ERA4 HEALTH PROJECT ANNOTATED TEMPLATE MODEL FOR AN EU CLINICAL SITE AGREEMENT ("EU CSA") V2

ERA4 HEALTH PROJECT ANNOTATED TEMPLATE MODEL FOR AN EU CLINICAL SITE AGREEMENT ("EU CSA") V2 | Zenodo Skip to main Communities My dashboard Log in Sign up ECRIN Published February 16, 2026 | Version v1 Other Open ERA4 HEALTH PROJECT ANNOTATED TEMPLATE MODEL FOR AN EU CLINICAL SITE AGREEMENT ("EU CSA") V2 Authors/Creators Matei, Mihaela 1 del Alamo, Marta 2 Lémeret, Sabrina 1 Show affiliations 1. European Clinical Research Infrastructure Network 2.

ECRIN (European Clinical Research Infrastructure Network) Description This template is developed taking into consideration existing national frameworks and is applicable across Europe to facilitate clinical site agreements in multinational clinical studies. This version of the EU CSA is the result of collaborative work involving national experts across the EU. Even though not all EU countries have been represented in the project, we are confident that most of the provisions are acceptable to many EU countries, as the Legal task group is composed of lawyers and experts coming from very diverse national jurisdictions. PURPOSE OF THE AGREEMENT The purpose of this Agreement is: 1. to set out the rights, responsibilities, and obligations of the Parties regarding the conduct of the Trial at the Clinical Site 2. to define the responsibilities and obligations of the Parties in relation to the personal data processing activities involved in the conduct of the Trial Note: The development of this deliverable also involved consultation with external experts. For reasons of confidentiality, the full list of contributors involved in its drafting and review will be published once their consent to the public disclosure of their names and affiliations has been obtained Files Clinical Site Agreement_V02_Revised version_29012026_Annex3.pdf Files (1.3 MB) Name Size Download all Clinical Site Agreement_V02_Revised version_29012026_Annex3.pdf md5:5474414d5a1c25df9221ff52b6ea336d 1.3 MB Preview Download Additional details Related works Is published in Project deliverable: 10.5281/zenodo.19492560 (DOI) Funding European Commission ERA4Health Phase 2 - European Partnership fostering a European Research Area (ERA) for health research (Phase 2) 101260203 217 Views 205 Downloads Show more details All versions This version Views Total views 217 217 Downloads Total downloads 205 205 Data volume Total data volume 351.1 MB 351.1 MB More info on how stats are collected.... Versions External resources Indexed in OpenAIRE Communities Details DOI DOI Badge DOI 10.5281/zenodo.19492643 Markdown [](https://doi.org/10.5281/zenodo.19492643) reStructuredText .. image:: https://zenodo.org/badge/DOI/10.5281/zenodo.19492643.svg :target: https://doi.org/10.5281/zenodo.19492643 HTML <a href="https://doi.org/10.5281/zenodo.19492643"><img src="https://zenodo.org/badge/DOI/10.5281/zenodo.19492643.svg" alt="DOI"></a> Image URL https://zenodo.org/badge/DOI/10.5281/zenodo.19492643.svg Target URL https://doi.org/10.5281/zenodo.19492643 Resource type Other Publisher Zenodo Rights License Creative Commons Attribution 4.0 International The Creative Commons Attribution license allows re-distribution and re-use of a licensed work on the condition that the creator is appropriately credited. Read more Citation Export Technical metadata Created April 10, 2026 Modified April 16, 2026 Jump up About About Policies Infrastructure Principles Projects Roadmap Contact Blog Blog Support Help FAQ Developers REST API OAI-PMH Contribute GitHub Donate Funded by Powered by CERN Data Centre & InvenioRDM Status Privacy policy Cookie policy Terms of Use This site uses cookies. Find out more on how we use cookies Accept all cookies Accept only essential cookies

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