What's new
This page contains the summary of the expected improvements and known issues that will be addressed in the near future for the Real-World Data Catalogues. Release notes are updated every 3 months. Next update is expected in January 2025.
This page contains the summary of the expected improvements and known issues that will be addressed in the near future for the Real-World Data Catalogues. Release notes are updated every 3 months. Next update is expected in January 2025.
When a user logs into the Catalogues for the first time, they receive a welcome email.
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).
Authors receive collaboration request emails whenever they are invited to become a co-author of a record.
Authors receive a confirmation email whenever they submit updated information for validation (i.e., the status of their record changes to “Submitted”).
Authors receive a confirmation email whenever their record is validated, indicating the outcome of their submission (i.e., “Published” or “Returned”).
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.
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.
The following filters have been added to the Study search:
The following filter has been added in the Data source search:
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.
A new optional field has been added to the ‘Add a Data Source’ form to indicate the species associated with a veterinary data source.
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.
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.
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.
Authors of an institution receive a reminder one year after the last update, prompting them to ensure that the information is up to date.
Authors of a network receive a reminder one year after the last update, prompting them to ensure that the information is up to date.
Several formatting issues in the PDF exports have been resolved, including the display of special characters and the availability of previously missing fields.
Users can search for and retrieve studies via the text from the ‘Other study ID’ field.
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.
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.
The user is able to upload more than one file in the following fields:
The drop-down menu for this field displays more than a limited number of options. The missing values are displayed in the 'Study' record.
The user can choose more than one value in this field. The missing values are displayed in the 'Study' record.
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.
All studies linked to a specific Institution are displayed in the institution record.
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).
The user can export the record page for records in ‘Draft’ state.
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.
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.
Visitors and users can subscribe to a study record and receive email notifications whenever the study is updated.
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.
Catalogue study 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.
The Catalogues’ homepage will include a banner with counts of records per type (i.e., data sources, studies, institutions, networks) that are published.
The landing pages of the Catalogue of data sources and the Catalogue of studies will include a map of the geographical spread of data sources and studies by country.
The published data sources will have a “Metadata completeness score” field (available in the data source search page and in the individual records) to indicate the percentage of fields that have been filled out in a data source record. The completeness score refers to the number of metadata fields completed in the data source record and will not be intended as an indication of data quality.
Data sources that have not been updated in 2 years and institutions/networks that have not been updated in 5 years since their last update will be marked as “Outdated” with a dedicated tag that will appear in the record banner. A filter for outdated/current records in the filter options will also become available, to be able to limit the results by excluding outdated records.
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.
The user will be able to search within their records in the “My Dashboard” page.
The data source records will contain more detailed information on the type of data collected, more specifically focused on omics data (e.g. proteomics, metabolomics, transcriptomics).
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.