To be considered as a candidate DP, the first step is to create an entry in the HMA-EMA Catalogue of Real-World Data sources.

Yes, unless duly justified, in which case an appropriate justification should be included.

The HMA-EMA Catalogue of Real-World Data source is intended for public use, and you can read its associated Data Protection Notice here.

You can access the DARWIN Data Protection Notice here.

No, this is a continuously open call, but please bear in mind the cut-off dates (30th April, 31st October) for review and selection.

No. The CC may contact you to clarify certain aspects of your datasets, or to invite you to initiate the formal onboarding process. Until the latter is successfully completed and an agreement signed, you are not a DARWIN EU® DP.

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.

No. The onboarding process has to be successfully completed and an agreement with the CC has to be signed.