How to join the data network?
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 process is simple. DPs interested need to provide information on their data source(s) through an Expression of Interest (EoI) form. At the moment, this form is an Excel spreadsheet, which is accessible here:
Potential DPs should download the form and complete it offline. Once the form is duly completed, it must be sent by an authorised representative (i.e. person in the institution with authority to submit such applications) to the following email address:
What happens after submission of the Expression of Interest?
Upon receipt, the CC will acknowledge receipt by email reply to the sender. Each Expression of Interest correctly received 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 informed correspondingly within two weeks from the receipt date. Rejected submissions due to lack of completeness or consistency can be re-submitted after correcting the EoI.
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:
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.
FAQ Open Calls
The information contained in the EoI will primarily be used for the purposes of evaluating candidacy to formally become a DARWIN EU® Data Partner. You can access the associated Data Protection Notice here. Additionally, by providing consent in response to a specific question in the EoI form, you as the potential DP agree that your EoI information will be used to populate the EU Metadata Catalogue, which is an EMA initiative to help improve data discoverability and transparency. The Catalogue is intended for public use, and you can read its associated Data Protection Notice here.
5. I have been contacted by the CC after my submission, does it mean that I am officially a DARWIN EU® data partner?
The onboarding process consists of several quality and technical checks to ensure readiness for DARWIN EU® studies, plus explanation of the terms and conditions for participation and agreement on the legal provisions that will apply to the relationship between you and the CC. Its duration can vary between 1 and 2 months, ordinarily.