Published July 18, 2025 | Version v1
Publication Open

Guidelines for data sharing of investigator-initiated clinical studies

  • 1. ROR icon European Clinical Research Infrastructure Network
  • 2. ROR icon University of Cambridge
  • 3. ECRIN (European Clinical Research Infrastructure Network)
  • 4. ECRIN
  • 5. KKS-Network

Description

These guidelines are meant to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights and provide effective and efficient systems for preparing, storing and accessing data. By enforcing implementation of these guidelines, funders of clinical trials contribute to the principle that publicly funded research data is a public good, produced in the public interest and should be made openly available with as few restrictions as possible in a timely and responsible manner.

These guidelines have been adapted from ERA4Health’s original document D16.5 Guidelines for data sharing of investigator-initiated clinical studies.

Files

ERA4Health booklet Data Sharing Plan.pdf

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Additional details

Related works

Funding

European Commission
ERA4Health - Fostering a European Research Area for Health Research 101095426