ‘Add a Data Source’ form to indicate the relevant domain of the data source, specifying whether it collects information on humans or animals. The field is also available in the filters of the Data source search.

'Add a Data Source' form: Species Field (for Veterinary Data Sources)

A new optional field has been added to the ‘Add a Data Source’ form to indicate the species associated with a veterinary data source.

Notification System - Reminder Notification (Planned Start of Data Collection)

Authors of a study receive a reminder about the data collection on the day specified in the "Study start date (planned)” field. This reminder helps them keep the record up to date in case the planned date for data collection has changed.

Notification System - Reminder Notification (Final Report Planned Date)

Authors of a study receive a reminder about the final report one day after the date specified in the "Final study report date (planned)" field. This reminder helps them keep the record up to date in case the planned date for completing the final study report has changed.

Notification System - Reminder for Data Source Record Updates (1 Year After Last Update)

Authors of a data source receive a reminder one year after the last update, prompting them to ensure that the information is up to date.

Notification System - Reminder for Institution Record Updates (1 Year After Last Update)

Authors of an institution receive a reminder one year after the last update, prompting them to ensure that the information is up to date.

Notification System -Reminder for Network Record Updates (1 Year After Last Update)

Authors of a network receive a reminder one year after the last update, prompting them to ensure that the information is up to date.

Resolution of PDF Export issues 

Several formatting issues in the PDF exports have been resolved, including the display of special characters and the availability of previously missing fields.

Search Functionalities - Enable Search of Studies via 'Other study identifiers'

Users can search for and retrieve studies via the text from the ‘Other study ID’ field.

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.