D16.5 Guidelines for data sharing of investigator-initiated clinical studies
Creators
-
1.
European Clinical Research Infrastructure Network
- 2. ECRIN (European Clinical Research Infrastructure Network)
- 3. ECRIN
- 4. Netzwerk der Koordinierungszentren für Klinische Studien
Description
The objective of this task is to provide general guidance for preparing data sharing plan for clinical studies, including guidance on informed consent (ICF) for secondary use of data and long-term storage of data, especially Individual Patient Data (IPD) in repositories following the FAIR (Findable, Accessible, Interoperable and Reusable) principles. This guide outlines the process of developing a data sharing plan GDPR compliant and in alignment with the EU and international funders expectations and provides practical guidance on how to meet them. It should be of relevance to stakeholders (funders, grant applicants, coordinating-investigators, research staff, patients’ groups, researchers, academia, professional groups, industry, reviewers, and regulatory and ethics authorities) involved in investigator initiated multinational clinical trials.
Files
16.5 Guidelines for data sharing of investigator-initiated clinical studies.pdf
Files
(1.6 MB)
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