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.