Guidelines for data sharing of investigator-initiated clinical studies

Produced as ERA4Health Deliverable D16.5 (Work Package 16) and led by the European Clinical Research Infrastructure Network (ECRIN), supporting Good Clinical Practice and General Data Protection Regulation (GDPR)‑compliant data sharing with appropriate informed consent, privacy protection and governance. Structured, stepwise guide to preparing data sharing plans for clinical trials, from grant application to repository deposit and controlled access to Individual Patient Data (IPD). Target audience includes funders, grant applicants, coordinating investigators, research staff, patients’ groups, academia, industry, reviewers and regulatory and ethics authorities involved in multinational clinical trials.

How the guideline is structured as a concise report with sections on purpose and objectives, scope, methodology, data sharing plan preparation guidelines, a data sharing plan checklist, conclusions, references and seven annexes.
Purpose and scope explain why funders require data management and data sharing plans, how IPD sharing enables re‑analysis, IPD meta‑analyses and artificial intelligence development, and how the guidance supports GDPR compliance and European and international funder expectations for investigator‑initiated multinational clinical trials.

Core content (Section 4)
Data sharing plan preparation guidelines built around the data lifecycle: early planning at proposal stage (protocols, trial registration and grant applications), governance and responsibilities, and alignment with funder and institutional policies.
Covers data protection concepts (pseudonymisation, anonymisation, Data Protection Impact Assessment (DPIA), Health Data Access Bodies), dataset preparation, use of health data standards (for example Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), Health Level 7 (HL7)), metadata and documentation, sharing of trial documents, repository selection, FAIR data, access conditions and contractual arrangements (data processing and data sharing agreements).

Annexes and practical tools
Annex 1: example wording for describing data sharing in a trial protocol.
Annex 2: key points for consent language on secondary use of data.
Annex 3: example DPIA content for clinical trials.
Annex 4: list of key health data standards for clinical research (including CDISC, HL7 and related terminologies).
Annex 5: examples of repositories suitable for sharing clinical research data.
Annex 6: data sharing roadmap
Annex 7: data sharing plan checklist to help trial teams and applicants ensure governance, protection, documentation, repository choice and access conditions are covered.