The Open Call for DPs described in this document welcomes expressions of interest from any data custodian in Europe wishing to be considered as a candidate DP for DARWIN EU®. These include primary and secondary care data sources, claims databases, biobanks, etc. Being open to any data source, the Open Call is an instrument to facilitate a level playing field to any interested institution to participate in DARWIN EU® and aims to compile relevant information from candidate Data Partners to support decision making by the EMA to determine which DPs will be formally invited to join the initiative.

How to express interest?  

The first step is to add an entry for your data source(s) on the HMA-EMA Catalogue of Real-World Data (RWD) sources.

Required steps:

1. Go to https://catalogues.ema.europa.eu/catalogue-rwd-sources and click on the ‘Login’ button (in the top-right hand side of the header).
2. You will be directed to the EU Login webpage. On this page, choose the 'Create an account' option. After providing your personal information (First name, Last name and Email), you will receive an email with instructions to activate your account. For more guidance on how to log in to the RWD Catalogues, please refer to the Support section of the Catalogues website.
   Note: If you already have an EU Login, you can login to the RWD Catalogues with those credentials.
3. Go to ‘My dashboard’ > ‘Add content’ > ‘+ Data Source’ and fill out the webform page. When you have uploaded the desired information, click on ‘Save’. When finalised, submit the Data Source entry by changing the state of the entry from ‘Draft’ to ‘Submitted’. In case of multiple data sources, you need to submit separate entries for each data source, one at a time.
   Note: This document contains all question fields included in the webform page for offline review (if needed).
4. Go to ‘My dashboard’ and click on the title of the Data Source entry that you have just submitted (the moderation state of the entry should be ‘Submitted’). Once you enter the Data Source entry page, click on the ‘Download as PDF’ button (in the light blue title banner of the entry). Also, make a note of the link appearing in the PURI field in your entry (see ‘Administrative details’ section).

In case you have submitted multiple Data Source entries, repeat the same process to download a PDF file and get the PURI information for each entry.

Once the entry has been submitted, please send an email to This email address is being protected from spambots. You need JavaScript enabled to view it. and copy This email address is being protected from spambots. You need JavaScript enabled to view it. in the email communication. The email should contain the pdf document(s) of the Data Source(s), the PURI link(s) to your HMA-EMA Catalogue entry (or entries) and a one-paragraph motivation for joining DARWIN EU® as a data partner. This email with attachments is considered as your Expression of Interest (EoI).

What happens after submission of the Expression of Interest?

• Upon receipt, the DARWIN EU Coordination Centre (CC) will acknowledge receipt by email reply to the sender. The provided information will be checked by the CC for completeness, consistency and scope.
• Expressions of Interest that are deemed to be incomplete, inconsistent, or out of scope will be rejected at that stage, and the candidate will be informed accordingly by email within two weeks from the receipt date.
• Rejected submissions due to lack of completeness or consistency can be re-submitted after correcting the HMA-EMA RWD Catalogues entry. In this case, your entry to the RWD Catalogues will be returned to you and you will be able to edit the record and resubmit it. Once you resubmit your data source record, step 4 (as described earlier) will need to be repeated. As soon as the CC reviews and approves the amended information, you will receive a separate email notification that your data source entry is now published in the RWD Catalogues.
• If an Expression of Interest is deemed to be out of scope, this does not affect the publication to the RWD Catalogues. Your data source entry will still be published in the HMA-EMA RWD Catalogues but will not be considered for potential DP.

All other EoIs will become part of a list of interested potential DPs. This list will be reviewed by the CC and the EMA at least twice a year, corresponding to EoIs received on or before the following dates every year:

30^th April

31^st October

Although these are deemed to be the ordinary cut-off dates, the CC and the EMA reserve the right of reviewing applications at any point in time, depending on the needs of the network and forthcoming studies. Following a request from the EMA, the CC may announce the termination of this Open Call for DPs.

The review process will examine all Expressions of Interest and consider factors such as type of data, size, geographical representativeness, added value to the network, perceived data quality, governance procedures, coverage of specific populations, past experience in studies, potential intention to convert data to or status of the mapping to the OMOP CDM, etc., and will result in a short list of DPs to be approached. Final decision on the short list rests with the EMA considering the current and future needs for studies.

Shortlisted DPs may then be approached by the CC to discuss outstanding questions with CC/EMA experts, or be directly invited to initiate the formal onboarding process, which consist of several steps and finishes with the signature of an agreement with the CC (see Related Documents), which signals the official participation in DARWIN EU® as a Data Partner.  

It is important to note that no guarantees are given to any candidate DP as regards their selection or effective incorporation into DARWIN EU® until the onboarding process is successfully completed and the agreement with the CC has been signed. Conversely, submission of an EoI is non-binding for candidate DPs, and they may withdraw from the selection process if no longer interested.

All received EoIs will remain in the list of interested potential DPs (unless the applicant expresses a wish to be removed through the email address mentioned above) and can be shortlisted in any review round.

Additionally, the Expression of Interest form allows DPs to explicitly agree that the information they submit is automatically included in the public EMA Metadata Catalogue of data sources, increasing their discoverability to researchers for the conduct of other scientific studies.

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  Data Partner Framework Agreement (PDF/620KB)

  First published: 18/12/2023

   
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  Expression of Interest (XLSX/188KB)

  First published: 26/03/2023